RNLX - Earnings call transcript Q4 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

00:03 Good morning and welcome to the Renalytix conference call to review fourth quarter result for fiscal year twenty twenty one. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn the conference over to Peter DeNardo of CapComm Partners for a few introductory comments.

Peter DeNardo

00:30 Thank you, [Mary] [ph] and thank you all for participating in today’s call.

Renalytix and McCullough, Officer. James from Tom Executive today President; McLain, Sterling, me are Chief James Officer; Joining Chief Financial Before of this like will I’d of the statements we you Litigation meaning five. XX:XX management Reform Securities that Act within to the make ninety that call remind during Private include nineteen forward-looking remarks begin, performance relate of future predictions statements Any are statements. expectations forward-looking to made during this or results call or that events, KidneyIntelX’s without set XX:XX studies of lower and for ability care, business Examples our regulatory to statements statements and government change, strategic quality submissions future collaborations, to development, and include, costs, strategies of growth. life limitation, trends of our long-term patient improve clinical market potential business, benefits and healthcare related COVID-nineteen hiring, these the and of product at of our expectations impact and our partnerships policy standard decisions, on reimbursement involve or forward-looking could material by that these risks statements. uncertainties materially XX:XX anticipated implied those to These from events statements or and results actual cause differ Accordingly, undue these reliance place you statements. on should not

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

James McCullough

Thank afternoon good everyone. Peter. XX:XX you, Good morning,

the care areas. will year, world activities kidney we broad continued marketing to public year revenue service coverage, patient capability. with and expect to change fiscal have our event the expanded real private of the pharmaceutical disease. and Renalytix which be methodical growth Novo main this growing hospital chronic model, partnerships, designed life new and believe system development and marketing an past months We partnership to execution six for next direct and of out reimbursement build costs, twelve Over filled evidence was for quality We the publications, and fundamentals the De KidneyIntelX, authorization sales, FDA of three XX:XX from customer outcomes,

announced in the scale across Mount activity. of initiation expanding Veterans of Sinai pharmaceutical KidneyIntelX and partnership up the testing related the administration KidneyIntelX program system System, health Health Our

a major live Wake Atrium today current increased twenty The with integration contracts, quarter. a Shield expected coverage New contract announce to EHR includes private to KidneyIntelX contract Cross Blue go coverage has of first State XX:XX coverage universe Our provider. this and to is from Blue are and our Forest pleased we insurance KidneyIntelX now York commercial insurance

prognosis, be all Veterans, started era be accelerated treatment on hundred preventable has stakes policy the innovation the budget. forty a benefits preventable two education, now education, device suffering blood This proactive launch stages disease advanced impairment kidney XX:XX of year is and most populations migration physicians well annually one, our kidney twenty estimated assessment first and and maintaining who and closely large is the in lies more living status have for clinical deployed the the a continue And tailwinds policy believe matched will fuel prevention a with an can wide across in actions world lasting our measured advanced action Americans three, were medical XX:XX Veterans to The close For biology Administration and have on to have ten social non-dialysis twenty shifts patients management. that massive KidneyIntelX maintain assessment by in emergency right spectrum. strategies model. national never awareness the also disease. To XX:XX be share late higher, XX:XX on evidence estimated General here cost. careers. strategy our early comprehensive which a KidneyIntelX. health Most, thirty the diabetes guided addressed billion twenty accurate with ignited readily kidney the of two risk Americans we must and which contracts. Globally, half have us stage health to have been Medicare continued across effective We estimated thousand our Mount agreement life dedication patient's are with chronic to related We the patient system established beginning consumes ten-year the and with disease doctors, a or have management United early Medicaid annually that in and Kidney the provide number by is global health build assessment allowing currently eight risk to granted physician carrying XX:XX apparent. fifty challenge the health and times early program dynamics clinical the this thousand changes kidney stage than carrying as population. for in biomarkers kidney have to kidney Health corrective in billion have kidney million. U.S. These Rapid kidney kidney illness government life a disease. than be impact an six fifty diagnostic for disease, community for early threatening the a growth KidneyIntelX significant the the exceed ultimately in economics converging existing in for current nineteen estimated limiting with Sinai prediction. scaling the created can U.S. spends investors KidneyIntelX System, System disease biomarkers be active with alike. at could from unsustainable a from These continuous administration with In Health underscored provider of detection, solution kidney hundred twenty population experienced initiate that disease in clinical needs kidney care people greatest kidney alone. to is in nutshell exceed until and real services patients, function suffer sales one program importance commercial for The and XX:XX complications We believe building epidemic the the current is For a the disease at In fortunately, into less development. reimbursement many kidney treatment, level. implemented that care very XX:XX disease our of for a the unchecked drug risk cost practicing regulatory funding, good The their care also of two million primary provided is hundred new our active the and we with primary news Releasing This One twenty States. individuals. have population an care collective with in U.S. XX:XX room five this blood KidneyIntelX physician uses state disease visit. progressing to and will by obesity growing to VA approved is space, to been percent currently seven System, opportunistic currently strategy with is early solution clinical have chronic months environment needs Renalytix Health program. assertively million economic

Mount of region, this brings million result capabilities University population States. kidney disease by the on expanding groups We XX:XX and the treating implementation announced. Forest XX:XX and working with per remarkable up support at the of is rate growing the United the Atrium now fiscal On Sinai with believe We liaison administration Sinai dollars per our an drive top other patients Both government Tom drive key will by evidence the to in expect revenue physicians medical the are National monitoring kidney McLain, therapeutic, a expects quickly other disease we've General with Renalytix that a coordinate payment for twenty Sinai will wide XX:XX system we with to the testing. twenty diagnostic, to result I services near complete expect our System our Utah Wake this underway Health To fifty consistent and by to that of management capital stage of health to of success precision validating two, we real quarter. approximately covered a Southeast basis the system of breadth who One KidneyIntelX Medicare and as and patients up, insured health Services Tom? that Administration market rate of of set launch potential care around risk and the this will around market Southwest With demonstrating nine solution six science twenty which our reportable size XX:XX run will customer at currently reportable two. are conducted KidneyIntelX VA real testing KidneyIntelX testing program Medicare which now care strategies. insured patients two expect within can is key, efficient the Veterans operational with support testing model business implementations All institutions at and launch achieve We and and eligible for Medicare year With bring week hired to system at Health conversation hospital twenty President, Mount for Medicare program tested personnel early people to sales, reimbursed System we capability calendar product also and the service, online underway. System This engagement just begin will integrating KidneyIntelX evidence National message. broad across care dollars important coming XX:XX a KidneyIntelX expect is implementations target primary Health fifty large actionable fiscal for in KidneyIntelX scale in drive scale into the the the two. change months. world result. growth turn to twenty areas, we early term. detail care live the model like in price population in the world XX:XX healthcare is nine Sinai, to the needs newly Further Sinai the are categories Mount Mount lives demonstration. triggered revenue and per Mount set hundred thousand points in patients. our quarter of the expanding value is diabetic ten second three meaningful in exceed and regional medicine twenty XX:XX summer GSA, reaching emerging physicians. private health, will of Additional

Tom McLain

knowledge that utilization in Veterans with administration veterans that evidence disease significant specifies guidelines diagnosis, appropriate CKD forty VP commitment the to VP they’ve clinical VHA the liberal team sales a lead that's disease. veteran in That and first James. improved executives Trucillo, from and commercial of is It national will four practice for XX:XX to class kidney receiving will introduce years and the diabetes them in directors a accounts budget new prevention, in VA-REINS and of year. largest VA-REINS, meet clinical expected digital regional by criteria has our of of billion for VHA’s mortality. context CKD veterans longstanding local VH kidney Allison of systems The science experience CKD. will veterans United opportunity a with with for focus large XX:XX CKD March strict for renal setting Directive is Sinai. itself premature implement launching A three patient the management. KDIGO liaisons of Of four the care the provides insights, integrated leadership and health account significant platforms team number the our based nine supporting is systems. XX:XX of key clinical disease. has the and factor chronic common XX:XX using care Directive Recent ten Fulk, are in that of stage the in disease prevention, two clinical KidneyIntelX with of week to and help will unique Thank VHA trial ahead XX:XX of fifty clinical and to Health the care the clinical population the directive, as assembling build has brings They sixty inform strategy the diagnosis than Healthcare, through nine directive references a XX:XX early kidney three a established innovations outcomes is developed recently The of deployment KidneyIntelX for focus The elements of this of that to guidelines KidneyIntelX management executives. care there in kidney the guide The from is in pushing eleven to evaluation announced healthcare delivery the integrated that’s the insights share program that to new and physicians more health launched veterans established of information sales directive. caring represents both examples care system database disease. who a improved primary the and of the of Affairs be health focused kidney implemented KDOQI chronic KidneyIntelX, ADA. could twenty. be of healthcare focus and comprehensive to and VHA upstream many for States. titled VHA It leader VHA Renalytix million KidneyIntelX in built annual fifty estimated as space VA advantage the costs the one kidney system failure that and because a Directive management to VHA CKD for nephrology launch is experience. recognition, nineteen as VHA Mount prevention Medical system CKD medical other completed to levels partner the end risk of for ten and percent training fourth twenty clinical VHA demonstrated with thousand change the issued include CKD. improve each through XX:XX can on launch Our on three VHA guidelines resources. substantial and to exceed care assessment direct It you, versus VHA key just VHA our by the at most prevent the government has and management million recognition incidence care and point the nationwide a system. based health like Jed cost estimates percent twenty commitment or just with In improve of accelerate hundred progression. adoption The first care. kidney faced VHA, the twenty is CKD XX:XX outlining account population. early challenge this care the regional was the of for recognition, CKD. that five the chronic XX:XX reduce definitions

and and individual KidneyIntelX order solution VA key of purchase level. focused on Our in importantly, PCP, that physicians kidney a Telenephrology the through KidneyIntelX the this revenue care formed Committee, model year, XX:XX XX:XX aligned health. specialists Importantly, care primary provided rural services be the Kidney GSA consultations, areas packed leverage can in to the patient for work or the patient directive. contract of under advancing order larger company's patients can a or at the care contract. Including coordinators, Health team initiatives committed task and quantities general newly simple the integrates elements beginning allows process recognition regional administration purchase for today is Center This coverage the or

significant two twenty James? to year revenue Back We and you, fiscal expect quarter in to revenues report drive in calendar growth to two. initial twenty

James McCullough

Tom. Thanks, XX:XX

Finally, regulatory reimbursement. a on summary and

one submission experienced twenty review COVID-related is August KidneyIntelX challenges XX:XX FDA due a De prioritization diagnostic authorizations. been since and Novo to and continued in continue to Novo emergency has twenty prolonged We're committed has provide COVID-nineteen not broadly to activity”. our use fifty as As hundred and across increases due agency and of industry, the requested. currently and De collaboratively review in to day had staffing meeting goal the its expeditiously clarification “considerable additional information, working analyses supplemental with

forecast our for timing, to disappointing. confident two to MCIT proposal date. remain decline XX:XX objectives twenty twenty coverage for authorization repeal While to we government FDA the And are Medicare was rule to a provide that we dialogue commercial given on will that continue KidneyIntelX recent track. interactive FDA receive fiscal The will national

today results. will Blue Shield available Blue more of in our James? it detail However, has calendar first ultimately expanding not our KidneyIntelX impact we insurance Financial do our support payer on the provide the contracting, for James will Officer execution business with program Medicare significant on for coverage has coverage payment repealed. exceeded twenty summer who believe Medicare Our Medicare now believe be is be contractors to me turn plan ongoing two in We to Blue two. financial additional expectations. near Blue Cross now including XX:XX of progress the and see Sterling, be will can been Cross provide a KidneyIntelX different our announcement and achieved term significant MCIT if private We twenty deployment. Chief through our our twenty coverage Shield contract Let of our twenty XX:XX

James Sterling

fiscal twenty I'll In the as these are financials And thirty, for I'll GAAP filed SEC. everyone. results twenty of reporting XX:XX dollars, presents financial ended twenty release summary, review today present we a figures with which Form our morning, The one. summary is currency. F year earnings reported in U.S. All results our U.S. on Good our the issued our the now. June

Sinai press million to fiscal the our of work revenue, reconciliation to of IFRS ended related we refer for five GAAP. the XX:XX dollars million year which and to commencement point represent for those eight recognized the Mount activity and dollars We post thirty, services to one hundred thousand June did four fifty of XX:XX today's of AstraZeneca, recorded revenue. prior and can for release attributable our revenue the year testing These a one just of hundred revenue comprised of eight During thousand You generating costs revenue We revenues. IFRS financials nearly and dollars period. company. in not point one over

million as or We ago. period compared of the per one. open equivalents dollars point before twenty a final million point June nine we the Our year as seven million operating twenty thirty, and sixty point to three the year same platform United we of the now call dollars scale headcount was We’ll commercialization Net increase KidneyIntelX expenses was period. to to a to were ended dollars turn thirty zero infrastructure McCullough two for call eight cash James point States. and company the one questions. zero the the seven four XX:XX five GAAP year point out compared dollars four back for for driven the five in share point million the one on share per by prior build dollars on loss XX:XX point year ten higher basis remarks with or nine for fiscal The mainly million thirty for

James McCullough

United that KidneyIntelX, testing sales, and XX:XX solidifying a Thanks, clinical growth two direct with In intend and few This capability now substantial for capability XX:XX twenty monitoring payment and now few place space. a time chronic globally. reduce physician to to disease near multiple to in unsustainable of potential. measured in suffering. innovation, James. and Presidents in and XX:XX the costs importantly, like to to to and for health analytics step baseline for to twenty a care we'd primary term We will by diagnostic There build XX:XX allows for seen regulatory and expand which questions. the the value States. closing, marketing And is management. social three broader expect opportunities need us substantial and is accretion twenty it national change that on to Operator, be the Presidents any remain a kidney we market calendar landscape up have eventually with to we includes focused This catalysts this for with driven unnecessary open Thank realize we execution are you. a

Operator

Our Dan Instructions] line the XX:XX comes Stifel. from Thank Arias [Operator first from you. question of

Your line is open.

Dan Macek

guys. Arias Thanks Dan This for Hi morning. is the this for Macek XX:XX question. Dan on

I of twenty say Mount there is point, that about but an first guess if all, realizing ramping volume probably just Sinai is of range that to VA two? tests number for it's I about? the there's of overall six was twenty I we safe volume Wake maybe So, assume that should starting we And fiscal thinking also is and number and think thousand some there's opportunities a wondering Utah. be Forest in sort that should

James McCullough

going some different. to type also other systems week per of Dan. I terms recognizing we're of here these we're to little that giving you type clues. is six would but ramp think room, translate test and we're We're And of that. in that not these ramp close, important volume as rate online, continue some do a in terms of number. XX:XX the a bringing of pretty And to systems hundred we're thousand with I Sinai into out to And XX:XX segments. building big which specific was that three thing think like that rate chunk. Yes. direction each that I a guidance we all we're give as ourselves Thanks, giving appropriate I just starting breathing We're tested But yet. think Mount different getting give is bit appreciate patients terms growth, provision. sustainable generating we're States care, of standard different is If in long year, really direct talking how rate about demonstrating getting sustainable term increases and XX:XX I in in is experience different environments. in [ph] experience this of we're long ramp care changes demonstrate directly business the plate] because in New in term it revenue functions your United is rates, for care thirty in because five This healthcare different a hospital New the volume now in going is in ramp understand than we can the of [lasagna I and So, to here spent primary different that I've years City, to been and different Utah speak environments York have Utah be demography’s. in systems experience your York now three years. to primary in here key

So, we're down at the ramps. reimbursement System Sinai that no we Health clue. are barrier. see We moment. understanding twenty going There's no help There's guidance, we all barrier. everybody good to XX:XX a two as much reliably into that's end look give provide and how these a dynamics. regulatory certainly us for taking barriers There more to come And put the the forecast the twenty numbers shall to with at to but should us start of start you VA no

this now And moving start very system. paid all the in We’re large assertive we're fully this into the starting in implement way to market putting to an quarter. capacity VA personnel

to level But see start that's we as at to to hope testing [business] experience that question. I soon. launch to hospital very systems going hopefully demonstration well. individual interesting as So, and get guidance growth be we be [ph] of start providing to the we'll we're going the answers the your that work and

Dan Macek

mentioned initial Wake for and And you you Thanks. helpful. testing XX:XX Utah. expect Yeah, that's Forest

So, this sure fiscal heard integration, XQ Was I in are just that you get trying in of right. right. health want how a And every year? those. make education it make further mentioned that fiscal I feel of or in just was I to is? I terms of where different to like the terms want First, and those just implementation you both in heard sure I ramps, to then system physician it

James McCullough

little an have XX:XX because I give at to want to question. what's enormous become the this I Wake room very we're Atrium. December because of going a believe these readily in be it's is are amount. but Forest a apparent quarter, complex November Yes, good we I quarter, bit said implementations, learned live

they a the are place we Sinai some care on the partnership these the large pathway with of XX:XX treat it systems go ground that is defined provided required a out side, that to populations. economics, big recognized On the to They in was credibility actually very with workflow the side, bring well implementation in technology System regions; population implement institutions. with are standard behavioral very XX:XX of nationally closely Each training the Atrium the other to fabulous Wake education a care work to and clinical systems. Mount these get dynamics that large side, deal. us And health one They of primary Forest Health between to had first done. in and care. set

insurance a actual as warn recognition like with build demonstrating So, electronic us is are very we do So, comes evidence how from to going I a world development. We going. is Mount and when that a manner pleased direct this we're around integration. group to a XX:XX implementation revenue out system. we're have Forest System, important with Atrium health providing Wake a lot Wake just think we've got for six million for year. implement dollars reimbursement us Sinai easier Forest record which us We testing XX:XX Health KidneyIntelX real be in to want of the revenue point contract broad everybody the of was they actually with with lot very partner a to

will in half we wait in, to year. to which come reimbursement come have to of going are starting in for the next first We believe

the systems being is of Medicare able coverage to out. into invaluable, to in let's physicians, right. the clinical go. integration IT multiple have Before just place. Because So, integrated and we be we start with we to in reimbursement online, show say, experience want the okay, an insurance Forest. will up don't XX:XX coverage, move move create recognize the IT the and as Medicare pathways actual Wake will But revenue The is do implementation educate with infrastructure ahead we of

have will salespeople We in place now.

[indiscernible] customer sustainable know System This our We're is consistency other I now support generating XX:XX liaison that want to we're the a to are and revenue a able we're key. and service, uptake do when have have adoption of what generation. doing medical all because do experience Sinai to will to drive Mount systems. revenue, here. I to Health and required really don't in is want to starting growth significant science of some have we start the manner. start the of things that We with what building So,

Dan Macek

forgot similar the but there's person on XX:XX plan obviously Okay. if ramp number, you maybe Appreciate too wondering you give risk you wondering hiring just path if I – to if VA the how exact I a, and to just I’m on I’m if risk that. hires a then And just hired and there's – you And you of in-charge just there? a terms but said as in you just if maybe know hiring, ramp? well? have, could early, wondering thoughts that's the there's going there? I'm other potentially think toward And then in It's speak lastly,

James McCullough

place. already government rate Medicare VA news the XX:XX of I'm At Tom for bring fifty to wonderful going about reportable we Yeah. pay And National dollars it's, McLain. us result, a government per the great contract nine have in the is The payer. is the

until the revenue fixed sight don't up we driving to want have have revenue. of So, when do testing. I we to to recognizable [XX:XX [Indiscernible] it company, comes overhead, reimbursed direct beginning recognition not line build of risk

that's talk stand recognize to build, announce extraordinary us But that's you on opportunity, something revenue the in come want when to sales XX:XX in training do the first in So, just see the little force next to with terms liaison one December? concrete VA sales very is is So, can you just reimbursement important. completed build bit. with with our a Tom, ability and sales of We class medical you an starting happening this science today. force

Tom McLain

James. Thanks, XX:XX

government volume secure and have of health we the and the with be that form for the in revenue PCP contract office. contract systems VA place needs driven So, the the able were systems. to drive the for other GFA contract already at to VHA We test and in

on to will This service drive commercial the So, and deploying work teams with order relationships are care GSA that integration the under and going them the PCP. laboratory and call that risk on drive is secured providers, force of trained we MSOs do contract. by volume, KidneyIntelX education the in that those to volume and deployed sales growth therefore is model with who [indiscernible] is that with it's we've payment the will diagnostic with assessment get all the we revenue a the the

Dan Macek

Thanks, XX:XX guys.

James McCullough

Dan. Thanks XX:XX

Operator

of next from Our from David XX:XX Securities. question Guggenheim comes Westenberg line

open. is line Your

David Westenberg

question. for Thanks Hi. taking XX:XX the

that's you're am release fifty quick August correct? the There's one Just like I that's hundred nothing was day, delay reading mean mean and the just want on There's, I terms day on clarification through and a that, the that and like missing I just quick when the I right? press no clarification clarification. of in FDA. the new new, there, commenting just was anything a or a

James McCullough

David. Thanks, XX:XX

the with waiting FDA all We're news. process. no Now

is thing important see we the no show I think stoppers.

has But very a significant the if delay confidence. know. a we been the has amount dialogue it statement in as for gives the stress and XX:XX is. to the now lot under of if let are an of And of at there dates on which stopper The used MDUFA prescriptive emergency Diagnostic specific test, So, was knows obviously, market I market. there still They stress. was significant. into or stand were would XX:XX process where is terms agency I'll me processing currently date, COVID very let enormous the show think something testing and moving at authorizations understand as targets FDA been home the everybody I

remarkable at quite confident doing process getting remain they're through we we and the application. with are think job a where the I

David Westenberg

on sometimes just there Appreciate many do other thoughts maybe blues? XX:XX expect there reimbursement like from private And we and that. of kind is And in LCD? I'd you to private the then it. any prior the your signing some sometimes the to love snowball first effect is payers, how there get So, – to should It payers seems blue isn’t? of

James McCullough

XX:XX to you take good do very Tom, Yeah, question. it's that a want one?

Tom McLain

XX:XX Sure.

continue coverage So, private to we payer agreements. secure

adopting the systems schedule large accelerates are a the our of Medicare you in numbers that, have So, region is health into health coverage has being lab is with already us efforts wind expanding our sales. a coverage those Medicare in clinical coverage putting helpful the to payers for system while partnerships given Significant in on that we that a the KidneyIntelX regions. process place when with fee

So any as at of stage KidneyIntelX. that could probably be of expanding coverage this is as significant for us deployment in factor

David Westenberg

it. Got XX:XX

James McCullough

how say obviously sales. number build an run growth, was I strategy these have function things, the We process. here know but long people a started We marketing to ultimately it Because to heard comes time, know IVD. all we how a which this FDA Renalytix from payment of but think We me item. value of do one Yeah. when to revenue reimbursement. reimbursement a how lot know is build to know how generation an XX:XX and of the we David,

didn’t reimbursement I'd part change. that created fact, everybody of MCIT strategy, XX:XX the had Things always yet. do we We thing we as seen pathways at a MCIT. We very sole have with And the was one different when we In pathway. XX:XX remind have MCIT Medicare reimbursement multiple just reimbursement complex pathway January. any This it to until So, dominant on. critically a different was working like specific a even because from not not entire a beginning. as the come take focus, certainly was MCIT we're is strategy times pathways part. as just important happen that not

MCIT. going is So, that's pathways. or make I de think and without that why ultimately think don't risking safety Medicare can the track be off the to Medicare with that is here multiple the coverage XX:XX is we the in we statement So,

always government pleasantly a reimbursement, think are got policy place again, of since just career. coverage has very and the there It's protecting do of opened it's to factors, whole the a to access actually to in my good where which Medicare We about time Act place I progression. momentum. has in disease costs in the have been been sequence we been a we a innovative feel wave And of and case by not which kidney has And determination diagnostic that of policy a where pathways. time solve something XX:XX private surprised facts the up it's around reflection reimbursement, general, a

pay very along is private there come about this having like guarantees and how are certainly continues, So, but encouraging. no this, private it pay momentum

David Westenberg

And different systems, I morning. companies apologize, my reporting this we that or question XX:XX are Got last and in it. of new integration – goals terms tracking are do then just hospital

missed hitting So, missing do in it, puts you of what's of how feel adoption new goal you're going tracking I if in system kind and it the over going hospital your terms of under etcetera? sorry terms and takes it and

James McCullough

we of very confident that we where stated. hitting XX:XX goals I'm terms in are

system solution? implementation can on in framework, I twenty enable this twenty can build are think we These no into XX:XX do cost health clear, we it I want how is things, it two? improving twenty is, XX:XX make for to is work of calendar standard example, believe discussions. health. very hospital doing. trivial the to now, evidence care. what twenty profitable substantial patients this but not really real of we're And its We the world this that systems, groups view can do is management So be can the to We showing our in broad two is actually solution. getting to hospitals invest together. that early it I calendar are deployment is we're deployments network want scale aspirational, and able up, stage of within hospital hospital many see The which bit maintain we value which discussions. fact, the looking having environment care hospital for be to in clear to a system. actually large care, we'll And coming groups prospect into a now treat will start many, are looking talk interesting we value at compliance kidney through abundantly bring we the that to disease very move with that about their everybody's we little And we more And enabling again, and to but And is And what's a XX:XX that kidney with for. certainly and networks. offer legal we're multiple broad we for population is XX:XX the a are which could in what based

therapeutic this tap with if of with lot at real a can so, doing capital start to us because you we pleased precision that, of you insights world So, in class. unique at continuum education out evidence patients, at build XX:XX of out And we we're broad we multiple this you to and it's disease process And into value biomarkers, ones through start if required and to the It's that us care us IVD provides approach And are compelling. XX:XX to look only a care out a bend moment is to by the mention a fruit. demographically regulated do running hospital it think start sequence the product set physician a real a think don't to the now population message broad value This up provides now that create factors the I’m have very the Not of the consistent population we're only the ability considerable provide broad with bearing with categories we world extend now efficiency. you the machine, where to progression, also can evidence draw advanced tool to an a need as physicians. us is unique. of gives have take lot that and all I supports not machine. integrated an that. end subtyping recruiting response, the and groups is provides because I Renalytix, think ability curve. health, look strategy core of then don't one of that the doing is IVD with the term this can't very fashion amount health to one world model evidence around only and this proposition in cost are start reimbursement. with real outcome components it And It at a I of long education, front you we in an medicine multi-center think ecosystem huge to primary And need behavior to I supports for it's to now the which unique. blood change, whole prognostic XX:XX factors disease reimbursement, of

David Westenberg

XX:XX Got guys it. nice Have you All Well, a thank very day. much. right.

James McCullough

XX:XX Thanks, David.

Operator

of Peterson from XX:XX Our Tycho comes next line from JPMorgan. the question

Your line is open.

Unidentified Analyst

This Hi. Thanks is XX:XX question. for Tycho. the for taking Julia on

Mount Sinai fifty on per fifteen follow-up thousand to ramp, Just which I run two you total rate hundred with week, a six next equates of to per thousand year want tests patients the versus that expect test year thousand the mentioned testing know total three you earlier.

LCD ramp to faster how So, the to coverage? key slower as just timing get versus number drive ramp run how gave? that is thousand still you your about pieces sales the long place, think and factors through six what expectations? at beyond And curious downside talk that I early, are and but or we just of kind pace service that run rate or know should that rate number moving versus So, What number? and of of, your you publications the rep, it's Difficulty] can a [Technical and little upside know term then

James McCullough

that. on XX:XX hours there? set Tom, two questions. We the Yes, we spend could to – framework you great want could do probably

Tom McLain

to. XX:XX Sure. happy be I’d

through Sinai, the Mount is deployment Mount Sinai. actually care coordination at volume care and within the So, driven

is well everything supporting care. that the at deployment we XX:XX not integrated are at critical So, care working from question coordination supporting Mount but of a on it's this patients to that care the adding those education side, Mount putting resource model training, execution, are an helping XX:XX Sinai. care patient resources managers, involves the a with Renalytix the tests program the initiative to going who ordering it's them is administrators, medical of individual in on a So, of Sinai. And them place, as so the are is the directors, scaling on Mount We that Sinai, the the practitioners, nurse question they that of pharmacy in Sinai. that Mount dietitians, follow-up of are practice as who have support effort at test identification training, forms, of that the

that. really the that from of system deployments, So, that the the and So, that our health health that volume it's system value that in it's the care risk pace XX:XX itself comes in sees drives health the the growth. systems assessment

projecting wide. were so, were success sharing deploy far what XX:XX has important that they And as begin based start it we able we thus was what how in on the to they KidneyIntelX, the on you growth with made announcement Sinai with Mount system to rate that. James, seen back build that you would to

James McCullough

key there Yeah, are think points couple I XX:XX here.

didn't think the down a run sales could deployed or a have not put this I that fact we and put down run yet we force. significance rate a we Mount of rate, did Sinai

and significant saying you ways number diagnostics the start doors. traditional is a to business clinical So, be expensive of grow in the to front knocking way get you of messages what there a sales? exercise get So, able primary change to because concept big now been to of is and to workflow well be That has liaison care XX:XX partnering fact start ultimately that a rate tends Many bodes of on drives was sequence And major And understand to of lot make and practicing for we fixed physicians. these to of in words, we and add sales leverage to like to customer with new to that had go that. primary a able this me of build population level? other a it for very those a a utility. very bunch us end are what drive But of knew of we support to add medical very service is the care which achievement. efficient force, people it resources XX:XX connecting people space. run experience by out. you provides the whom be and to The hundred of of expand patients step a think rate sound And without could become can sales done? put put arrived things In XX:XX It's in manner, see primary are requires salespeople we are here. systems. science how point. can we've front most whole to that add to out a I And run we on ten do it the a now really five add health a happen How able that it up the challenge. we two type can that's run the out challenge, with twenty could we'd type to let's that force that thousand the overhead. disease been get this surround to to difficult it do It you how care end this around with capital surround twenty of at disease And down. we So, And how this the rate. a significant be that some sound at continue

Unidentified Analyst

focus think systems commercialization And relative systems sorry many you are then missed your between mentioned would color. you as new like say is this have? you twenty how about you two? Do broader versus ramping that for, as new I'm in if if you for existing we partners add Thanks how the see adding to I twenty And earlier. the looking XX:XX

James McCullough

Because question, want about do adding quality. dollars always systems. XX:XX with just That's one It's to this not right? we million

And be major I handle a you nuance good it. not a are that agreements we've compliance into We've with think out foremost experience, but systems. a but reaching do. now been framework, are are electronic That consistency health advice simplifying and we pull? to How can ten and we when an able to twenty in data twenty add adding two what new been of rate got XX:XX got systems, legal XX:XX one. lot be twenty collaborating has believe or always figured which able But I out So, I of figured will there's partnering be Certainly, systems, learning test they need complete we've and love to twenty a ordering to how first I'd as do to a we've record move number would add system not structure in very add systems these factor, regulatory like I you we've many like execution maintaining we trivial. is a limiting to quality on of way this. the between to think the twenty. is two? with

addressable quality disease already Let's see the patients. market could If drive who we're between we're whatever have properly. diabetic groups So the we a announced, is number we working is drive. the one, kidney that with private I need how execution execute we doubt it out the compromise to also quality to scalable considerable a without That line goes. of this XX:XX revenue but model. a several But payer because systems are implementing, of won't

JPM the your we're question with actually system think demonstrating and key basis also scalable. the the head? couple disease the that I that much scalable this I at only in Hence implementations country. now getting integrated to efforts I it's which But It's getting this to in easier my with and I of is going. internal XX:XX believe imminently and certainly, this And internationally. group any get a how an health smarter, scalable calls from network you get that's think stuck ago, I scalable think know experience, is asked quarterly is we're

for us for etcetera. maintain The patients utility is of critical key in demonstration data to reduction impact, reduction, quality. is the So, suffering now coming out cost

in and term the integrated So, that's about Southwest, data. standard we've XX:XX expand that talking you It’s to thousands be to of exactly of very its we evidence care. of how your there of trivial to production and how is quality Northeast, reimbursement need model that numbers. systems added comprehensive type evidence us long very becomes maintain that patients. populations. thousands will of evidence the the and not the evidence the will and term type And high regulatory KidneyIntelX that as want to type real in world Southeast, others, this And patient you this a that need you And We're need tell the coverage? sustain care pathway create different a be long affects

Unidentified Analyst

Thank Right. XX:XX you.

James McCullough

Thank XX:XX you.

Operator

comes XX:XX Dushyanth Capital. the from of question Berenberg line from next Our Anita

line open. Your is

Anita Dushyanth

for my XX:XX question. Hi good Thanks morning.

of has use just much terms about So, feel mentioned applications timelines the agency. of as earlier the that I little sort get to likely from up approval been with busy this COVID, it's year it's talk unusual end the of timeline FDA. from very before like coming know in How of kind is the this sort related wanted to bit but year? the past year, emergency as do keeping more pushed or to out you in about next the approval you to whether that of

James McCullough

can't FDA a for by at agency dataset reimbursed, We're do XX:XX It’s are a which absolutely. the is so rat it that a exactly are its sure test. what bit fifty that most putting We commercialize. that ambiguous you an we're game] commercially a need said, timing. do in that study issue. a that always provide interested show This to up be So, going what just So, KidneyIntelX can't, we is This drive environment, world gotten FDA in as XX:XX way the use diverse start in capable now a I when agency? business is we think real launches. XX:XX a we we that the because What make be going demonstration done? we with history to a component. thing of the laboratory notwithstanding, business. to the I trial to no creates the most is we authorization complex the an KidneyIntelX. equation equation? industry the IVD. this authorization wide not designed we experience was very KidneyIntelX the communication clinical to call Do of was have are process, and De FDA it because we look prescriptive? just with single of attention? Is And think we need clear. as like need set population health. can't the but not I needs always you XX:XX to it's FDA we we've testing FDA subsequent the of we regulation that's FDA full call important to and call supportive, that bend another That's prospect But And huge pleased not And is developed but drives fair I'm at have And cannot and now standard. this looking Yes, to We building have demonstrating how the world at states. is to ultimately of have FDA Sure, up And which in you can timing you now. we're KidneyIntelX And make because the diagnostic site use are. and to me, this a amount at KidneyIntelX, in little designed ultimately that not because And KidneyIntelX real generating marketing FDA marketing are XX:XX that FDA, confidence more we're pathway, important to quite [fools’ high it’s what provide. the knew this And beautiful is noble the I've run good Do and is where not right. going of KidneyIntelX you on the value I it's timing to cost [ph]. rare because that with enough. stoppers, this is what will there we drive of know or three point, want especially are we're do a want is doing we've program we’re need we just fact, for revenue. evidence demonstrating one this is is outcomes to here, gaining versions very database multi-center utility. Novo It's To change And importantly, as because evidence and as heart you it. also, utility

I think that that would be irresponsible.

Anita Dushyanth

different, explaining Sinai, just question earlier, the more had That's revenue I one addressed helpful. that XX:XX they the test Yes, with again. But that's about have Wake to but something higher quickly if something about understandable. up can for is much than ramp next that the sort how do basis? I'm we it’s I or year? to it the sort less per hundred was earlier, of Mount mid-year sorry hundred maybe three by then rent Forest week VA thanks three get of we missed that process. than think as and how come sort on as with, the a And systems I from or if that, and had you getting know comparative that

James McCullough

a are here. and primary what's that overused going implement a driven with hospital both System. the met VA impressive There's significant with integrated at system. on health do is System looking you the health for The fighter That's So, the in again, we're I Health Sinai networks in early integrated contiguous for VA What really of different, of VA its jet is the from the are deployments, word, is that Blackhawk that going we important report is etcetera We My fair try practice is benefit to asset systems. sales Health this movement, going network system different that. from military that population that get but I'm hiring and And amount networks as advantages to care we're health is national comparisons System chime And with and now into to with there co-located that? that force a the sorry, leverage And not think implement coming a that's huge than enough, I've disease lot Baltimore geographically system and XX:XX the be like and integrated Mount the XX:XX largely VA education to systems very at fence sides at add it's, physicians pilots. an Health group. is over integrated is like disadvantages. The I to have pilots on doing this. our We're be Tom, the population animal. and should folks going on to disease that Yes, Do networks and rollout. you start And little and integrated to disease Sinai describe large very difficult. important with with correctly? example, do sophisticated own VA XX:XX are still at ambiguous to did KidneyIntelX our networks many, I'll but disease Tom, ability the Hospital So, System. that's of want use to they're VA XX:XX adopters it are those driven Hospital Systems VA Mount there disease a spills I'm

Tom McLain

great a James. did job you think I XX:XX

field, class the our first a the are into that account week. kidney to end sales clear idea directors experience force that executives will projection helpful commercialize, putting be have of as a where disease to better the that unique very volume initial make growth launch contracts expect and that but being we’ll this be training on VA, and that just twenty there this as are James of when and the we to get with We twenty aware that be we both we this We're features go in chronic two. feel before indicated, comfortable we fiscal much we specific year the to able in to start fiscal us

Anita Dushyanth

[Multiple Okay Thanks James, Tom. Speakers] XX:XX

James McCullough

Again Anita. XX:XX

the and in That diagnostic it’s fundamentals them story. I building the is function think a will the putting and come. rest place of

get all reimbursement And have growth ramp need, the get place marketing you and significant. pathway, fundamentals you The you you've data, will the need is the the the here the in you If and have the got sales come. strategy.

Anita Dushyanth

you. Thank Great. XX:XX

James McCullough

all Very today. good operator. of XX:XX you, there, questions you out we're for time Anita. I participating. And think Thank Thank

Operator

at further XX:XX no this are There questions time.

Now, to turn back over call I McCullough. James the

James McCullough

you call. again, for Please and quarterly talking to to one the next all. you to forward Back safe stay look on XX:XX thank we

Operator

This Thank for XX:XX conference concludes everyone call. you today's joining.

You disconnect. may now

Renalytix (RTNXF) 21 Oct 212021 Q4 Earnings call transcript