RENX.L - Earnings call transcript Q4 2022

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Operator

Good morning and welcome to the Renalytix Conference Call to review Fourth Quarter and Full Year Fiscal 2022 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.

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.

Peter DeNardo

thank for and call. in Michelle you, you participating all today’s Thank

and Financial me James Michael McLain, Officer; are from Donovan, Sterling, Chief Medical Joining Renalytix Tom McCullough, today Officer. Executive Officer; Chief James Chief President;

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

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

James McCullough

tool disease generate comprehensive kidney Good and in and early Peter. funding XXXX afternoon. first are care. patient prognostic change In wins have significant opportunity these had widening both categories our data Renalytix From you Thank evidence KidneyIntelX. which real in assessment risk for market advanced was to our grow built of reimbursement good morning with drive and to expensive November in share the we

are the will Tom in by XX SEC third KidneyIntelX Cross McLain and billings state now have our paid being Medicare filing We system. in Medicare insurance beneficiaries. United States Shield to week, the was about million now payment and speak Blue detail last expanded coverage covers shortly. our as the Blue approximately in

in a disease, KidneyIntelX of level this Costs will a with diabetes of dialysis. today. develop their greater opportunity quickly. critical the care centers in at on form in for have Medicare of the problem medicine. year coverage insurance To KidneyIntelX of primary diabetes half American health here costs kidney estimated adults a feature in reaching sheer end where put to XX existing Over disease. are have a will for the individuals perspective, of over the of and and of pile kidney October some Medical is than some tipping Association size front payment point million prevalence with We are or population up supermajority, implementation Journal certain dialysis An large kidney testing. first XX% Supermajority report disease XX,XXX Americans alone citing at

unfortunately, suffering is raging patients insured in failure This inequity large disadvantaged privately this close first from has with individuals unsustainable. are portion center of communities. course States costing And a of disease the a United are kidney economically preventable disastrous $XXX,XXX groups. simply from consequences to year become health alone. While Kidney in for their of

showing to first are Medical In management outcomes. Chief given In of changes XXth being are September the progressive has conduct data new one from specialists, week. pressure dialysis. been important KidneyIntelX their initiate using doctors in event XXXX at quarter likely our alone on Donovan And and much prescribe million-dollar prevent period controls Our which positive shows and Officer consequences presentations week will Kidney referrals new our of just posted medicines early, next being evidence summarize Michael quarter. disease patients real-world and ended this Nephrology four now patients suffering Society patient accepted for we to the of programs American publication the published blood kidney to timely more

see beginning payment a has individual encouraged For disparate been now groups sources states reports recorded in located from testing the including we record alone, insurance where continue month-to-month emerge patient established. we And month physician XXX KidneyIntelX issued. different while of to are will results volume vary, September to to

no kidney with on to have recently further diabetic with use to analytical the and high process is until the has there and FDA. have de the discussions had confirms approaching we we are its We success discrimination for KidneyIntelX performance FDA engagement clinical productive the device year are of to of review, now, that with disease. evidence optimistic fortunate We additional both and under guarantee X,XXX believe determination, on our while and novo level continue have FDA provided the made we based this quality patients data final of over we risk submit regulatory the patients of of past breakthrough completion been the

builds current time reduce March, we supermajority Our this first calendar be be focusing regional KidneyIntelX a no have Also ending with the on expectations there are guarantee been as developing markets decision made able to XXXX could insurance burn our in for quarter on of cash by clarity to for frame. payment. but

where insurance in Tom call will commercial product will November from progress over Renalytix major third and headcount financing year rate four our selective integrations. with commercial just who our turn of continues of from could reductions, market and and the now is business party as getting McLain, short out. two, risk approvals, utility mitigated cannot of here payment, in position validation I roll objectives progress be we its achieving the very a our We a conditions, of time, have and we period for a If have well of KidneyIntelX. XXXX to with President, contracts, And round in roller made detail also coming we that founding short milestones regulatory in nothing or slowed and insurance Tom. a been coaster forget while very hospital reduced our vendor years quarter launch. our over expected, it's

Thomas McLain

laboratory with other also Thank that The maintaining environment. testing significant a the laboratory are James. and payers. and you, and progress KidneyIntelX for volumes we [ph] testing is KidneyIntelX regulated operations services view providers, making filing increasing are quality coverage high payment From commercial significant to expanding for in necessary healthcare announcing Medicare operate for recent payment for testing patients, with highly

Mount has of real analysis that indicates drawn. experience or the Sinai patient It not been made payment that XX% is in City. population for where the lives Foundation New Health the for the the use System determination through on account KidneyIntelX. patient understand is where important data testing available Our the where validated based of Medicare our in within performed, blood is beneficiaries intended Medicare world XX% is to Family to Kaiser York This

All that is New by beneficiaries across patients So Medicare. Medicare for this Laboratory. testing the performed City York our includes world in KidneyIntelX being are covered

result, have In for we an starting Renalytix. the This on regional for New a eligible determination Medicare determination from performed. covering the makes reviews have claim MAC XXXX. as Contractor payment provided services, service services, for documentation X, July week, the Medicare testing filing This related the issues ICR, paid submitted reviews claims MAC submitted dates to government coverage. York testing, who and to Medical and is of to with to and Review a reasonable or KidneyIntelX payment last based is necessary. to Administrative and SEC Under significant Claim clinical we a Medicare been national Director all KidneyIntelX for XX% extensive the is or testing MAC whether evidence that the claim As XX% have for Medicare Individual we information claims specific the patients each material

Medicare Determination MAC. who this coverage on pressing of Medicare we believe payments. from KidneyIntelX of a payment Coverage Based the also Medicare other in for a volume submitted additional request insurance evidence claims the LCD from on testing increase We rely Local significant for also determinations payers, KidneyIntelX for support will or

it and current been have consider Directors then an our for meeting. the that to draft the published has will to public MAC reviewed claim review. policy application and previously reasonable open is determination complete at accepted process, whether submitted is evidence in individual determine is in We notified coverage a KidneyIntelX and review This necessary. Similar the Medical been LCD the

reviewed. are under the This public continue recommendation until to current notification that date, process MAC completed. quarter early is as now the of March they LCD when XXXX. their the take will meeting pay could awaiting The will of We review meeting has place as ICR indicated the be

with accelerating Cross rolling coverage Shield XXXX. additional and a we contracts Beyond are the and coverage Medicare, secure of insurance fiscal payment expect contracts payers including Blue reviews regional remainder through would on and Blue basis large to

supermajority focus in enabling insurance our commercialization KidneyIntelX testing large with indicated, XX% or coverage greater James markets. payment of is As than on

Turning now to commercialization.

As field XX executives account year for cost part to actions sales our announced reduced XXXX fiscal force XXXX. the we of reduction in

practice, broad and health individual significant sales near Our sales where coverage VA are opportunities is and team on payer is for focused likely. the territories system, term

testing care the out the the quarter. health Health the Mount pathway that care the increases with for care practices indicated services testing to of of System the program and new value being In bringing KidneyIntelX disease patient program driven phlebotomy increased to to optimizing that and As developed established telemedicine. patients care a important has locations Mount the It system. by leverages a rolled in the being are understand Sinai quarter care kidney James by home is across Mount This better is combination Sinai adding Sinai, the by pathway through during testing. September diabetic coordination earlier, through practice use at early-stage of

Officer, the KidneyIntelX volume Medical systems. at health integrated XXXX Sinai, Atrium will Donovan launching results testing Michael from Mount the programs River informed be KidneyIntelX Chief increasing utility compelling Singing or in care discuss influential patients expanding under will System, Joseph's Health. Health, Our and Those drive and clinical the data first similar St. care include This Health will in other receiving positive pathway.

the Administration inside care in in community VA Our provide as Health also. the continued facilities veterans. as well Veterans on We're clinicians for advance also who System center focused clinicians have to efforts

for Network Veterans and CCN providers to approaches its receive manage a potential. network to provides and VA the to guidelines between full administer ensure Care the high community VACCN industry timely the services and Community veterans care. link uses direct pay standard quality Specifically, promptly, services, Administration or

on into the scalable During success, volumes United September this introduced highly we testing regions initial KidneyIntelX we in increase in two expect December Based States. This and that and five year. VACCN is November October, a to of the see of program.

In addition, West agreements the we and have the the VA Southeast. executed the with purchase in centers and in first blanket first test quarter

on Building orders secured and we at agreements testing are for center. task in third addition, laboratory prepayment we In initial stage a in successes, these services the other development locations. for a VA

agreements up year. expect next eight more We to VA through with centers June of

task to care and clinical who center. the Building offered before a center home agreements developed center our under on on from VA can testing increase contract basis an at commitments program accessing the a Mount modest, testing to patient Sinai, experience commitments. of are initial the be other at that also access designed to have evidence we've purchase KidneyIntelX or issues are to veterans for programs and value increasing adoption by generate order mobility them preventing following by those While

XX higher of for the kidney Health University will opportunity based in University Demographic XXXX. to accomplish, population. Health While in the the the diabetes the economic disease these conducted remains published with months by a and on being VA and taken strong chronic of System VA be initial this from have of wins study and data Chicago the Utah Illinois, incidence

and significant This in executives also on percentage starting focus accounts beneficiaries. this sales opened field Medicare our Under physician primary through meeting quarter, endocrinology are care we account their criteria; patients up two the a of late testing reps are introducing local first, a to market program, our August.

diabetic Second, new there to innovative kidney is approaches therapeutic demonstrated adoption treat of disease.

year. and fiscal account through to Between increase is contribute systems, see a sales, end targeting will ROI test primary in positive every volumes care VA, during our quarter direct the and territory health of expect we account physician and executive value XXXX we current every current the to year. the in Our already expect demonstrating

Finally, series external demonstrate of CAP, rigorous positive certifications compliance by That fiscal been audits year and XXXX. internal the with company FDA. and the a CLIA, evidenced has for during under performance continues regulatory are and laboratory standards ISO, required its that to testing

quality client discussion delivering clinical Donovan, important patients. in review to teams laboratory supporting I'd to the Our data test increases who over will Michael. Michael reports volume prioritize and turn to services samples and payment. to continue and utility clinicians processing the like test new and

Michael J. Donovan

Thank you so much, Tom.

care primary their managing with patients on to document continue and diabetes decision by kidney we world disease. of making physicians impact KidneyIntelX So real

important function progression stage future management like observed behavioral kidney evidence, the role for care increase therapies the on KidneyIntelX action is high the of more encounter specialty in following month patients. over such we of observations our had patients their the importantly, high referrals one first adjustment which of a may for months level the form managing evidence SGLT-X assessments their every believe care, new change should investigation at in risk primary decline KidneyIntelX risk and primary six of of one XX patterns disease. tests, with coming were novel at part basis over high look the world for the the their KidneyIntelX doctor of a the by of a months. taken a effective changes current with had increase a through in of based the least month early patients As ordering development KidneyIntelX for six use XX% physician, a evaluated predominantly is real Ongoing two-and-a-half-fold repeated time high care modification management XXXX clinical what risk in months. four-and-a-half-fold continue kidney recently in specialty ongoing We patient's the standard and compared groups risk patients this medication. by risk Most patients consult Three care. identified XX% or at a inhibitors point to of the with as its risk as in services as in of would services programs such observed to within reinforce

XX% also third of observed Importantly, cohort were the of KidneyIntelX. XXX the the black as were XX% or high than high XX% more representing XXX patients, as risk only cohort population that patients a comparison, the of representing by classified patient white risk. total By total the we identified

eGFR including change of trends on received and Finally, pressure in of term approaching early longer this our the reductions have blood James. improvement strata in six in our kidney Sterling, and values UACR ongoing, study, patients Officer with levels observe loss testing. XX and slope, along to recommended UACR in at who associated although months’ HBAXC anticipated collection call XX based reductions is outcomes and risk in course KidneyIntelX still in the Chief Data the we management post review across of some a over did at for turn weight financial targets Financial months. with now James function I'll results.

O. James Sterling

June filed on reporting our financials accounting. U.S. morning. and GAAP under based the in for Good which results and fiscal currency. I be Report in financials in XX-F we our our Figures Form are here IFRS Michael. will Today subsequently detailed issued discuss XX, year which our quoted Annual Thanks, today financial dollars, on is later GAAP XXXX will ended our

XXXX we year to revenue fiscal on to from XXXX for million million reported year XXXX total higher million million and for well Operating approximately an recorded expenses services KidneyIntelX the R&D loss just in XX.X the support as XXXX of professional million fund fiscal For testing as This remainder million, which or almost basis, Net revenue. of was from headcounts from growth. $XX.X X.X X up studies, which increase to XXX,XXX was X.X primarily due was from for share. testing, of was with being consulting a per XX.X our higher and $X.XX fiscal expense increased were GAAP fees revenue.

equivalents is loss fair the previously we XX.X convertible amount per reversal adjustment. XXXX. basis bonds amortizing year to June year loss XXXX. taking $X.XX into in a convertible of of diluted ended in million the a conversion senior bonds, cash fully bonds fiscal net of with and or Net principal $XX.X of $X.XX the XXXX. of with as of in due We This shares issued share, of the a April share per value account As reported, XXXX April million, was $XX.X XX, and possible compared million on cash

are quarters reduction we ending to in more that half on million burn anticipate in The up in reduce Operator, As in We revenue, extend second with call further adequate process. and full our should, yield savings into fiscal us XXXX. realized annual had cash runway to effects to runway. December for be we provide the March respectively. $XX cash this and assumed steps now could that an our we of expected fiscal third over and we've rate first fiscal XXXX in mid-August, And a cash achieving disclosed designed reminder, executed certain expenditures taken questions? since of the depending with changes open

Operator

[Operator Instructions].

Our from Stifel. Dan first Arias comes with question

Your now line open. is

Daniel Arias

you. morning, good guys. Hi, Thank

volumes Just around the week. XXX is wanted quarter, during which test on a to XXXX start right

sort there you generation I most or data going what clinical helpful going and much slightly Mount from portal tied within James and etc., how it on level? be where get logistics you to commercial versus infrastructure, to ramp Forest, doc EMR to need expect think just you would here testing talk can last just just and like reimbursement if are be the quarter. Utah are volume established that up what and Tom, the Sinai, more then dependent of things awareness, that Wake that's trying a to and it understand those points to you're of from and get trigger at actually practice to things higher is

James McCullough

thanks to pickup establishing think it's course, becoming issue. We better do. less are Dan. give of is at I'll obviously certainly point And most and issue to and more an this and Yeah, important I we then thing a as education a seeing And the in what Tom. comprehensive of turn better reimbursement. technical get we single that of answer at volume quick a much then, over

widen on we experience authorization, well. and to de the Tom, got marketing an with obviously, that Medicare think, especially that volume a comes going are tip to pretty if be you help we going that's want reimbursement. the down two to things see FDA novo up we're start support belt implement I to too? into market, and much under year this But over know really now for end Shield education and to Cross So going have start an Blue next support increase. on at that's and obviously, major up to pathway, how and enough take help point, now when our do additional plans, we Blue it Those as to to going that

Thomas McLain

for a testing echo able only data adoption broadening the last you are what is physician both and and focus said Medicare for the to And utility benefit that's of understanding would importantly, I accomplish and over of strong Coverage intended primary increasing important because population described forthcoming very here. them those Michael and coverage volumes. the data, going us to use James. how of year significance their important can have and on publication benefit the be and we KidneyIntelX for care And been the patients. what utility been have very to building

Daniel Arias

that will would that being when you was I the testing XXX Okay, hit position think just centers, test XX are the XXX up Mount in testing end I a update set of think those in be within eight health targets? James, follow-up be to per And the might week was Sinai. do in still on by of question, you calendar the guess comment then there, the quarter plus last of begin and what's year? you thinking VA,

James McCullough

Mount Yeah, XXXX [ph] piece Sinai calendar.

into also payment. prognosis, push late January especially patient start the should to model population And that, cost we stage additional and their some on interest for specifics, the to coverage, get diagnosis, progress very securing comprehensive real are And to do be And start best into to supermajority in sudden quite full private insurance actually patient part going in January help. pointing than next to making disease starting productive, a payer payer of to dialysis to where population as that's without for now So of with a larger we believe, you expand year commercial payer City, shift into and a we that's public we start But Sinai. you groups now New all a to take bill. treatment mix. have especially moving get which of and going influence can in plate York a where much a a York State, rather that and bit is position in payer that of now we're again lasagna New groups

looking a specialty We're the patient in pulling practices, practices, push different testing a there. So should we accrue across that disease an at specialties disease, cardiology, of got primary of board, gateway even vested And is demographics. the towards understanding volume management. including which increase expect interest is, of all outside care in the everybody's do what chronic lot a kidney the kidney state in to

should XXXX quite year. actually very interesting So be a

Daniel Arias

one given burn I'll cash side, to then today, the off, the access where me just how obvious think you headed, capital last hop go where the for thinking and far cost Okay, is is before maybe this on point? OJ at and should just the you out we that need one structure

O. James Sterling

comfortable been the we are or into XXXX. we've least saying So in shape to get of at half fiscal through first

So indicated already it with the that, indeed we've we we of that good us. year to XX reduced already and million today spend, spend. cash done annualized. to we've to already more north And flexibility of expenses Pretty reiterate flex available tune a

cash about to at event. milestones expect and in through next some funding pretty fiscal of feel so good I us finding position a point the or get would there And operational XXXX, abouts

Daniel Arias

you thank guys. Okay,

Operator

question. next for by stand our Please

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

Your line is open. now

Yi Chen

what taking you Thank on of volume would your fiscal the quarter you be target for XXXX? my Could end comment questions. by

O. James Sterling

Yi, Thanks the question. appreciate

Advantage real it and area forecast hard, point I BlueCross especially So we dip supermajority start we to be significantly in And for where us population. into diabetes importantly, tipping Medicare my again, of private to BlueShield, Once Medicare, head, coverage. have comment plans Medicaid, think in other too is don't the are the you than the want but today. of higher will the

an to that aggressively equation, becomes etcetera, in on are to about of specific larger to many education, we who now which you're ROI KidneyIntelX to areas the put terms patients ability Now bases. eligible majority for of test and want feet patient vast to the is, want the get at do go partnership, we how street talking how

And this said I patients risk of in thousands publications rat reimbursement with showing the the just ourselves but study, work. that into that's and in a the expand we my of statement term KidneyIntelX in scale going could certain that two not quarter, group really in patients move completed us substantially to risk to now a to KidneyIntelX for find to regulatory broad having get across allow does business density well paid. coming And but that and case assertively into the assurance short believe that high model, more substantially use. pretty a very have -- up So we an mitigated equation, March will broader we're now business much with populations I

on paid that's we're even of through we I of a think, majority this today, testing to the the year. going to conduct, continue that getting increase balance

So but pathway for we actually have is me, It the investors be Obviously, we're and which how additional rubber detailed its with pleased into looking is for of how and does KidneyIntelX coal KidneyIntelX significant what some hits is and is year. next canary be FDA, or in today. on data, What care the doing would the performing looking thought at to year, filings use coverage mine you this do how do. payer that, that really where should should very we later insurance the road. payment going do, physicians it, and the which going does the render Michael affect it it utility decision

position strong chronic take into we the we as at on going believe diabetes curve and So disease, look end when the get whole very start to package around of year. the management, space we're your a the kidney bending in especially and point to in we that's market a to reflect actually in disease next

Yi Chen

would revenue feel Thank you you. which comfortable to guidance? At provide point, a

O. James Sterling

The old question.

paid ability and point. I in different for about we're get we've areas, to for is think we're this. market paid debate KidneyIntelX going get from has the difficult been get to had important. to think and internal long that reaching be confident don't ability it's I certainly a very now, the KidneyIntelX This which in starting to

effect project, exactly just So moving there. at have, Market the off not the I'm the more clicking confident to we sure end and that the say of would much day, opposed fundamentals. help. What a or how up we're doesn't position as volatility into putting numbers

next hoping that now, fundamentals, So interest we as they click just which But moderation, market markets which to about. see more bit XXXX, off come start year, little and I'm could fiscal very hopefully we encouraged guidance that the we're the for get is let's provide a early we've fiscal as position rate to XXXX inform into along. friendly capital start taken XXXX

Yi Chen

been Do clearance, to it. feel confident you get that Got FDA XXXX? you we've counting can

James McCullough

have analytical the and FDA full you up. end you of [Technical thousands we now And use And validation with do And amount the much too stop. caveat always seeing submitted certainly can't clinical and process we has validation Difficulty] data, KidneyIntelX put that don't moderated call performance have on see longer. on until timing data, patients. I But are again, of changed, certainly starting this picking the cannot across now burden you we're go the we're reaching substantial have I the of data, to COVID, game. FDA, processes a FDA so

in also FDA best the And So, I the best I've think we teams, process. outside about of the that FDA smart have very of with terms certainly team worked one that we've consultants. gotten internally,

a at this you patient day, is using population right, high, of on. on put get you is all a risk early referred, if in the KidneyIntelX of particularly So, has the existing end disease. And not the that get drug

with patients we're on focused only screening. not existing disease, kidney diabetes we're So and

is very the KidneyIntelX benefit is of the but low risk So very using high.

we're a process So the de March the But let's quarter. data I novo again, get we see in the validation believe with marketing goes. authorization all to have, how positioned well

Yi Chen

you. Thank

Operator

next our for by stand question. Please

next question with from comes Baron Our Pinnacle. Randy

is open. line Your now

Randy Baron

morning. hear me? you Can guys. Hi, Good

James McCullough

can we Yes, Randy.

Randy Baron

to on accepted And obviously, thing for Tom, this on glaringly of was question seemed last One that I week's a talking certainly determination. for milestone first today missing Tom. like mean, congrats mention coverage My is certainly national LCD announcement. Medicare call about me was being a I and significant review. Okay.

like if those to an can me, call else For for how the the is of at get not without be and rehashing script, on kind laymen scale? going like can not, paid why Thanks. explain you going you Renalytix if NCD

Thomas McLain

the you claim they first I week of And determinations. Coverage then Thanks provided Medicare. claim coverage was Randy. referenced thousands MAC three numbers. payments. number context National were what adjudication. United CMS lot and States. the review local at There last from which the methodologies. what the clear, around are around the coverage claim There's important Medicare a separate separate claim adjudication this there's but where But by of payment coverage still was coverage Determinations, of the confusion They some And are have by the distinct individual XXX local in very claim payment is conference national come for our a currently for program about single determinations, in Director the clear Medicare determinations, accounts majority

for Once it's you're at. the basically, sequential scale coverage you So sufficient a that's not have process.

relates done are our location under case, to Medicare coverage determination, local You Medicare. coverage the a the the that sample. patient with it In laboratory runs of

for coverage Medicare our Lab, we New that of to York There that's move national the local for by a City through samples on a New the York MAC next lab, if required coverage determination coverage here. So to us. determination all run continue isn't national that's a

the going is New that indicated, LCD, to doing significant, the So -- I be makes the reason process we're as is York. efficient KidneyIntelX payment in volume claims much Contractor Administrative Medicare of for more the and that

a with determination. So a is move answer… to done. isn't national a national a that Did be local coverage short coverage determination, answer on would to need There we

Randy Baron

a or that's MAC? of through let that Is the tests me push of you York could good answer. there a Well, But dumb question. ask a amount limit you New caller the

Thomas McLain

No, no, it's national.

budget. they're and that California, people all budget New they Rico people Medicare a MAC's in Medicare limit MAC as the are administer and in each the So or There the York. does claims New what territories their like is paying Puerto in region, for in located for pay for people York laboratories isn't providers is can to

“is their the contractor any are for regional payer” the national in service provided that's region. they So

Randy Baron

that's Okay, great.

Let me versus as trying XX? shift just just is to burn the OJ. September ended. happened in for aspirations cash company's what OJ, the kind I'm quarter of reconcile cash September to at minimizing were done, levels quarter Seeing what the

O. James Sterling

September going we're Not in looks is the So to September to give not like. as what we're previewing as that, on go revenue ready line. more guidance previewing far

Randy Baron

aspiration? [Multiple down way, was X X.X September question million the to to Okay, let ask me million Speakers] well, this that the burned

O. James Sterling

put slower you've number The what it was I on don't it. recent was September want down. burn historicals. in than But a seen definitely to

Randy Baron

to on how that are about investment needed reps, return Both on your James and for for talked XX test Okay. to average reps Tom get threshold? the tests many

O. James Sterling

what just trips careful. that is there. get I be we're I'm it. to got good I it worried question. not guidance, which It give a you're asking into forward-looking specifics giving to

off hold me let So on giving.

Randy Baron

sales me way, rep? what's question compensation this ask your let the Okay, per average

O. James Sterling

a specific that giving comp, based a rate either. as you they bonus But and base far provide got market to performance. as It's ready numbers… Not

Randy Baron

gets that's right, so times if gets -- how XXX an it? test that like if can X.X directionally XX look should me XXX but times at let Is I'm tests that salesperson $XXX,XXX then a that at comment average me I to million. just okay, you directionally XXX so

O. James Sterling

don't why looking that's see fair of way Sure. I a Yeah, the not picture. at

Randy Baron

of then Great. James. And for just questions Okay. you, last couple

O. James Sterling

go depending going direction there on of experience, Randy, like The level before are you on before But reps that you're good questions. I that different, in. actually these get actually etc. you paid location,

Randy Baron

you the pretty Especially remaining requested make didn’t wanted last this, let like are there James, just just there else? since by I me guys it for my to to you, a do and seems -- any chain. open I sure obvious the items miss open anything FDA couple door, are

James McCullough

At the no. moment,

Randy Baron

That's great.

think I then And Okay. -- heard I

James McCullough

end humbled, at authorization. novo of that, Just There novo de a authorization a It examples and doing very the careful to big. risk process, okay, of reasons caveat and are the very, to the there it's front and we be assessment complicated are put right. FDA a I the this disease no on de proper of tests substantial want very is are process because respectful

because would be prognostic FDA on new test when significant to a opine, like achievement, be statement of successful, that's does table. we it a obviously, and the So to a we be putting going will now class,

process what we continue or Doesn't it de looking for. we're appear, FDA the proper works, And a not believe discussions, that the put strong questions be mean that that authorization. together we will as a process additional So FDA well, but satisfied have we review is certainly package. very not way novo will additional we confident is to there the conclude

Randy Baron

and two past, in have you don't quick me, on James, ones or really any do completion calendar you then I updates the any from Okay, last partnerships partnership I'm in just just -- this talked expect of curious about year?

James McCullough

as We are I making if you year? big. that continue partnership No. progress lot of and to Can notice, No, a to interesting significant calendar make commit especially market I taking calendar can surprised I we insurance calendar milestone can't tell we a people Would But in what's with completions to I do commit I be this partnerships. there are did progress this of this year. announce this year? expect a

fully day that it, the without year we being and at think every really at analyzed is it's our year, of front landscape strengthen not ultimate beginning is something, the you one for add a it, moment. does know, starts across direct value, And they've that to open, there as next you've lot market created and the paid insurance Because And product watching when a come it going So end know, the wallets when the I as this hand. continues from about a to thought the Insurance you prognostic the ultimate, now payment, said are has people they've of of paying value. for. unfold only that's validated the that competition you somebody any validations. that

Randy Baron

you're which comment level to be, do is about, kind is and getting about last series this that's would away paid, said your of I my your that it three of milestone, and I high a last least Thanks view certainly a value, company Renalytix much. mean, less from how five valuation years me, this so at on it you paid than currently, Yeah, think just you you company, to said that? that seems getting I would thing, seed like seems mean, venture

James McCullough

Cross we where mean, Shield, close where to a mean, I long never valuation. I patients venture utility, in term as a derisked a we we have with of have a a insurance many been and I've we across at short and this insurance I've position multiple reimbursement now I again, been time still many, in Blue having carriers, fulfill. this years to literally Blue could valued where typically validated doing including millions takes could I'm said, regulatory we're which regulatory decision be

currently that understand where the we I significantly for that the biased on put is while market say the this am -- putting am surprised valued. would I'm but table, again, table. I validation the that the is, I with are of But we're volatility we So undervalued I CEO, as level company achievements on where

Randy Baron

Thank you.

Operator

Instructions]. [Operator

from question Mark BTIG. Massaro next comes Our with

now is line Your open.

Mark Massaro

thanks guys, for in here. me Hey squeezing

just kind the I Medicare continue and under announced week. So clarify you last until completed. paid process you process wanted progress on you guess also to the I LCD to will the, congratulate is But that of on verify the get ICR just to

still until whether guess, So go LCD, a is -- this here, benefit of to draft I a you series goes paid. will you'll get good final kind the propose LCD, happens dot continue will around, But rendered? a you if really non-coverage would what thing. of, you my for paid The get get have final, months you until a I just so the that's decision, on question likely if to I negative positive a is guess

James McCullough

longer the test each and there for determination, the local the claim. reviewing that So was so routinizes there under so a claims the Medical no process, ICR reduces if that what is would review positive are a coverage see reasonable If that who necessary. more of negative determination, as Medical claim coverage Director is review say need a the Directors it yeah. the that to every does

did or reduce mind. they payment when back and it guess looked say of had changed stop their they the I that, would that claims at again, went under So If either they would that data they ICR. then

if So It's I same. processing data the clinical is don't the so and our that's both in it's Mark, answered -- question. that the all conveyed know of data

Mark Massaro

you get confidence -- for that started LCD? Yeah, that that is, build And you'll builds that pathway ICR is you does well, that helpful. The that's complex that a is my think guess fact I know your paid question. my a getting that likely suspicion you draft confidence I question certainly positive the have

James McCullough

be the they're that that of MAC claim all speak But come in I local individual data efforts led considered out, the and for can't the determination to where in by coverage payment going will process. submitted reviewed the under Mark. was up to the process review

occasions. as that approach data met the Medical that we our we So Directors and resubmitted was utility on had, of all multiple analytical validation the the we took clinical with

that went this do -- isn't everything whole an we process we've you under before through consideration LCD. So done under would for There I mean, that submitting claims ICR.

information will we with additional utility data review be will So the of shared that to the be meeting the publication open the today. hasn’t in only able that you Michael

and So I well. on a at reasonable which claim would hurdle by testing say the and determination continuing a they've say basis necessary, is are as everything is for claim to local looked coverage

Mark Massaro

do have you asked in about the And lab NCD last just my great. conversations a and Can expect as Utah understand NGS wait have you other before to other you're well. move Tampa, you Okay, I know a potentially you this to out first, some pathway. here, with give contractors in were MAC's conversations process you with Medicare you us directions lab other forward? I or if in question just as

James McCullough

the Medicare MAC New the a future is an our coverage another that location. We through it run right value we're could City that another a testing be running fact with being the New see we the in now facility the laboratory York in on process of second all having is in would backup, now NGS laboratory in a region. of But Medicare right through up focus lab. or our future. could XXX% Our be the with York That open testing

Mark Massaro

progress. Okay, great. on the all Congrats

James McCullough

finally can on answer this Mark, discussion I these having including love questions, now. we reimbursement

Mark Massaro

I color. appreciate the

Operator

our stand next Please by for question.

Singer with Markets. Our question Chris Capital from next comes Glasper

Your now open. is line

Chris Glasper

guys. morning, Good there. Hi

more first we little generated if bit of color, volume testing a in the may, on Just year. that quarter you've the this

balance Thanks. more done XXXX were XXXX one offs the has Sinai, of can little which give repeat in of if Mount So whether at come just regular a or us where this systems a health the ordering bit from, many orders short you've quarter from are color that's north on stage? you tests how

James McCullough

take you Tom, want to one? that

Thomas McLain

certainly. Yeah,

the So testing looking understood future. that generating, volumes with that KidneyIntelX. repeat correctly, at question we on KidneyIntelX will And volumes, for think and are the are, it's be indications the testing, testing we're expanded I initial set I we increased the for for

Chris Glasper

Okay.

that. of in on addition now to different to a just live a sense are bit I'm just get So trying more many Mount how Sinai? effectively systems

Thomas McLain

clinical that study that and is with our So KidneyIntelX. testing clinical we at have ongoing for Wake the System, is Atrium

convert commercial the into that expect of testing that We will before year. end the fiscal

just number in of River System we coverage will in We also are with Singing and live. testing insurance in gone Health go areas also are care place. being which have And other practices, Mississippi individual where primary from within the that a focused live have tests coming commercialization

Chris Glasper

was then first And Thank sure just you. I think, helpful. I'm question that’s Dan up. answered, Yeah, VA the on from the not

eight color little VA So and the more live having with of the the a where are target you're just by on going fiscal the whether you year? rollout end of bit to a systems in hit

James McCullough

second count, we on VA so center. the had I in going that have announced a that we order had live the one update yes, with center. You're to we -- testing Today, back an task provided

a from purchase have fourth. We we have commitment a advanced blanket an order third with and a purchase

testing the to of KidneyIntelX went So those year. the eight expect on are about four fiscal Correct. and that to we end confirm up centers by I with

Chris Glasper

Yep. Great.

Thomas McLain

that Did Okay. Good? answer?

Chris Glasper

That's Yes. Thanks, helpful. guys.

Operator

[Operator Instructions].

comes Our Lindqvist Jens next with from Investec. question

now open. Your line is

Jens Lindqvist

guys. Oh, hi,

James McCullough

Jens. Hello

Jens Lindqvist

question there Fresenius stock last both week also was the Davita shortages. dialysis moment. a and inflation Medical We on from market warning flagging downgrading well, weighed this factor morning cost a Care the at know just profit but and Yeah, of I the guidance against believe U.S.

could backdrop, [ph]. with facilitate is market of patients glut have Thank technology Where that. it moment, take interested that Just I that is in on is wondering this I'm kidney you, that stage is your could the this thoughts guess late adoption intervention to just focusing be, the simply on the priority? market is for it production adverse opportunity an at of you.

Thomas McLain

and with child with into the economy And My just because poster around interest disease, is and to there was this upstage that JAMA different is we've it's to large state that a question. the majority. costs. way disease is program. with best patients from the disease these very large later expensive that with different insurance slowly of to is The the first fall our the huge good biggest is anecdotally early that taken and eventually general then control disease, breath close in let dialysis is model companies, economics but for of and the believe $XXX,XXX in insensitive a existing away kidney controlling about most problem interesting insurers Medicaid, Very to government. what I referenced, statistic payment And not disease, this populations very noticed publication [ph] alone from I $XX,XXX diabetes is Medicare. And was from and cost fact of what's And of organizations, talking Renalytix will year treat coming was the the I've and private large get this unique XX% develop business to it. kidney insurers to medical the

critical budgets government KidneyIntelX. and brainer. to what now to a getting kidney disease is a is We're for no And the need is and who to diagnosis, who's it. all paid And we This it do this getting situation, unsustainable completely about got KidneyIntelX on we doesn't. treat me is which a now treatment. to have technology with so controlling prognosis So, it's is handle and why state

regulatory demonstrating intensive data prognosis you early, physicians, show management. we if that are and roost. seeing is control more blood going to with drug emerging behavior We we're equipped And advanced change. have you is is all we're the we're care primary referral to physician, timely utility pathway. KidneyIntelX now Awareness prescription to are seeing a the now down This are new up, seeing coming

everybody's ultimately, feeling costs sensitive right to to control disease to cost. environment, early I, And so everybody is this my condition. now. That's assessment of chronic needs how risk And regardless in going the economic we're embrace on

economics terms showing of that Fresenius KidneyIntelX on I this, the continue I we're going adoption. -- insurance I a and in know you is so of questions think can't we don't And that the and publish give we warnings, health out utility have inbound into data if what's payers getting from when that's when to and comment going are to insights lot boost on bearing to really effective, happen Davita’s Tom. profit any us start

Thomas McLain

don't James. I

James McCullough

Jens, question good a thank you. But

Jens Lindqvist

guys. you thank Okay,

Operator

Instructions]. disconnect. At -- time, [Operator this for there conference you Thank this are may no concludes today's call. you participating, now

Renalytix (RTNXF) 31 Oct 222022 Q4 Earnings call transcript