RENX.L - Earnings call transcript Q2 2023

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Operator

Good morning, and welcome to the Renalytix conference call to review second quarter and first half fiscal year 2023 financial results. [Operator Instructions] 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 you, Michelle. Good morning, and welcome to the Renalytix conference call to review second quarter and first half fiscal year 2023 financial results. reminder, is a replay recorded As purposes. Instructions] this being call for [Operator for call. in you participating Thank all today's

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

will In to on session. join Technology question-and-answer hand the be addition, for Chief Fergus Fleming, Officer, us

Act call statements to the statements forward-looking within are during meaning of I'd Before that that expectations will include we like relate begin, Any make statements. forward-looking future or that management Securities of Litigation this call predictions Reform Private you performance made events, remind statements XXXX. during this to or results the of

the and partnerships for decisions, Examples the of whether and distributed strategies savings of the reimbursement product in receive and adopted potential for was submissions, limitation, the statements from prospects and on and government decisions plans, delivery of and our kidney our regarding and benefits without KidneyIntelX successfully including KidneyIntelX world and impact chronic expectations our our business and curtail change, improve of opportunities clinical financing and the the business, studies expectations care KidneyIntelX, of of trends and potential potential and policy of strategic FDA, events benefits, reimbursement optimize market development, guidance. KidneyIntelX by commercial including COVID-XX KidneyIntelX, projections outcomes, and marketed, include our patient collaborations, other hiring, revenue regulatory future growth, including physicians cost disease, operations for expectations to economic clearance ability end-stage our these regulatory

differ these those or uncertainties undue Accordingly, that should forward-looking anticipated on not events material or risks to cause could These by statements. and actual these statements reliance you place statements. implied results from materially involve

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

as events update Renalytix statements March revise information contains This future as today, except financial obligation, Disclaims any or any only intention and by or is or call of otherwise. projections the or information, forward-looking conference time-sensitive of law, live XX, accurate whether new required XXXX. because to broadcast

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

James McCullough

further insurance and Thank cooperative Good quarterly for long-term will his a including on speak next the the our to time to Administration in you, with advances, or commercial study, research the reaching the System, Sinai remarks. for results report, good U.S. expansion FDA investors, afternoon. real-world Renalytix progress $XX Health of with final capital insurance Tom Novo De morning significant a our made payment these point Veterans KidneyIntelX, several prepared towards of Peter. a transition Marketing KidneyIntelX Since Authorization Health institutional execution last and at Mount million points round fundamental has completion permanent coverage agreement new development of KidneyIntelX. evidence of model McLain

transitioning XXXX. of taking evidence milestone $X a the tested insurance Mount the expiry KidneyIntelX place Sinai, study model through System. exclusive real-world of contract million with patients part established the coverage payment to the which of for as Health completed program, expected the Mount have first testing in with is of the transition we long-term quarter, began Sinai March This permanent the In commercial at

Medicare payment other significant for possible and concentrated without disease this a Advantage ability the City was would to population for large in commercial of and kidney diabetes be This York a payers. of secure Medicare, from portion transition New York KidneyIntelX our diversity transition established Key to City. New insurance not

X.X with largest a nonprofit contract with X.X United coverage million members contract a members. disclosed large coverage recently second covering care the with value-based million in another insurer includes and This States payer secured the

both rate Medicare or now other pricing model successfully per payment reportable are being at of Illinois regional high $XXX of such major private established Carolinas. York in a experiencing result. for across and public insurance carriers This our New as KidneyIntelX above replicated and is the We the in markets region

We to review under Medicare national receive continue individual from the for payment government claim the claims services process.

from application been Mount Our determination coverage the updated NGS evidence has a Sinai. for by local and coverage real-world to review is incorporate under determination data

Medicare XXXX, other stated Medicare, For business progress to report on not-for-profit Blue our Medicaid Blue Shield expect goal primary Cross we of and insurance and with for-profit expanded state the long-term of Advantage, programs, remainder coverage payers.

and We demonstrations helping real-world a will number physician is support reimbursement, the for evidence continue road to clinical insurance drive data investment seen have our generation in guidelines. and growing inclusion that of believe use to in eventually

importantly, clinical of As Journal the real-world KidneyIntelX and specialists. urine a influencing reminder, results metrics. on referral X soon and standard improvements KidneyIntelX Care HbAXc UACR published behavior November to timely creatinine health. intervention therapeutic of favor evidence that in albumin expect ratio so to Primary in what see long-time early was that KidneyIntelX for XX, tested levels and Most patients didn't to Health showed in or XXXX, showed first Community by for we health kidney was diabetes

short of trend change in reduction such other on impact measures continues, patients suffering. if these kidney We costs in can period for the to the potential X and metrics have KidneyIntelX a time health health and enormous care expect that

from point writing up be as time real-world which months, results next We will publicly are currently summer. early evidence XX released as at the this

or value no KidneyIntelX, of primary the the in medicine. hands shortcut which showcase particularly for of preventative care Our physicians practicing money real-world evidence data in time is development to continues there

current a Also fresh capital of holders. in our institutional we infusion pleased build made well-funded quarter, to $XX into and new were million of the up base

product in regulated overhead to clinical commercial to optimize opportunities delicate highly necessary we and our need diagnostic and deployment, going the reduce remains market. capital for a forward we While balance continue maintain U.S. expenses this look for model as to fixed the

kidney be from that all report or will March Foundation Obesity population predicting hand of treatment and diabetes, incredible in that means conditions by improve history. of disease in obese obesity indicated largest one continue failure the total half costliest over negative would World the which will further the to the over XXXX of report GDP. to or world's hand Finally, nearly obesity run of overweight impact global of be a have the prevention $X The that and trillion medical and economic of X%

most will that early More and to failure, offers prevent we treated accurate who should be the disease kidney and patients risk uncontrolled disease And majority identify early kidney the the downstream for which than KidneyIntelX ever, highest to are progression, at need of prognosis effects. importantly, dialysis.

progress. turn Good Tom. will our McLain, now to our and I over FDA discuss to morning, Tom President, commercial

Thomas McLain

you, De and Good moment Authorization. like Novo would take Marketing securing drug I additional details Thank towards a provide to James. progress administration to on food morning. some our

asked, have exactly marketing you medical Novo Marketing of De there Authorization. own some devices request FDA's classify First, for provides predicate. what pathway De which novel a In the a to is is marketed Novo words, no

Since our frequent a novel Marketing which agreed designation, in subsequently device request our We there with FDA medical devices. Authorization predicate more discussion review KidneyIntelX during initial allowed has granted Novo for a test, De complex pioneering were XXXX. is with pathway for was under the discussion for process FDA no breakthrough FDA reviewers

XXXX. activities filing for internal the process reclassification Securities submitted As a we In of in to set on and FDA for March will first standards FDA pursue to stage. for completion the with end the that the the this sufficient time time prior to class decision. continues of working advanced the The of at and company order order of has and In Commission XX, indicated test. controls review this this certain effect, conjunction will provide noted the successful Exchange review, by a process, novel decision the KidneyIntelX with communicating FDA towards date outcome for in reclassification a an for is prepare FDA final the order KidneyIntelX QX

submitted and we on team point has important of KidneyIntelX information submitted learning working KidneyIntelX questions of health out request, to models biomarkers controls. to novel that the inclusion and the set This machine and for cyber includes software and Renalytix. supporting data FDA dedicated on all the in have with record application a data novelty review. to of relevant clinical their our combination of the security in extensive disease, responded FDA experts kidney timely the comprehensively is information reflecting The It has and

and review process, this With in and an of that period a potentially KidneyIntelX impact the we is millions is technology during that patients internationally. knowing complexity States appreciate in in interactive can FDA this tens that time of of a the can exercising breakthrough have long mind, United care for thoroughness

we and no are a we marketing successful with there are FDA diligently a optimistic, guarantees towards the outcome. of working remain authorization, While

We establishing payment progress. benefits regard developed large to commercial permanent in Next, of within real-world KidneyIntelX and publication began as evidence successful and experience Health in per to as Services the a long-term insurance $XXX system influential Medicare test our insurance the pricing our commercial test and Mount General established this below the expanding pricing System without discounting York. We've New Sinai accomplished all coverage. of KidneyIntelX Administration when of

commercial will James XXXX. on the a impact for reduction payment the March quarter for volumes, be for to will of in ending testing March. mentioned have at reflected Mount that Sinai This testing negative a The month short-term transition predominantly revenue earlier, full

billing, commercial also average Further, financial testing diagnostic price patients when testing. now the for will qualifying a for move and scaled for selling percentage for to out-of-network include as is minority KidneyIntelX of discounted customary products assistance

This year, veterans Turning implemented health of integration KidneyIntelX the this hurdle significant KidneyIntelX a briefly reporting kidney eventually streamline with the Health be systems, Administration to electronic will agreement The and all to to diabetic X.X to January this program test In a with large announced enable approximately basis. adoption access at-risk of VA. overcome patient across the making disease. KidneyIntelX accessible population. completion and ordering we for VA to Veterans operations phased record million on an will integrate

Turning systems. to health

the to We towards Atrium our the real-world enabled are regional widely beyond program payer make significant available coverage. system. Health test progress evidence across This health is to working with by expand their

to in Health and expect with sites. Aurora and Advocate work fifth States. clinical opportunity beyond primary Forest Wisconsin. Success to Health education QX, now entity, expand Wake Illinois this programs launch merged in and Baptist care combined here to is we'll the the system largest XXXX to also also health fiscal our We Health the their create Atrium United Atrium could Advocate the EHR program expand in integration with

diabetes X a primary force the evidence disease. In risk we Sinai is chronic have at both of the demonstrating quarter, the practice KidneyIntelX and care our current on sales ramp-up real-world on direct seen assessment, Our publication using sales on in improves that outside testing. type focused care of significant kidney myIntelX Mount portal. Based based

We future adoption opportunities is also revenue for that accessible have and these look patients. test for the billing forward affordable quarters. and their growth updates test in to practices providing assure multiple established I on

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

Oliver Sterling

we Thanks, financial X issued Tom. Today, reports.

under second XXXX, filing X-month accounting. included IFRS X- And X-month XX, GAAP report which on fiscal for U.S. reporting is our I periods is First our of interim and XXXX Both the our that are quarterly dollars, here based under GAAP quarter reports are currency. which our half U.S. December corresponds SEC financials. and financials results. will our is discuss quoted the ending our in year with second and Figures,

we $X.X of $XXX,XXX million For fiscal of for recorded year. compared the reported to second the quarter, approximately about we prior quarter revenue the total

comprised Our This through the a testing lower XXXX for GAAP we basis, to $XX vendor prior were of annual by reductions. and employee million the revenue over success about expenses of announced $XX.X $X August down period. in of pertaining reflects to million $XX.X and revenue from million quarter expenditures Operating in the part $XXX,XXX on year million in program, services. actions

the $X.XX of share loss quarter for was XXXX second fundraise million down This figure approximately per does second of was We for Net per million about quarter with the or of early the from XX. include $X.XX or as share. the quarter fiscal $XX.X This December of closed February. in we not in XXXX. approximately cash million $XX million fiscal $XX.X cash ended $XX.X

we can now the questions. Operator, please open for call

Operator

comes question Stifel. with first Our Arias Instructions] Dan [Operator from

Daniel Arias

bit the Sinai for of which James, digging from. question where from sounds overarching other I is, Utah, this Forest, institutions? should then the take on of in to the Sinai you and Mount of then the X,XXX FDA test quarter, of here, tests, versus your came kicking in from a that up the and it volumes course sequential assumptions in the volumes here projection makeup And Joe's, we down this in quarter. maybe St. over last what think year a a under ramp the Mount volumes? going the X,XXX like for non And year about starting what believe, ramp the those volume is just working reimbursement, Wake to have I mean, regardless sort we're XQ. what's for come step portion

So I volumes you calendar where you'll is the on than the by year, guess end that higher are materially the of confidence be now?

James McCullough

to A Dan. Thanks, the unpack. change. Mount coming Sinai. testing of couple is starting majority from things The That volumes of to

the full with effectively are So physician the other we're portal. and are models sales, a focusing to pay direct that's we that now care starting through is thing example, which the across completely to myIntelX on and green commercial different -- is transition happening seeing shoots, primary making board. to for something the we that's That build is channel,

thing you is a to to That volume. broad quite before to diabetes call use some referred can of coverage. Illinois in population that some an reimbursement who get close a coverage KidneyIntelX can region greater kidney of form when patients first We emerge and XX% for a the KidneyIntelX. commercial across with use where achievement. we indicated it in XX% region? believe, insurance So I have of indicated start is, drive in as That's you in have, as coverage. insurance key -- of We testing supermajority form I patients saw it enough than now

direct sales in moving we're hospital PCP different systems for integrating also there Illinois pushing to as the we're with therefore, well. and so region, And towards

of So Mount out for Illinois. growth now super with revenue Sinai available in that is majority us coverage

We should have to to commercial using be shortly The to of in that to York quite States, have regions same a And -- about system KidneyIntelX everybody Health We that is Sinai successful. expect with some a going City. news that contract full conversion in is Sinai to had the commercial the with to additional of dynamic expect occurring the the had We milestone. Mount Health including United be take other System. evidence review had in data the real-world wild independent how out the think physician transition place. Mount coming Sinai I New

of make to York on we're contracts again, because And we're number a New able now in payer execute in to a City, position the that transition.

that as yes, critical we done impact transition, in period the have Sinai. original shift. payer contracts But that is the that of We Mount contract time of revenue of part place. for different As milestone it only make it will with number March could with a to get off a

point commercial So Sinai exquisite the contract the timing get payment was where able for required. we is we're quite which to full the off diverse jump to that model, actually into can

hospital data should will from you who've companies and from the we're should it ways pre-pended also So we insurance to insurance integrated recent including done quarter health and revenue expect to own now the from taking a innovative on working you ordering, that start initiated analysis that should the be quarters now look you testing their with group see KidneyIntelX begin of to basis. going diversity independent see primary not-for-profit physician provide see June care KidneyIntelX, different large at who economics myIntelX forward, directed position, a places, it to and

get to allow because physician physicians. out a for insurance where now what that just in give substantial for hear point received cohort And that full sales majority we now to which KidneyIntelX going super they've nonstarter. patient environment base, not a we're we're while seeing, time so And a is care a the where want are scaled multiple a care us payers to diverse having primary just bill market primary seeing first again, have channels to commercial of cannot we And can without comprehensive online It's $XXX. I you a grow. you or directly an from a forecast, can cannot

seeing of emergence comprehensive you're the diverse is what insurance. So now

now You're channels, supported a direct for up new adoption seeing of are health to which is we hospital course, KidneyIntelX. adoption. care, category, different insurance-led integrated potential population And seeing opening the primary whole of system

Daniel Arias

Okay.

revenues, should Or does I that be test just the sometimes from way that sequential volumes? the we X next improvement that triggers beyond volumes point is So your because the early revenue there's test because a ramp quarters reimbursement, with X in that's dramatically think test paid improvement, volume different being there's in the is over to about which for? of the being it stages point, shouldn't to volume revenues mean, and you ramp then revenue order drive to need

James McCullough

Yes.

and You comprehensive are not volume going -- insurance be now tests revenues enabling test to the is huge we delta regions are specific out in rolling that because to. or billable between we diverse

we -- not be we're In very to this and markets resources, right? capital So be we have careful, to capital with careful. had

So we forward can past, insurance stated testing -- we the we're and billable we focused sales, -- on specific move direct where comprehensive et with have apply and then as we cetera. regions in

between be difference not test huge. will There testing a little going the volumes is to So always bit billable of difference. be and

to price don't the to are revenue average is again, I is you significant, be be think going test volume. delta, a per it where recognizable but and I test between going see will there which, think the

who equity -- want to especially small can't per just a test to will there KidneyIntelX go access We expand need you So can. minority, it's because huge health that you people we're here. run, $XXX every a There's component moving testing. we into right? although And are everybody

cash there and of will network. who will have people or means be different for federally people tested will that there be or out be are that self-insured pricing, a payer So are we who

start distributed to thing that a don't add into that But standard right? I you know model. get Tom, if reimbursed testing to that. when roll a that's you want you I customary Did to see

Thomas McLain

again, You in that should focus that we versus a and company focus have like per discipline of typical our disconnect that did this volume build what our a type reiterating to stage minimize in and contracted at and intend great rates super job realized to there, that where Renalytix. majority coverage we help then and James, is price test regions between for

Daniel Arias

Okay.

VA, To just into one the could about like getting the barrier started some sort how was year at of integration you the If of you've just bureaucratic end the personnel-related progress follow-up you the adoption the fragmented a given little like now a EHR Okay. better had the you just complex. felt faster off the how more on ask test was I'm VA. I'm on -- of extent the with feel versus some that of just I to bit there systems slog VA, nature progress in the the of are. wondering much what it that just EMR situation year, the it there. issues

James McCullough

Tom I'll of slog. let that slog. little a but of lot thoroughly, answer bit It's it's not a a

substantially this in Tom, through I being complexity get same integration to characterize. we there's And system. into are to the is patients working national underestimated time, we a available population rolling obviously think and the that going please that kidney of But diabetic At of help. a significant disease able

Thomas McLain

Sure.

pressures a would health and up can COVID environment with. to at eyes where that the are a slog become back appreciate the the that at now other is their put COVID, worse the the on consequences pandemic VHA. said, and are point bureaucratic raising how we they there That much of care during of fully be how cost looking you an challenges VA, of people budget and dealt as at both all have post-COVID think stated, didn't I we

EHR get to run the be tests VA the we'll access health to first laboratory to that, system access VA's requirements solution how of veterans’ worked in with environment. did the VHA given cloud, because those be our the develop we the basically significant. and we information Renalytix today the opportunity the were information, this to for where able using will protecting government's As patient health

it that now. to a be us ramp across instantly all away. be and forward. development enabler educating VHA initiating introducing up for And a of we that's going we're the to across success we is go that then certainly effort, the mean to that development not as starts but and going significant significant with VA centers, will which right the with we're help right and to system think It's that the There

Operator

Our next with question comes from Massaro BTIG. Mark

Unknown Analyst

This is for [Vivian] on Mark.

this $XXX continue have of going about above you instances and paid any can I talked you in getting also over ICR the $XXX do on diversity from So 'XX? outlook course think for forward. rate mentioned revenue visibility

just on ASP. So any you guidance can share

James McCullough

the KidneyIntelX going are to continue. position. to very other a but exceed contracts point being we on us future. Yes. important not We've at and Medicare terms far want we to we other been do very the us And as insurance as see review price I continues covers And very Medicare and There don't we compromise price. significant see paid and expand happy we're the that very it's claim margin individual to foreseeable it for that unique consistent in by of which price, and think validated $XXX be we That's pleased players. that are doing a and as pricing is in where

is So I forward. we'll that very confidence is price the continue think that, our high, and

Oliver Sterling

price reconsideration period could schedule. XXXX. test our a beginning reiterate price and lab on specified in is there code national earliest the year price. CMS for public is Medicare fee January for reconsidered, the a I would process, CMS that That's If that our And that set on is clinical be X, where $XXX be we would are cycle of the a price, Medicare the process, for

in code. certain locked contracts reimbursement a set are execute is for that Medicare price. until at then And price to we our that So premium

price pricing leads what contracts. So that certain above to for $XXX the is

Unknown Analyst

as the to on with? could And the number then Okay. just well. And lives follow-up you of And just in an contract covered if Perfect. update that that. private provide share you're a potentially then could of number you payers

about purview for talked evidence also or you've real-world moving needle the payers. think I

on on publication? just you update we evidence should timing So expect can us any real-world there

James McCullough

one evidence. And to This there no of So we national at get I'll list on we look a the when generation. enormous shortcuts are again, reimbursement, here answer time. terms and value would comprehensive was what real-world data for in And and took intrinsic Renalytix. the the take is top of company, it the terms in started an at of cost

from started evidence So very primary particularly that's type market. and generating it invest of that beginning heavily to level, the we works the KidneyIntelX wild, company, of the to be the our convincing validated the would real-world everybody in required in which at fact, that clinicians, was, payers, focus in care is regulators,

the for it in So That difference. critical is in that care And demonstrating pumping hands And primary KidneyIntelX demonstrate we're physicians, demonstrating now generalist just made out scale. that. of us a to at are real-world of physicians evidence results. we program became that started getting terms

breadth that institutions, looking institutions are We're KidneyIntelX. are specific evidence along we move that of health medical academic XXXX, populations. large adding expanding we like equity issues at at real-world the diverse and As also in look to

just we'll So substantial publish this to body results. of work that giving. the is a keep We've started

I expect that didn't ever don't think see that, a changes been observing fact quite The this so remarkable. we kidney these prepared demonstrated surprised by pleasantly And we've what XX-month diabetes I impacts on -- before. that health and been is X we're and my that's HbAXc UACR, remarks inside to is observational measurements critical soon. mentioned very period, of for again, the in

has so equation is health if KidneyIntelX is a deploy reimbursement. how critical direct It's well. insurance does across money care, much And economics, working. very which impacts you meaning save That for KidneyIntelX it on working primary

that, data is interconnected. get that having an now impact So ability all And is we on to evidence of demonstrating coverage. this real-world are our

evidence real-world the So is very important.

is through just We'll Mount publications circulation have results in real-world processed Health again, as program. putting System our a releasing program. be Sinai ongoing publications And that, conference evidence and this starting peer-reviewed XX-month them as summer. those We early and period an time into

release of to every evidence. months off expect results real-world We X the

So been investment that worthwhile. has very

And Tom, reimbursement to you turn the I'll on it over question.

Thomas McLain

Thanks, James.

coverage. side, is achieved reimbursement nationwide Medicare review a under individual which process, the we've claim the with On payment

Services We also under have General a contract the federal Administration. government with the

we've executed provide website. on that, payer We Beyond that XX our contracts. information private

that Illinois see near-term markets New and York concentrated State, for today those in like the and we've what that discussed significant New will in markets efforts of City are we've growth Carolinas. KidneyIntelX You revenues, York in

we've to In to those that are And other type positioned a important to we're drive XX majority payers where looking payment scale. at where now large for are for revenues with super established addition payments that that at KidneyIntelX regions. we're point we a of

Operator

next Jens question [Operator Instructions] from The Investec. comes with Lindqvist

Jens Lindqvist

A couple of questions for me.

incorporate you with First to that That's current in at you all, my that CKD, of in at are One. it I there's relating first or Or Apple genetics looking threat look its to but body exclusively some point, form? combine predictive that? would a How evidence of a including growing mean, potential not test Is KidneyIntelX? a to question.

generally? will uptake outcome in that is quite terms second are European me initiative to for expecting it and Because you would systems. more prime look the commercial of the in on The like positioned be KidneyIntelX in slightly CKD seem in you Europe, from at question Europe the what how also more opportunity integrated well health the care

James McCullough

bring We'll discussion. Ferguson this on

KidneyIntelX It platform. Just an that was designed quickly, way. is expandable

patient this precision is add add disease can to components, we of groups. record subtyping we move equation, which We can ultimately features add So medicine into specific all biomarkers. genetic can which

regulatory what with established ability additional additional now establishing reimbursement versions pathway. reimbursement design. and platform, platform the enhancements a the a is it So into or And powerful regulatory roll to an we're is of KidneyIntelX

intrinsic is folks got framework, home it creating lot to a a person of which brew to of how going get as regulatory adoption to creating of and forward and the versions the you expect of use you get Well, to standardized there's for, have different for that puts lot very so a reimbursement or purview class moving of who somebody get any we in absolutely own. can you it. tests KidneyIntelX with of are do outside So the we algorithms. The physician are challenge its to which process, expensive, associated I you're time-consuming There regulate necessary value with KidneyIntelX forward of else again, if a is it. who's KidneyIntelX think in is broad-scale paid immediate which all move them along. And use it move it,

any get generate time reimbursement much see does future at because the to so we're don't I So pathway complex validating. through and to the the and one moment. in no, see I and evidence, money the regulatory it very the don't competitive that threat validation now foreseeable the take

So entry. to to be features continue Fergus, expansive can competitive to please have we in. significant new are relationships groups improve examine or able other But to create step with different KidneyIntelX And to add those we versions. barriers that

Fergus Fleming

discovery that can there I of other Interestingly, research much how very insights in are terms it's used subclasses pharmaceutical of for for questions early undiagnosed to level to a chronic think chronic screening and conditions. They're of on population going in. and risk patients, at be which Yes. different somewhat in target. operate which prediction in largely based sub-phenotypes or spectrum the also of in of [passive genetics your both data] generate levels disease linked disease kidney on while a somewhat is companies discovery and lot And at into is to we

program effect. element implementable from overlying the the role commercially therapeutic level. that presence of the very get of circulating in just can the the in they scalable the on But and our that really and that those prime most data biomarkers we're seeing term, the targeting how from CKD understanding business and is short in of perspective. presence bring disease print findings anything and prime clinical and in of shine not clinic aspect basic to CKD you are comes how around disease. A research from translational benefit and is therapeutic what's a biomarkers context you biological and a the and central light much program process regulatory therapeutics those program that the context, not biomarkers of happening at in impactful way the So Interestingly, underlying is the that that

think[ by of to bringing novel what exploring will that some how at of cetera. seeks collect to to clinic. on assay around that So the in and that to exist fashion GDPR, something primarily novel KidneyIntelX methods, in requirements in In the insights model deploy these in we challenges how CKD] moving of best of source relation are data platform Europe. the relation which is impacts the meets data role and currently the Europe, terms et I In all of of the we to KidneyIntelX a address terms to in that therapies the really that major the

those prime because prime So by something at. broken. CKD the of another CKD we're that it is we of questions as looking serves again, in with some engage is And which that can regulators central the a vehicle tenant

in solution of to access going we're translating group, the think researchers and to from this diagnostic benefit the I really of in precision So having to and greatly challenges field scientific having access understanding leading Europe. a type stakeholder clinical the

Operator

Baron [Operator from Randy Instructions] next with Our Pinnacle. question comes

Randy Baron

were I and James, have or don't change about for seems were, you X more and months I your I FDA it ebullient in FDA today positive -- there know, Or for positive. James question tone comments are very me, you outlook? than to a on Has the mean, call been one one it, a OJ. ago?

James McCullough

I am.

of FDA, But an until to say to a enormous significant work. amount don't work. you have caveat done have we've I you be very to done amount just think it, clear. we've have I of

as of advisers, process. complex We're me-too ex-FDA. many whom what a We're deeper have something for into third-party were product. and going And deeper we superb very a not for going not have We light. is gotten

new going classification. are a for We

for has amount bringing And you're for prognostic implications advanced a assessment, has this going time, of a and lot disease data. FDA risk of prognostic -- very test that that something data. of how are front of large lot a a reviewing a a very thorough category. been the takes We to huge end in

process, I'm internally think quarter. I the if team expert the agree. Again, FDA of get in, we be given as indicating June we XXXX, information, this it COVID line. in March achieving able May just would at the lot the if designation be also Device no fun so the believe, additional obviously, this And in a to time. quarter. we're would be market date near And has up guarantees. I'd to term will confidence the pleased is FDA we'll got and specific hope keep that that cross my We're of point, fine but To but would it's Breakthrough the I advisory notwithstanding. And But very humble over us, grown in in timing. we're this there's team an quite achievement

Randy Baron

how guidance, Just for get $XX-something let other test. love cash, burn, us cash rooting some far not on for have But me you. words, to shift that take color on does get the We're million you're I all profitability? let's of get we Does give quarter. expect giving runway that average to your it, call OJ, we don't down you. on us? what for cash really high-level the any should burn. you've got to if us In

Oliver Sterling

Yes.

few comfortable got next get I'm through that cash to the we've So important milestones. the

if FDA diversity LCD Sinai. growth Mount So comes, some and revenue from away it demonstrates

in those So in yet a us as to enough can't gets interest us we February, including comment there. good on demonstrated investors, I an areas, there whether that our And think investors on key profitability, you institutional but cash set is get have to way of new Renalytix. that's

to So raise we if an need we've demonstrated ability capital it.

of burn certainly expenses cash in. revenue next for throttle good got pretty how the quarters, needed seen ability I the reduced And in depending the to are. successfully have we last we've overall couple as we you've comes where as as on So I months, and well. XX And think feel

things And I okay. so so -- think look

Randy Baron

Okay.

answer. your a Should we $X to And should quarter? directionally, sorry, I just a we $XX how actual model cash million closer Like million missed quarter, just think burn? about

Oliver Sterling

Right. guidance asking forward-looking Well, that for you're with question.

give. don't we which So

Randy Baron

the conceptually cash are Let as If low burn some certain structural reasons $XX a James. million below $X level? million, the or as get why there $X Or historically this rate way, it could was me million? question ask burn cannot fall

Oliver Sterling

of get on course, burn. of a why level can are certain which there the below Well, reasons cash

Sure, this should theoretically, call low anybody or modeling could on as as get be So but not X saying that cash I'm that. X?

James McCullough

about cash balance? burn or rate, Are Randy, talking cash you're

Randy Baron

just $XX-something got -- I'm James, get cash. you've trying a Yes. of to sense million

great of open in to bringing like never are and think in doing. you market, suggest But they're is the and You that support going obviously, to know the you go did if this be some a raise, there's a lot players, what which capital real for how again. going in you're said, wonderful markets I institutional market

a So starts this I to us? into a say, could deep could get Am thinking in about a it correct I get XX that this divide way? fair calendar to think take it's question respond, by, really push So far sense X, how conceptually scenario worst-case just it you if us OJ 'XX. that

James McCullough

are I a quite few think variables. there

impossible Are to start a the basis. in strategic answer, and the we way of showing the does decision? should investors And that FDA, adoption? Do question now we like are So coverage, in can end example, comes context landscape becomes obviously, evidence to get we we with do is, it long come the all testing to have positive get partnership? of hold with systems the comprehensive additional The feet online. pipeline after that then look for to that cost we scale this going we fire our we cash have. up, controlling a the What a assuming with

a different are of number So there levers.

we diversity sales stool, can important and your diagnostic and thing lot to where I to, and a of your X a revenue which coverage are grow upon of sales insurance we've think point legs of I exercise data a the optimism of becomes those the things easier either which you reimbursement, reaching the mitigate is is marketing this point data base; the gives And significant for and marketing a difficult, necessary depth efficacy regulation. Once it are exercise. X, most or and easy dependent and model. the got

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the I'm of to are to generate been demonstrating able Cross trying has that an back think that Medicare nonprofit, coverage maintain Shield set to price Blue diagnostic large question. company diversity of We Blue coverage, large now another Advantage, hold for-profit, the and Medicare earlier Medicare, example

XXXX, to optimistic quite question the Rubicon. we answer your the So in am actually that is, I crossed

being FDA. specific populations box So It the check will vast Diversity KidneyIntelX. And some of on would then, of term. reimbursement goes off what to form with insurance see short diabetes insurance Carolinas check of of of let's completely evidence, start like we in off the it majority coverage is be of where York, have in here to the course, -- Chicago, to disease data, the people Illinois, get New nice high which like and now real-world kidney regions published. with concentration and

now box. check we So off the regulatory

spending major into function a regions. say, strictly hire X significant those reimbursement established without our we of are we testing type against turn say, generate of can we specific "look, cash prove in those or do coverage. Then what roll force it's that of to adoption out gobs regions we X Now sales can can and to we Wall Street nationally," markets. here And

and a off, come shortcuts. out hopefully, interest no leveled can this multiyear, multicenter, very to say, are the something program to they're expensive real-world people in back reimbursement subsequently the to the capital some the We testing now to shown can works, rates with worth to have have to process a thing internationally have generate has have out today because shown is when We market nationally future. regulatory that's show open." going going don't grow reimbursement, see adoption. competition comprehensive of to any direct can everybody go who to want in then go it's and compete wide malaise. And to have get us invest because evidence to at and that its a get point wants is when process. There Hopefully, we and I markets we we that us having through financing "Yes,

and that. able the like that and Chicago, is break the to one model the cash So to York prove to population Carolinas, be we've add your got major going to doesn't answer to that have do to probably New large key markets the specific we're question And other. bank in

prove model takes to how to are a it and that business That's right to understand -- to to So we get that. evolve now. while exactly where

Randy Baron

excellent. that's James,

ask last the going really in and hop one quick Let back I'm queue. then one me to

preamble partnerships. guess quick the a comment back We started that I in that really would about about table? I haven't some heard time. a Is on with that update. You love

James McCullough

on Yes. The health major to pulled partnership horses. a there companies. was we reins discussions again, the with discussions, chill definitely And always ongoing. the back in digital partnership And continue everybody have have been discussions

to continue We major pharmaceuticals, companies. have pharmaceutical with discussions

get that get cost not synergy govern medicine over years. need It's of to It's there. of primary diabetes. interesting to much ultimately medical device to care. you point, to To control which is to at management stage, disease is There the companies. primary stop. disease with biggest an and me, happen early XX that's have many people discussion care the on very have of specialty the to needs entry with a full that and and if focused continue chronic so are medicine, next We cost there deal kidney XX to We here. Everybody are want groups that,

huge continue and not are a recognize unique is of and it chronic largest one do of to investment to data, get has unnoticed primary That diseases potential opening we more into care of challenges. that there. here, number has a point entry requires we front broad it partners. awareness becomes out white that out KidneyIntelX into the a unique so -- challenges, vast There hopefully, its and education we expanse very people more to end not at continue a that's But insurance as of And the regulatory we're challenges. significant point me, the the gone significant There's approval primary different coverage, and get strategic value. And put door And that. black a to huge as more without to as entry care. That's and across this. and

everybody And to think I year. aren't market going. what we executives think way stock I I and anything out last we until And they doing is saw a at it, et find look, talked corporate. large is cetera. senior long happened The -- I this got said, we where economy

now in if coming data and that, very unique we reimbursement able a XXXX, risk working out. I'm us. to not opportunities predicting the be starting here So of I'm available eliminating revival for us. proposition on to happen then to But we're Hopefully, pulled on back. encouraged FDA top more regulatory everybody activity. And for We're see going this is get becomes a of that I'm what's when again, there eliminate will risk.

And to it unfortunately, doesn't to running So public and this the that quarter-by-quarter of we build often going time. And sight a to very NASDAQ reimbursed. takes develop -- value. we're it's regulated company continuing that's a story continuing that peer and significant It just intrinsic real subject is good way reporting of some is lose that's And the interesting reviewed amount fact very lead to published to and value. things. a in

a level, to is clouds that So the strategic feel on certainly yes, strategic up and open seeing starting I level feel dialogue. I the We're are activity in again. lifting again, a partnering

stay tuned. So

Operator

from question with Chaitanya Our H.C. Gollakota comes Wainright. next

Chaitanya Gollakota

answered. is of on Yi of Chait been my mean, have Chen. questions most This behalf I

just one concerns you? is of FDA process. review to on the the I'll nature quick What's the So that or posing question FDA questions --

James McCullough

Fergus?

Fergus Fleming

very It's Yes. diverse.

indication. statements, a information, from As data of comprehensive we to a very of a package is to prepared mentioned biomarker lot covering in this clinical science diverse technology the fields new

also the for the and the questions have in and to to a decision to that in generate the So first of inform future and the of we and efficacy reflect about. controls order an spoke the understanding regulations at the around safety device order in FDA instance arrive the them complexity reclassification that

cooperative are the questions reflective undertaken of interactive. the with So and and we it's very been FDA, what novelty of the and complexity are

So question. your hopefully, that answers

Operator

concludes this At This conference you Thank time, no further today's participating. for show call. I questions.

disconnect. now may You

Renalytix (RTNXF) 30 Mar 232023 Q2 Earnings call transcript