OCX - Earnings call transcript Q4 2023

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Operator

Thank you for standing by. My name is JL, and I will be your conference operator today. At this time, I would like to welcome everyone to the OncoCyte Fourth Quarter and Year-end 2023 Earnings Conference Call. [Operator Instructions] Thank you. I would now like to turn the conference over to Jeff Ramson, PCG Advisory Inc.

begin. may You

Jeff Ramson

and today's operator, and everyone, joining operating for year Thank call thank to for highlights. recent and conference financial quarter discuss us XXXX you, results you, OncoCyte's full fourth

today's seen website company's Investors not have the you financial press visit on releases, results page. the please If

events future President forward-looking company remind encourage Any Before during you forward-looking XX-Q, described forward-looking law. otherwise events. from disclaims from Forms OncoCyte's by which required Josh this turning statements will Officer, or forward-looking identify XX-K Actual not risk Executive statements. what conference that are and including, as implied these specific the company's to over limitation, may be Chief the OncoCyte the without statements forward-looking make you or company's that differ statements. in and projections is I'd regarding call to those call, applicable are the fact factors that differ these may under Riggs, except may and and like results outcomes review statements obligation these expressly filings results to materially to SEC or to materially update historical intent expressed We actual any cause statements.

the turn Josh. call I'll that, With to over

Joshua Riggs

XXXX, an a product $XX our ago. GraftAssure. converted ago, Thanks, for find and easy-to-use a going year from burn We and quarters average burn, Jeff, welcome, X we period IP everyone. Including for into distribution been called partner of we were package QX LDT compared the that past year said manufactured workflow our A to commercialization. our reduce transplant our million for million has the same $X.XX to successfully

manufacturing in assay exceeded to our last came prototypes the quality I'm expectations. December proud of that and has first of performance The out say that year. of

to and release. QC shipping expect first full QX production in begin the lot sites receive first We our after

the accelerated of global development base offering commercial with partner support commercial invested current Bio-Rad market at to build of partnership value. a strong GraftAssure and to the alongside and from. an support in yesterday, investment new OncoCyte The placement launch priced lastly, the efforts. with we announced private our and Having shareholders product. highest And validation investor the They million to as them level and provides was $XX.X

part of As Germany Bio-Rad and will commercial as in with commercial exclusive U.S. and distribution OncoCyte the lead. granted OncoCyte acting agreement, countries, these the co-market rights. and Outside has the been global Bio-Rad assay

reach. the to call team rate. performed are at Having minimal lab the transplant the of meet most us really to population that incremental XXX,XXX transplants we and meet this puts commercialize is product performed. a that market points, central X.X% At headcount. the try The in a where can Globally, this robust kitted growth unserved. highly It's we around gives market XXX going of States. transplant with support the need centers is top over Bio-Rad Much academic the challenging effectively market with within A demand partnership Germany scale United are countries annually with global underserved the with in opportunity. and concentrated or in surgeries U.S. both

and core designed committed and companies widespread a technology product to the adoption efforts to in clinical regulated joint of the beyond. have and in both forward, developing system distribution States Going facilitate United

discussed a as market look OncoCyte. to community. This transition subject this IBD to on and key labs an objectives. are as product step product we FDA empowered development equity an the with transplant that is path Working are this on to in rights local commercial We've where meeting possible. Bio-Rad central a come would on one progress. deliver upcoming to clearance, working monitoring team to the dominate into the accelerated Exercising market to in We direction. at been we labs has their where forward needed serve investment believe bring with look option from for IBD Additionally, forward experienced together, granted second specific option to one our quickly to updating that partnership to

the Prior we rapid monitoring an that, researchers the and labs are the DNA to offer and to going blood. test use in through GraftAssure cell-free an kit, for donor-derived our opportunity to measuring around easy-to-use world technology turnaround

to installed measure the technology significant rest encouraged their build excited in of patient interested body populations We success knowledge research doing and are to our are our the couldn't early and more activation, on of these We XX Bio-Rad and capable the We're push a literature in-house sites base tools be world. to going XX forward. the adopters into world next months the around response and of forward to site hands over the that institutions supporting the X by to put day researchers and by for to U.S. alongside of demand look in markets. looking

We continue claims build data we Kidney. of an expansion year, for have be opportunity the when was presented published. that cause on at for development It the review. Claims expansion to would clinical This today. that products. achieved opportunity have year, in an testing Last progress reimbursement VitaGraft is to the currently we ESOT beyond we make claims gets our for

showed is a in ahead rejection data months study kidney of technology patients DSA-positive this dangerous our care. of from up and a common reminder, that organ standard of randomized XX pick interventional can type a ABMR, As

DSA positive The at transplant. X those using other earlier them data The XX% didn't. into kidney biomarker kidney put the for that organ. their Those arms: than of sooner DSA-positive test DSA our one tests intervention. used much that study go patients for able test have that risk and technology rejection were opportunity the of DSA our that are for used used to This for rejection. an Approximately is and within X catch organ rejection potentially transplant our in is a showing for of lose higher health first become on Those to patients years Many will will didn't. gives monitoring patients. positive

to very ABMR. is treat. ABMR hard drugs trials new are in notoriously important, treat certain Further, and DSA-positive to But

Assuming become positive truly trials, early will of crucial. these outcome diagnosis an

We they the these studies in difference. has technology closely potential patients be II watching the that opportunity make change diagnostic to that to front-end Phase believe have find And outcomes a the for to to ABMR. our are we very as time patients these experience many the the

received waiting presented several For multiple months. that AACR Reimbursement are past pancreatic under in the into the the is of to under episode This has have these in publication LCD of of for assays X,XXXs LCD-XXXXX. XXXX DetermaCNI, at care. we MolDX earlier submit same to on types the data reached coverage companies per

make would to to from study ran those treatment post represent to samples patient by For opportunity from progress processing by Success being decision DetermaIO, likely in the benefit Southwest an for Oncology the this NIH. immunotherapy. TNBC most the we XXX-plus support by study identifying Group continue surgery funded patients the these

leaving On cash on This $X.X X the cost year. did million reductions is our from million balance burn the benefited declined first QX financials. improvement a quarter, sheet. in we quarters in reserves the in XX% $X.X Cash the year-over-year. of the

from and cost were quarter approximately Our services revenues quarter customers. XXXX $XXX,XXX for consolidated of for revenues of and the the $XXX,XXX, fourth were the fourth primarily approximately

we $X.X XX% our from million, the fourth Research year-over-year from development product and program efforts our on and our on and Sales from decreased to product. fourth related marketing by XX% where marketing investment increased early million commercial successful from driven early to assay. our reduce to $X.X not sales million, investments pivot our to manufacturable $XXX,XXX to quarter increased our $X.X for fourth and quarter development year-over-year developing expense XX% $XXX,XXX million the version RUO the $X.X directly work General expense the market for and spending strategic the reflecting administrative of expense focus year-over-year access access and quarter for to focused activities.

to of million from operating compared XXXX. share adjusted as $X.XX share of same increase fourth loss net the of as period an million Non-GAAP million, per for $X.XX in to $X.X or the the loss loss was per net GAAP of operations $X.X a quarter fourth quarter XXXX. continuing compared $XX or for $XX million

our have operating included GAAP financial release, also and is with which available reconciliation between non-GAAP tables losses our at provided oncocyte.com. at in the earnings a We website our

Razor operations for discontinued as presented all financial statements. operations have of our the reflected periods in We

has only In established a it has my good the demand. closing together. Bio-Rad clinical it remarks, comes chance It work we an and about ultimately is a you any we one But see little in makes to an invest it bit opportunity once in I'd that's from talk that one like makes the the came why What market, to that's product, take lead local. to and expect. is and to think timing. centralized exactly along what special would where what robust channel commercial shifts given what partnership the It led what

never sense transplant another for reimbursement add in only happened to happen to test, among for eGFR, have instead you up a to back goes business happens to state. a And a in only week again, a from being rate in testing, an you thousands waiting and It to an easy-to-use if testing, build of start the that in a After labs in would rather it's transplant. case. PCR centers HIV makes that It have it about something pretty access answer compelling testing, to others, respiratory lab day results once. And centralized. that local it's

X being have transition partnership hopefully that right right to OncoCyte as patients we next years, believe and mean tested research, product more will the the place more That we in this leader see a and going outcomes. position and better to transition. Over that are take the

Our have appreciation current supporting you. our us new goes who in joined and the Bio-Rad and this shareholders vision. team Thank out to

Operator

the first Mike from your And Instructions] question comes Matson Needham. [Operator of of line

Michael Matson

Bio-Rad just agreement. guess a the few I on

if tell So installed base o-US, could what us is can their U.S. possible, run and the for machines test? that this you

Joshua Riggs

disclose publicly They don't base. installed their

Michael Matson

work. clear I fine. going that's make to And how No, just and then Okay. understand is this sure be to

them. So initially, you'll of There'll use-only research test. a version be be working the with

to up for have sell kitted try have their initial and to customers You'll then them some testing eventually EU-cleared you'll test, that build test and systems. of versions using the FDA-cleared

Joshua Riggs

Yes, correct, that's Mike.

that's that the overlap be calling side centers point, surgeries. centers perform we're the talented Bio-Rad science surgeons And it. which is have on call academic a between and academic the today where the our life nice excited being actually happens research of so who can done the really by to There's transplant

that So sense. a there this a made call point make really overlap was and lot nice of

Michael Matson

or minimum the it. then any anything Got agreement? like And that volume commitments of there is All Okay. kind put in right.

Joshua Riggs

not. are There

Michael Matson

way CLIA are And test right. testing it own to result or continue of is offer going to in the lab your All U.S. transitioned you Or transplant a in kitted? being kind over then of facility? Okay. as fully test the to

Joshua Riggs

site -- to kitted wonderful the really absolutely DSA-positive our single We to forward our Nashville. bridge we lab that's able over like engage us in work. then us FDA, It's with that lab device being we're take will to so the through that through to expansion service It efficient gives vehicle our look a claims product. do MolDX two lab path future. and that single It's establish through claims to those things the development process and doing a use a a can we we're site together our clinical can to able maintain we also the bridge with or the in path clinical patients. predicate And work, through believe do the to for FDA

Michael Matson

Okay. I for version pricing you that, And once of cleared test kitted willing transition then but... the on product? to expect don't finally, what fully should over know you're we if to the a the disclose

Joshua Riggs

mean, I usually can how Well, the you works. I math tell

that's can on reimbursed usually about reimbursed customer for value for to you're payers, pricing. bill XX% so the is test, depending the So and value your the of the capped top the end at whatever your whatever of

of for expectation math $XXX. about it's the $X,XXX, in the industry. a kind really so of set then the generate it's limit just it's really national result national $X,XXX. kit, exactly to the that's price has the works it's and we kit a you tough that And you would price And way $XXX. price. until And to have that's we can If the the the general $X,XXX, charge the If where say it's $X,XXX, is have if

Michael Matson

be you'd Bio-Rad? then pricing you of I But portion Okay. would assume that -- sharing a with

Joshua Riggs

That's correct.

Operator

from comes the question next of Mason Stephens. of line Your Carrico

Mason Carrico

Can you me guys right? hear all

Joshua Riggs

Mason. Yes,

Mason Carrico

incremental strategy detail provide if bit Bio-Rad more with kind today on given just have? you have to the what work here. don't going What place mean, of or made do you're a quick So lead, you of do need how mind, here? few team type ones commercial Could to maybe in is I of just forward? the presence commercial a you you type investments be going

Joshua Riggs

we're and then in about already so the headcount, incremental U.S. Yes, that add the today machine X small Germany. place against to the X U.S. Bio-Rad Thanks. And Germany. marketing team top in goes of on X and expecting in that's our in

there. how commercial we the filling so we and of the as Bio-Rad will you distribution full the at end think the Outside of cost no will on will relationship X -- if so then the work. those the accounts And funnel, them and bear funnel bottom that, kind has is generally lead we're of of incremental closing and territories.

Mason Carrico

it. Got

well about cash talk Okay. a as as And could the forward revenue expectations outlook? going burn you bit

Joshua Riggs

Sure.

product an so it it running. it is and get bring takes a it time validate for it RUO up, to and So lab

day And expect revenue then so converting that in revenue the and there. will X to the from QX, we into customers will build start sites start

And and forth so so of through in QX more little revenue see QX, bit year. so in we'll and QX on next a

just burn. million see committed expense. The to in us on onetime I maintain basis expect here maintaining a with up to you average. a and a think We'll burn, try low bit can to take burn $X manufacturing that cash But expense cash quarterly below QX we've some

Operator

Company. of comes of question from The line next Bruce Your the Benchmark Jackson

Bruce Jackson

with start scenario the easier with with into not this that getting Germany. works we'll of how and international markets the So are Bio-Rad, mechanics the

of license how So sell how if going it Or hits that test, to get nonoperating a then me you? going piece fee? are on a Is in the come work. it one that just booked the income does mechanics -- they as expenses? expenses Tell to either or to the statement operating the of the like

Joshua Riggs

No, good question. supply and a It's manufacturing agreement.

Bio-Rad end the is line manufacturing So then and of it comes customer. the off our

hits And a see and the you'll line so top calculation. COGS-type then it normal

Bruce Jackson

United the got Okay. with of you've lab so the And well. then particular, as test version States in the

So are then streams revenue the going be the be like going two kit So also of to here? lab there's there's to sort and revenue RUO they revenue.

-- tell to that the how piece going does it So me of flow? is

Joshua Riggs

up show Yes. as question, if as just that products. on services they'll up show I I mean, top the and one will will know your both Bruce. line. One up show don't answers

Bruce Jackson

on it It spend. the does. And and then question incremental sales marketing is does, last

per is million quarter the mix $X -- going the just expense little helpful. it Or sales in to maybe So I'm marketing? quarter is there than to be shift from any operating -- less just rate per $X color million a be on burn R&D burn would rate and sorry,

Joshua Riggs

Yes, sure.

sales we support the think and are to adding I quarter. to X team on our marketing about this planning headcount over next

Again, try deal up back quarterly we are burn. obviously we And maintain so manufacturing will here we'll million go can that costs, that to to then tick just onetime below that up bit. in that expense, well with tick will burn. And some as but QX right to as we low little $X a going

Bruce Jackson

agreement. for on All Congratulations right. it That's me. the

Joshua Riggs

Thank you. appreciate I it.

Operator

There That further are session. today's conference our time. at no This concludes questions this Q&A call. concludes

may You disconnect. now

OncoCyte (OCX) 12 Apr 242023 Q4 Earnings call transcript