Sera Prognostics (SERA) 10 May 232023 Q1 Earnings call transcript

Good afternoon, and welcome to the Sera Prognostics Conference Call to review the First Quarter Fiscal Year 2023 results. At this time, all participants are in 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. ahead. go Please

financial Good quarter Darcy. the Welcome Sera released to of March quarter Thank XXXX. XX, year afternoon, XXXX first its Prognostics Sera fiscal market At for earnings Prognostics the the ended you, today, everyone. results conference close call.

from today Greg will Presenting Critchfield, CEO; and President the Moyes, Jay company and our be Chairman, CFO.

host the today. After During released a session. the we question-and-answer call, financial we results will we will review which,

earnings chance call archived If can and release, via you quarterly had our review website it This will a in found seraprognostics.com. to live section of have can website. our on be seraprognostics.com, Investors a recording be our not the heard webcast at at be

projections results have results adversely forward-looking and circumstances current our of Please opportunities. the events and management's and yet a or for and actual not reasons. statements differ on business, about note based and some variety may other future the may These that, are statements market projections that of these expectations including information trends, occurred, events plans presented materially for financial contain or expectations, from and today

results important company's XX-K, forward-looking factors Securities XX-Q to We time-to-time our projections report the company differ specifically risk cause current other documents reports from and to its actual and and its materially These statements. Form annual the identify Exchange that X-K. files the with on documents quarterly reports Commission, Form those from contained the refer you on the Form in on could

Investors of on section website. this our reminder, call replay will the As a available a of webcast be

President to over and call the CEO. Sera Greg, turn now Prognostics will Chairman, Greg? I

PRETERM fostering and pathway TRIAL The afternoon, good developments start results PreTRM Sera both February conducted has fiscal expect we test AVERT will early broadly commercializing in and Willing toward our top from revenue and growth. while of us been of for the line Key positive solid of ChristianaCare, Prognostics a of in Delaware. year Peter, you, encouraging with XXXX our be for more what everyone. Thank strong announcement at exciting

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of in comparison a reported. and first XXXX XXXX year-over-year showed quarter XXX% A of tests the increase

are these yet While growing we a see admittedly continuing demand base, on to small are grow.

orders selected we are adopter the the most beginning customer to or progress speak seeing. we who contribute of are making to many are and are about early While physician unable to groups, we with hospital of practices numbers increased systems

integrated reduction PRETERM trial. or co-primary preterm both bit clinical their with some outcomes, this to who adopter outcomes the networks and clinical for neonatal a of neonatal being for If the remind trial, and severe outcomes submission prepared scientific key in may terms. morbidity I decreased our significant. approach requested early are death see statistically preterm other stay to length endpoints you AVERT more on with improvements test-and-treat data met of neonatal of hospital A also are They're TRIAL that and being the

results of and builds including generalizability solid from results widely meaningful and on PRETERM The the the demonstrate AVERT studies, results strategy test TREETOP achieving TRIAL in PTV. in AVERT these Notably, clinical PRETERM paper, prior US accordant populations. treat diverse more prevent

The I our resulted the announcement to There discussions parties increased PRETERM February interest underway. highlight systems health in with of are AVERT points regard in to with these two seeing like results key from would findings. TRIAL

utility showing test unstudied adopters driven been our new our population. by of have the AVERT of of first Some has PRETERM in treat data the diverse previously PRETERM a testing early the they learned strategy compelling PRETERM of public availability as and volume clinical of TRIAL

and endpoints of on the call, submission the secondary last additional subgroup prepared to months. our a being mentioned results in scientific detailed the pre-review coming trial, are journal as analyses And and AVERT for including

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And study. bit on now the a PRIME

recap about me few results briefly Let our a and how relates AVERT positive points of to important it Prime the study.

the completed to continued, enrollment recently study X,XXX be the trial required enrolled -- during subject the starters, PRIME analysis for interim to subjects more occur. than in For quarter, trial surpassing for the increased

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the We -- a between provided quite differences our our studies on PRIME AVERT and the in transparency similarities on last and bit call. of

simply stay Avert reduction studies I'll decreased today. and summarize for neonatal So length of and identical have them morbidity hospital endpoints Prime The in and mortality. co-primary neonatal

including clinical both but Both for management different. and similar. that differences intervention potential strategies prescribed noted similarities may the caution have positive diverse could protocols results, multimodal demographics for there in that study -- possible These are to be some finally, PRIME compelling profiles. are we risk pre-existing are cause be care and results the And for there

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the that treated early. enrolled and ended is were COVID study patients in prevalent Another the before that reach term difference study AVERT was area all in

AVERT able same off treated and some others. interventions after While for subjects during and interventions subjects been pandemic PRIME elect some the ask patients of will others receiving substantially weighing. to prime the have were whereas pandemic are the

arms. PRIME is active began. during and RCT and TRIAL as and set enrolled anticipate clinical design composite approximately provide had report concurrently We X,XXX expected randomized rigorous will before a historical PRETERM completed from analysis of believe currently a out actively evidence the the strong patients who AVERT enrolling utility trial that study control multi-center the to data by years The controls two XX,XXX pregnancies

last randomized to many compared call of a is representative control as AVERT, the much with almost four X,XXX quarter's prospectively each by on enrolled better including times PRIME patients study from and in broadly and X,XXX look twice subjects, many a at patients controlled as approximately numbers power, active study, at the enrollment. total, X,XXX To point interim clarify in contemporary full

Most higher important, we with strong XX% power of believe approximately of interim with statistical at analysis final completed power it at greater is look PRIME's statistical readout the pregnancies. numbers even

the and driving revenue is of encouraging are a time. results as key hopeful over well of compelling for and the outcome results since volumes although we as the guarantees a similar positive PRIME no will availability data be of test enabler are Ultimately,

anticipate place PRIME, new In later we of year. data addition clinical to publication compelling further to this take

more And now information pipeline. Sera's pregnancy on

robust using We meters our pregnancy continue biobank to data meaningful predictions. science progress make advanced our and to good create pipeline on

are first To A c to predictions. that pre-term step data validate developing the our in products to for for discover point, prior scientific Indiscernible] is review submission ready and publication.

We also berth to individual inform made personalized timing delivery the validating excellent to for on time prediction of on a patients planning progress better purposes.

gestational We have mid-pregnancy predictor. discovered a strong diabetes

best communicate as and We timing we'll ways predictions monetize to these and the appropriate. timing will determine the

information efforts these to the and of be in believe health We pregnancy company, help delivery. to valuable the babies providing pregnancy all and of its care economics mothers improve quest the well-being Sera

our I'll quarter first now review call Jay financial over the results. turn to a of for

everyone. Thanks Greg afternoon and good

level and first high general Let XXXX. financial to quarter at the first view our $XX,XXX our the was Revenue review a results quarter quarter of $XXX,XXX me for the XXXX. for XXXX first for compared for of

revenue indicator of growth. a promising we increase test volumes, in noted, both and experienced an of is adoption which Greg As potential test our for pre-term our improved

for million expenses the period compared were quarter $XX.X million study first ago. to XXXX the million down million costs. from almost year and development Research primarily were the $XX.X $X.X million same $X.X of prime increased due operating quarter Total to $X of first expenses for for a

first to the Selling, to our from carefully prior a bring This the year general, and end $X.X to $X primarily same broadly year decline pre-term reduce were test resulted last a million. costs XXXX ability marked successful ago was administrative and to quarter market. the impairing more our without for of steps expenses our of million from period for

for for from million, was net the of XXXX. for first $XX.X quarter quarter million quarter down the The first -- loss $XX.X the of XXXX

March had of million. of available equivalents, for $XXX sale cash XXXX, XX, approximately securities and cash, the As company

operate We to without continue capital. enable to prudently to manage additional raise to into our cost us XXXX and cash structure balances having

announced and AVERT in following excited February are PreTRM volumes data the We by of the we've in by seen testing our for increased in positive new the TRIAL. PRETERM availability increases interest test

than $X our to XXXX While on this changing our later as call this when revenues year noted help business fourth we earnings quarter drive we other and that, are less shared outlook not be readouts will belief are our expected million. adoption,

the turn to back I'll Greg. call

the We updating and progress year-end be Jay, tailwind. continuing AVERT call you on attending an Thanks, along to for to our everyone, today. with study encouraging forward positive our results, thanks, through look XXXX,

see results for business, potential pipeline. updates publication well including of other study additional as We our catalysts on our as

market valuable and providing reputation build position We to on information. for Sera's continue pregnancy

our and babies we This important Prognostics, to care health pregnancy excited care leader, wake vision costs important this as for health make society our as for day achieve a Sera space. mission the We is for mothers work company every up and and to in whole.

the questions, will And operator. up I now, open line for

you. Thank

from Tom first Stevens session. question-and-answer our The begin ahead. from now Cowen. will We go comes [Operator Please Instructions] question

also versus maybe I list be question how there. you that? question. to had competitive Thank seen kind and wonder to and to on, response data at of came time try if of kind any also a had PreTRM I the a you. approach self-eDNA out publication proteomics approach taking will of for Thanks guys. kind differentiated if looking yesterday set Hi you've that assessing your

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predictor itself. it's a very So well-performing

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showing stratification That's we furthermore, data well-being. of thesis. amount be that large very can really a can improve our and stratify employed have to We

maybe on picture. the And a I longer-term kind then, had of Great. more just follow-up

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Yes. of for What can using in tell impact data broadly US you It's we multicenter. population. I it qualitative said what is picture a as a believe a technology set ways, of -- it it. many I The is diverse is, can a -- study, will I is give the our in you definitive before, be PRIME

will the being we supporting been expect study We a discussions of also what believe to are to harder this as in have might see this that one with AVERTA PRIME. be see for They those as the important payers, step them appealing company, being an forward. all in very study reasonable those view that

takes far the said, enablers certainly believe of the revenues payers to as are eventually differences believe as of to benefits to lead But professional getting there build about that of can building knowledgeable the we time they're two, getting revenues. the one them one both it guidelines. key between I As revenues We is organizations That's go, but that reimburse. there.

And that getting and test out of and can actually hands in demonstrate benefits. the putting it use the utilization doctors

reporting get current we're us So things prime soon We there. being enablers. is out see as see fairly time. and pathway has about a all the how our take those We enabler data we to stronger clear that

queue. Great. the Thanks. back hop in I'll

Tom you, Thank

[Operator Please question comes you. next Cowen. Dan Thank from go ahead. Your from Instructions] Brennan

price the for one. Guys are you? you're two How of getting

Dan. Good,

question a the Maybe on burn.

burn So think for do this year? about what the we

do Yes. Jay, to that? talk you want about

I shape changed. Sure. our explanation on I quarter to our XXXX, cash mean, – through that that based great we in last transportation into think were well in felt to hasn't that we

can you the from our quarter, fourth pretty is to first I mean extrapolate I rate So modest. burn the quarter think that

important that, coverage, successful really Is that to is be certainty that notable -- kind is Okay. guideline there will enough of PRIME there or kind is and assuming of study know want a trigger payer arm. the there is studies. the chance one, that AVERT large surrogate I an prospective study and guidelines but it that certainly, have payers would the two did

prime enough? like there is wondering, it going So be that I'm ahead to is of just clarity

that are we've prospective actually studies okay, that three we're There Yes. done, completing.

controlled second study. first is the then The third. was PTB trial. The one, study Prevent was randomized PRIME and AVERT prospective That a the is the

of So we of numbers as work counting believe simply go, data. done far as that ample is to provide stains numbers prospective studies, someone if we've

evidence in Another the now And be certainly piece that forward. thing for technology. type that as and we looking are that real-world to time, future that we systems the of And is by are announced we're evidence. of right will some going be discussions can at -- using move of the as those people those doing in be those the another are health

studies payers can might with interest with well of payer So I to to we likelihood it know tell their of possible possible. not cover. positive the want you an able that would say, actually is That's being meet to support someone they end make reach But with decision so track. that very results, showing of point the they the high. and their a certain that what they we needs is they fairly efforts. these done design were And for like the we're conjunction of in they on clinical ultimately, that believe don't. payers But what cover

assume the the you -- well, success, we'll to the interim but it's interim. alone are XXXX data of payers guidelines, be and not out us wood, that what What Great. And knock let likely full data assuming questions timing in could -- is know and that data so because still out successful before powered on the on do Thanks, on actually full of be it's still of data. – impact impact I you of see just like, want full Greg. look say, just remind have to full the when kind two impact going will the us know

Okay. It's a Dan. fantastic question,

longer in have interim positive does it is committee access a explain very they no clear control -- that in because safety start positive, to the don't ethical and to terms. superior. If it's me have monitoring a enrolled Let protocol the the where trial look it's is patients

to that all patients in time been X,XXX the the have patients interim have completed that So have than analyzed. if is add pre-specified. that all happens, that we to deliveries are look -- the that those enrolled up are that And that

You have those remaining ones. They've already delivered.

a completed a the matter good just a cloud So it there's it's matter be to to discussion if months -- let's good assume stopped. So and is readout -- doing it's will I a data would of chance There's the that think event have XXXX. able okay? of data take get in that positive that for that interim during that happens, completed look is trial a chance data a we the sake and

following you're don't -- much groups already we have comparing the So to don't to is ended, our you for two delivered have that patients outcomes. have up the wait longer because trial

the You've that look interim that of help? -- interim time occurs. got the the Does outcomes the done deposit at

helps. in guess it. that Yes, back queue. that's okay, I Thanks get Yes. I'll And

Tom. Thanks, Okay.

you. Thank

Your question Citi. comes Patrick Donnelly next Please ahead. from from go

there. Hi,

payers? on just see Jason got across guess on happen? health AVERT medical the take needs you physicians, Maybe place a Patrick. do and institutions for and what broadly for submission first I that peer-reviewed to that to implications what journal And having to You

question. great Yeah,

to in for let's it mid-February, So the a the We and to is submitted. the when data months and became be be completed okay? up that that data PI anticipate publication the for couple takes writing known remember, were -- the of now. available data And

we reviewers available and be say possibilities data are to forward making complete are But certain that seeing have we of the the and readout, the would formats by there what look allowed once under that key journals authors.

looking can ways do that we're into we that. So

systems with announcements, will But certain able having articles earlier of use We when even we're those. health whom with are published, make announce CDA, and -- will to we things we'll these share discussions. under course, we're

that's doing. So to we're forward looking something

yeah, studies. done, large responsible that impact been will have doctors fact, study, is seen be? things, evidence okay? test-and-treat me We've aware a positive got studies prospective have that both does in with strategy become you've It the work. two foreseeing What other partially that, is this and And a increased that is revenues the already This shows makes there along difference. say,

phasing about Got sequential thinking just And we a it. on second That's the year, just throughout for helpful. of modeling we Could one traction be see during And for maybe reiterating should How the continues half, think whether about the payers or year that? be that purposes? how the ramp volumes that further grow? from to guide call. we should XQ the it

I'll make comment. one

is Our focus good early adopters on a systems as one.

You gigantic force do a out don't in need order to sales build that. to

be so modeling at generating And early doesn't days, see So in thinking of build-out. that's you ways feel might growing a you to as with need the things begin where revenue. much manner good a efficiently that have a cost-efficient about do way one that associated we're very in we revenues. a the But revenues of cost always looking doing, going, position we're we that we're to in

much place, takes a year are, price place be now, a PreTRM are will pregnancies the very ramping and in way. we number for the cost-effective decide that alone. Those it discussions million position doing our larger be do fact, a company at to in get three will of we of Once patients market looking use the expansion, how test taking up to out how in antenna then [ph]

in want too for come. much to revenues advance don't and hire wait the to You

build and demand, You that's there's out. places and build revenues the the in really to to to way want where it promise go

you Got it. much. very Thank

bet. You

Blair. comes from [Operator Brackmann Andrew you. go William ahead. from question Thank Please Your Instructions] next

Thanks question. for the afternoon. guys, Hi taking good

same of it are the you across what versus I what used population? in for you're noted on interventions the to Thanks. using how when of study test, had PRIME, that talking AVERT, And they didn't. sort which think But maybe, current PRIME? here does you I to entire intervention compare the guess, users patient their that

symptoms -- progesterone. PRIME of are quorum a that in be the by shown The if in fast-print then or with early. of encouraged that physician in offered more the study, be that interventions were patient are intensive the they we're care The and prompted and were because patient in delivery Those early there. administration Okay. and steroids was has to follows. they occurs are signs developed were AVERT management the in that of patient delivery, very PTP was early effective of a as very to delivery, the offered been kinds were PREVENT monitoring the things they low-dose that There that of imminent

that are patients at higher typically things that does These one with are risk.

the They PRIME so those X I clinical protocols, difference elements present And our And AVERT. being prime in presence are as which stated, the protocols, in had everyone in includes the not the the study. design study other. AVERT the interventions everyone features of form of one treatment could reverse. the in PRIME some access, do or and to of that's one elect And the had and patients

Andrew, actually result. Even positive saw even it, Okay? do so, we didn't they when so a

that's encouraging, very So actually.

one I pipeline if could, the Maybe certainly. Yeah, here. on just

sort take talk to be validation that on there to able other test. at launch? caught you provide out Thanks. that you a think preeclampsia else I and might making about there? through needs into commercial the final of get what done you to Any high level Can progress color just

Great Yeah. question.

our a Preterm preeclampsia is dilemma. the preterm is serious a where is So there condition clinical most pre-class preeclampsia. test

pregnancy, if deliver when delivery because -- baby early is do treatment you in If you the it's definitive preeclampsia. for actually

situation. challenging a it's So

in a both preterm baby others, validation. mother We've have more the and outcomes proper The done preeclampsia. severe

are for data ready the said, I submission. As

you of be might publish available data. at to first One of want to And how ways those then steps the do looking the would we are is this made market.

all it We the come -- market. may test are on definitive when, are haven't come available that the decisions this work made our learning the to other pre-classio. pipeline ones tests and yet, pipeline any making There actually be decided actually but now. in that of do our to we how not ultimately exactly planning that's we're kind right We've which doing of across suited about but

Okay. Thanks guys.

Yes.

Thank [Operator Instructions]. you.

Please Stevens is Your follow-up from Tom question ahead. next Cowen. from go a

for question Thanks taking guys. Hi, this for last me.

what's associated prior kind your and there's or guess, partners be would cost any your on accelerate with there? just What the there investment potential commentary to potential I there out force on that. of really there? always overcall. on would out out kind is growth? of call sales ramping guess what earlier acquirers So that of And kind a benefit acquirers pitch I

are that companies could there -- some an acquiring be the like interested Well, asset Sera. in

make create looking As think we'd we have we point the at interest. before consider stick price, course, build grow be the more more really doing significant We're But is our a we the that. anything But focus to like in our possible. at company believe selling to at this could is value to value, -- not there to because manner. to we to right revenues of cost-effective knitting, commercial

certain than novel that you with utilization collaborate nobody could there ways groups. with like of someone that order could to ways has get that the with to this collaborations explored other tests may rather there find tests, an that between really do else with even we to in have, One some we data haven't partner the parties. be could outright acquisition, new interesting in with asset thing And been you are

things. So, things at things that monetize all to are look we these actively ways exploring as we're

of day, are utilized, others it of about of provide early think we that. days Getting these exploring in do a At and that's the and to doing it. end the have commercialization. very valuable doctors there how the These to efficient a of health robust to pipeline ways And tests. ways we variety of tests to pregnancy We're information systems.

you. Thank Great.

bet. You

any our I'd turn over question-and-answer back to for the closing session. now Thank Mr. conference DeNardo remarks. you. to like This concludes

Afternoon, today. This concludes joining you the call, and everyone. us for thank

for now conference concluded. The has today's attending presentation. you Thank

disconnect. now You may