Sera Prognostics (SERA) 8 May 242024 Q1 Earnings call transcript

Good afternoon, and welcome to the Sera Prognostic Conference Call to review first quarter fiscal year 2024 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.

Thank you, operator. Good afternoon, everyone. First Year Prognostics Call. Earnings Sera to Quarter XXXX Fiscal Conference Welcome XXXX. the today, the results XX, market of quarter Prognostics March At the financial Sera close released its ended for Zhenya Presenting Lindgardt, Aerts, for CFO. today the will our President CEO; and company and Austin be

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

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

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

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

Prognostics website. CEO. on call will the As President Investors a now reminder, a our Sera this Zhenya? to be replay webcast I and Zhenya, over the will of section of call available turn

Peter, and you, good Thank everyone. afternoon,

margins. in with progress inflection in for and test We continue improved revenue in place growth, make keeper volumes putting requisites coupled to

the is we position As pursuing in we Austin Sera, manage increased will ahead, business for strategic future our strong and position with we development cash while as goals growth. sheet for balance test preserving to the are adoption XXXX quarters for diligently a foundational company of believe year the detail,

study to results benefits preterm care help our These include new our to methods capabilities bring focus of strong R&D goals market, economic new the strategic product products afford test, our the for to once showcase publication to of the and improving demand pipeline to and increased continuing health access clinical building our inflection well products on awareness improve patient health PRIME to outcomes, and and as important in AVERT equity, our collection occurs, our margins while all better lab as profitability. and scalability of

the interim strategic of of progress our priorities, publication, kits to PRIME these shifted to whole shipped blood submission year, made Since we've across collection the customers, more including study beginning findings a for first and COGS cost-effective increase air analysis XX% to stations public laboratory process, scale, surrounding awareness which at resulting network estimated savings in on year programs will television X test birth. this later preterm prepared an

PRIME for data remaining PRIME planning the also participants, enrollment X,XXX enrolled in complete, now who Deliveries were for the of analysis are XXXX study publication. DSMB study recommendation now we're and final December the and before stopped

validated customers. have and shipping kits ambient new whole our we have We're that to blood pleased to report collection begun

and capacity several expect collection are blood goods. reduced in laboratory primarily distinct with together lab our through expected We to decreased of coming weeks. of and the turnaround laboratory see kits cost ease start to whole running increased collection, This, our enhancements, yield advantages, time,

Simplified in leverages the processing we orders to rollout patient an simplifying of greater which providers. with collection enable the samples more mass of mothers and newly improved patient that user laboratory collection us for our lead method, to provider. across The will really spectrometry. to country. process by proprietary allow repeat ordering the and validated physician expect experience our means used also antibodies to is reach test, process the for the friction blood improving less whole should believe By more coupled Sera access We

processing of increase our for throughput this affords about an to specimens, laboratory fivefold turnaround enabling approximate In whole new a addition cuts blood in improvement the technician, time and sample in tenfold technology an by XX%. processing capacity approximate

addition enhancements, faster a shipped when reduces labor In be and process ambient while material simpler compared scalability reduced laboratory to and serum. drawn capacity and cost frozen and costs, can blood to whole at a samples much

beyond to certain estimated to increase to our margins we up These goods of improvements XX%, to possibly cost an strategy. expect of access growth our a our key should scale Overall, prerequisite to serve reduction milestones. higher technology,

to PRIME preterm of validation adoption. work birth utilizing believe points for this attention bodies and for communicate development the A recent complications. on guideline of guideline and setting will While on note our data test studies, testing the biomarker preeclampsia to benefit strong we guidelines ACOG AVERT from the to from we provide preterm

providers improve include we're by stakeholders now, teaming maternal to adoption in pregnancy rates. the hit various to states For with continuing These to engagement test hardest outcomes. with birth premature target order stakeholders of up we're and spontaneous our increase

providers other preterm to a working big equity and of could problem the to Our stakeholders address and communities. adoption physicians provide awareness premature spontaneous pregnancy to community patients, payers targeted overall. and care, resolve broaden state with health with and increase in a promote and births medical particularly and plans populations This collaboration undisturbed programs on by among way include improve implementation

whether that of FDA's of Congress higher for a we with the could safe into under a approval A new a changes been we reasonable FDA's often LDT Valid and be new review of rule of laboratory of And pushback higher and entrants keeping called a industry bar patients tests, share the new for or space LDTs. has FDA interest the week from level in its final LDT pending review final rule last the published oversight been set stakeholders, for impact developed goal while, there serve. on XX. There in potential may tests, of subsequent lot the given certain The April LDTs. Act while has

a framework our bringing but uncertainty well may FDA's tests to be challenged, to we are patients. whether placed continue There's proposed new work to believe regulation the within we always LDT

example, the enforcement State for our York continued For status LDTs Laboratory The New which discretion. new preterm approved LDT test. quo Evaluation preexisting includes rule Clinical by Program, includes the FDA's

extensive years for long-term our clinical data, believe we as history R&D-driven strong a and to competitors bar dedicate by of regulations Given significant serve and study could advantage requiring stronger the by source higher of work investments. set Sera

our help representation may oversight increased equity which help that studies, which with states advance and adequate in validation nicely would promote lines mission. up health FDA

at of XX.X% about XXXX, in rate racial according burned reminder, remain. preterm is a United CDC and for prematurely rates to babies X XX As States, differences while in in ethnic the a birth

higher preterm. For rate of need to do than with more, XXXX, birth XX.X% can about among women, the was women rate birth or African-American preterm of we at X.X% respectively. Hispanic preterm and of XX% white the and We among XX.X%,

tool in this education will over is be these expected a awareness for Sera was of XXXX expectant invited programs, this recently birth. X Distribution launching year, physician of physicians building Sera will innovative Ryan. Later Viewpoint Sera people campaigns to the Empowered million on broadening understand XXX featured reach awareness to the of be solutions Quaid support risk Dennis follow available United their preterm and mothers This in to the we're Meg summer. to programs States. to and with strong television with

is Outside States, test expected the exploring This in with for a process international addressable of births to compelling. current market of premature engaging significant the our we're countries preterm United Sera involve in attractive regulators market with markets. core the number is where

Upon publication of our studies, pivotal PRIME regulators. we AVERT share to plan with and data the

to multiple engage are we healthy enter expected collection what to product international our on accessibility to health promote to to plan adoption promote We while test needed margins. to leveraging markets, whole blood ambient equity potential assess enter ease ultimately market methods may optionality have care still address be also with and markets. partners key kit If access, such cost

Developing test ELISA to internationally. processing easier Sera also would go make market to for it via

and goal such as multiple embolden of In pursuit only but to mission. our I shots and and become on pathway preterm easier will study, bolster of believe to our the in pursuing validated regard data also and build publication mentioned, awareness will adoption we're compelling upon conclusion, the not

you, over Austin. Now to

afternoon, good and Zhenya, Thanks, everyone.

me our and investments. then on quarter for financial briefly the commercial review results our thinking Let review

revenue was XX-K. to the XXXX our due process, recognition through revenue collection revenue normal quarter our described of first our periodic as nailed Net updating revenue amounts of detail part estimates adjustments for in of made expected as refinement in

for prerequisites first Gross once to investment our for quarter of approximately $XX,XXX $XXX,XXX portfolio an our we activities reduction the XXXX. on to executed optimizing commercial evidence our deploy built expected outcome for This revenue adjustments and capital and preserving future of in is in revenues other commercial before investments have were compared success.

runway. rightsize to last cost our year structure materially decision improved Our has our cash

uncertain the foster highly all we validating coverage, of we As key XXXX. was previously revenue our physician as such an the immediate that awareness and publications ramp and would it and insurance achieve preterm requirements test, during adoption consumer first could half noted, that of

you are prerequisites this mentioned in to quarters. half in with coming execute these we this of share the in As the news of call, Zhenya to diligently working exciting first year each hope and

down to million, $XX.X overall $X.X first we our due $X.X a quarter XX% primarily of and first down million commercial million XXXX. $XX.X better Net the the million study focused development from for quarter took million ago steps of XX% from loss for for streamline was quarter for expenses operating and expenses. expenses XXXX of due costs. to quarter operating $X.X first strategy $X.X were period the Research for first the clinical the Total from to down XXXX of lower XX% and million reduce same year operations, were commercial

for efficient and million, from administrative to quarters to the due a while expenses to down steps ahead. general we've taken means quarter build first period the revenue focusing XX% on $X.X the expenses the in same the $X.X for most reduce ago were year million Selling,

are are for expansion planning expecting previous and not operations market expense generated our into invest quickly we immediate prudent any while to commercial appropriate. of when opportunities to we have commercial return by an awareness We levels, begun a increased publications prepared study and,

regular December partner As by company operating received primarily improvement equivalents cash XXXX, offset the from securities was million cash a resulted strategic expenses. an of and of payment at and of January, $X.X cash, available-for-sale million. XXXX, XX, had our $XX.X This March over in from million approximately $XX.X about XX,

of of We continue cash and the rate uncertainties and environment. the burn our future capital current markets mindful be understand to

investment our the remain strategic diligent in believe strong the company fiduciary for in we cash, balancing this and progress of quarters We management years ahead. with and execution commercial that will position will

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

the will Blair. Ladies answer question line comes from question first gentlemen, Our of and you. Instructions] from we Thank now [Operator and William the Brackmann begin session. Andrew

is This line the Dustin for Andrew. on

updates you're published KOL analysis? with since on PRIME with that positive latest PRIME the any question you update of kind as First on having conversations they'll sort DSMB. after gets you I -- interim well? or what bodies just And have, with in the conversations the very shortly statement having think And publication do with similarly, then of guideline give are

so is Zhenya. This you your Thank question. much for

You're absolutely right.

far results. as closer soon as In We setting last and point details share are the we them with guideline KOLs wide publication, members, of bodies, of and professional we the all are the our the regulators. -- with with to society will engaging reconvene to touch was

to so something breakthrough that do engagement all any we commentary can't level their guarantee the far that, absolutely signal on to but certainly of developments foresee do I that issue update side. or interest will that certainly of on investors they will points setting front. from and their And It's bodies some guideline results.

on question pipeline. A Understood. the

what time this can is birth in year next the or assay to I you where and terms said generation? we to think then for in data birth. development maybe wondering previously time of Just expect some data year now,

as product enhanced birth That's speak. we Dustin. to time right, The is getting

our the we I really put will for data step product. As on it the Certainly, platform decided available economics on are to ensure in as mind the be launch. to product data of ELISA on this there sequence first strong making that mentioned, --

before is the have that suggested But your in would a happening what as end that the as I I shortly precise on time or early you coming counting months. year for of that. -- expect for line that before certainly, the on don't year absolutely So next timing launch. the question, in

on would expenses top previously, those And know helpful. one an of in from baked that be you $X million in then option the That's that of today, is Okay. Is part guidance. about additional investment Or context $X marketing I talked X just that? that million million? us. campaigns, that you more of you the $X that announced the

Austin, do that you want one? to take

operating a the current and don't mentioned, have budget Sure. actually material on Yes. campaigns, cost-effective Zhenya incredibly or really marketing current These -- impact as our are expenses.

terms mentioned, very low cost As the opportunities reach. these came for us are and in Zhenya beneficial the of us to and

talked last But opportunity we going sort of that in for As company we've and far the as current about We're $X about million to of quite and talked into talked that we're million vigilant. near- run that previously, and $X we dig out we investments of spending how million each sort We're to about deployments. of ROI going $X commercial of of will remain going sort additional commercial pot not the we to majority yet. value time. rate we've the into of milestones terms before invest to that behind our The beyond our the really be budgeted in opportunities. and evaluate achievement creating -- start that long-term

Spot on. X And paid for so basically, baked the Dustin, costs. already are our into campaigns Yes. and

[Operator seems be this no closing Zhenya for to Instructions] further Ms. questions As comments. final Lindgardt to at time, over now call to the there turn back like I'd

thank and today. operator, all attending call much, for you so you Thank our

of for of remainder do awareness pursuing have preterm. in year as launching the campaigns and the We channels through reimbursement, lot paid self-pay well and work education a fair to parallel as employer to

can accelerate greater We of premature helping Operator? invigorated of fuel that in to -- it crisis these turn the solve by our interest to births technology premature conclude publications back the We when PRIME growth. studies AVERT the of and way of I'll and preterm in studies. and our the birth, pave our crisis are expectation published, solve adoption while now even believe the operator help will call. growing for portfolio, over interest

conference thank that this call disconnect ma'am. ask your for today. participating lines. you lovely We you Thank Ladies please Have a you, your concludes and gentlemen, and for day.