AWH - Earnings call 3 2023 | Aspira Women's Health Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Aspira Women's Health Inc.

Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded today.

Leading the call today is Nicole Sandford, President and Chief Executive Officer.

Joining her is Dr. Officer. Financial Chief Hombeck, Torsten After the Q&A. the for will remarks, we open call prepared

Before remind future Reform like statements would Aspira's plans. this we I begin, related statements to and will made under to future Private call, or including XXXX, future as the everyone prospects Securities of Litigation performance, Act expected be during business defined forward-looking that events

information, are that statements actual due company believes from the to results are outcomes of obligation upon events the as except in by Women's to materially Aspira statements, or Health's forward-looking expectations uncertainties law. no supplement Although required such to and or assumptions, based reasonable and company new any differ and forward-looking subject assumes a risks many future reflected factors the update to could impact anticipated whether those otherwise, control. beyond as The of result

notes as Aspira's risk in to to report directed forth a forward-looking results today's filed set on are annual Form recent from that most set materially anticipated the release press XX-K those factors SEC factors cause on XX-Q could report the and Participants description for the differ Form actual quarterly the as forth statements. cautionary with in well of in

At Sandford, call the President I'd Please this Nicole ahead. time, like over and Officer. to to turn go Chief Executive

Nicole Sandford

afternoon, in this to to would conference our to like our Torsten detail. I welcome quarter, review good CFO, it our highlights everyone. start call. We'll XXXX Hombeck, financial operator, third the to before performance and quarter Thank call you, you with more handing from

this with to fee the in our to CMS' pricing beginning apply the preliminary OvaWatch start all crosswalk approved later growth. pricing to will month, test were We As see of OVAX beneficiaries excited request If expected laboratory XXXX. preliminary Medicare in January XXXX as from schedule. approval always, to I'll

Strategy of and Senior have of the and execution following Aspira including I the Operations. as Sonic we a successful including back been Elsewhere and Michelle several at She Webinar next leadership the physician-focused inside launch Michelle high-impact organization Commercial the front, President phase of closely on commercial the XXX development SemaX. recent reinvigoration Vice the Snider roles joined collaborating that of our welcome growth and of of Laboratories physician-focused sales OvaWatch participants. campaigns, omnichannel refresh, over our our attracted KOL on strategy, our

providers cancer. assess and continue noninvasive also adnexal We a pathway into to We talk patient of point-of-care care our about our launched adoption. help OvaSuite provider care and increase their these their risk how efforts believe practice the help test can products masses patients drive aid will health to OvaSuite to

our role have relationships a Development expansion accelerate created new a health recruited Vice commercial Business and President to extensive care with executive We plan. talented of

Elsewhere several territories, implemented performance in have contract sales, new relationship territories a underperforming a around further sales organization. result. of a those in We a and in to as improve culture reinforcing organization turned many immediate improvements seen flexibility, we the commercial with

OvaSuite compared I since months million, this of of our that X% The continued of third of of an XXXX, X We of first XXXX. in XX% increase number with volume. were of versus OvaSuite XX% same revenues an to period X,XXX, record we this tests OvaWatch nearly year-over-year of OvaSuite CEO. compared increase was year, for of XX,XXX the became quarter of $X.X third contributing to quarter the third performed quarter, X% This the track growth tests Product XXXX. the growth the for quarter quarter representing performed

bring sustain new eliminating demonstrates on much renewed commitment unprofitable partnerships drive can growth a by expanded volume territories to lines company sales underperforming The profitable focus and to as and product that which leaner our to and market. growth we was team, driven a the

Turning its increase from AUP our with a on OvaWatch the second PLA second progress. to declined quarter. we Since X% a April be $XXX to code price. OvaSuite began to under unit quarter. $XXX, over billing shown pleased AUP in to unique steady has increase our continue X, average I the our OvaWatch $XXX

dropped ongoing both achieving However, quarter, cover more revenues has not the since margin detail and product shortly, XXXX, in XX%. volumes. as Torsten will helped Operating third on gross the at levels company to to while growth returning simultaneously the in cost containment focus hold in achieved expenses again

Let innovation. me now to turn

in and as Officer welcomed This breakthrough research Aspira where and following first disease his recently, for we career Berry of team. pelvic development. the earliest academic Scientific and the but a in of OraSure biochemistry test Jody health, Officer passionate Not to September, distinguished as Scientific Dr. work diagnostics Most is in our interest Jody way Chief commercial COVID-XX. award-winning to he the Jody Chief Technologies, about only inflammatory prolific joined led quarter, served integrated HIV. he a he senior also leadership the women's that goes discovery swab all back researcher, is and an and

be our to that stages. to personalized risk masses. launched a learning OvaSuite for We provide OvaWatch with of adnexal in patients malignancy progress X our in machine made expand use was designed effort great commercially score test portfolio, to a

those times, point-in-time has XX% physicians quarter. last X,XXX application was now with The than in coming clinical for which a initial been ordered just assessment, of tests more by this first stage

critical I'm application. of monitoring second towards OvaWatch completed pleased a a as report have stage to longitudinal the launch we step that

Our we the real-world and publication. clinical study review paper completed in use OvaWatch is of peer for tool patients submitted for low-risk the a results and monitoring been of have has

monitoring and in as completing process year activities by the of to end of the begin longitudinal expect test final are launch offering planned. the the We

expand OvaSuite Looking other beyond adding OvaWatch, about are we excited modalities to portfolio. our

a Kevin of Hospital, and Cancer presented the Special poster at recently an Director Laboratory of assistant Women's Harvard of and American Elias, Ovarian to at microRNA-based Medical As test Conference Association related we Reproductive cancer announced, Research professor for Gynecologic Obstetrics, the at recently Cancer. School, in-development Dr. Brigham an Oncology Gynecology Biology ovarian

on for Elias Dr. serum with world-renowned adnexal from showing information clinical women and microRNAs the masses researchers. cancer data ovarian collaboration in diagnostic protein combined patient blood highlighted Aspira's microRNA noninvasive with research. identified by accuracy to clinical the his the study of based test ovarian cancer Elias extensive The improve Laboratory academic studies, potential of consortium with

licensing Among other company's of of OvaSuite This basis study proteins is forms findings, microRNAs, the of the the portfolio presentation combination XXX% research stage in announced and under our which XX% of of ovarian population. the the become metadata concluded early cancers that part OvaMDx, identified late-stage to expected agreement. and previously

finalizing a with an to expect of Dr. and will will accelerate agreement migration lab product. advisory Elias. under this validation, validation agreement with experienced collaboration support with team assist significantly test our currently and development, begin We shortly Work of commercial an are launch and platform we which the the

our aid of noninvasive test to blood the Moving first-generation now protein-based endometriosis. to in EndoCheck, detection

on who our was of of utilized the followed rollout a in be to EndoCheck clinicians Upon through test, the have the We we as data. involved commercial a a and been by our publication the with Oxford test to launch small-scale broader launch material study development similar from for and strategy transfer peer-reviewed of follow of continue OvaWatch, verification acquired agreement. University validation sites utilizing samples both validation, will

following our We EndoMDx, consortium higher-performing delivery a test. by and research through proteins of continue the which payment microRNAs test, $XXX,XXX in We made of will July the for being combine second to Cancer collaboration academic a Dana institutions, develop signature. EndoMDx, EndoCheck developed with in is led Farber of parallel sponsored protein-based with the milestone a Institute.

and migration We the are strategy commercial closely a with now the working platform test. to validation collaborators for finalize

we for will Clinical company's of mission products, portfolio clinical Medical Board a Twiggs. throughout development gynecologic an of disease. The of high-impact be chaired Advisory Leo Affairs, Finally, the Advisory Aspira's will of to provide element tools Clinical overall by and and Dr. company's Board develop commercialize diagnostic established input new and guidance Director as the the

the Our owner members Gynecologic Park for Women's Director and with Health Levi Medical Methodist Center. Advanced Dr. Dr. Hospital. Tamika Sea, System Nicollet Consultants, at founder X Nisha include Gynecology Dr. Oncology of Gynecologic Arizona Garg, and Surgeon Downs, Care with

to now Turning excellence. operational

million the recent again, when We reduction growth. vision. sheet representing still XX% sustained balance showing have, operations in in third long-term to support once to while equity our cash to raise with the $X.X year, the strengthened a decreased prior strategic We compared quarter, used our

is team to standard for a a of gynecologic have health, deployment. determined that standard in an set setting We capital care prudent new industry while high-impact

our turn Now to I financial performance. Torsten a would call of review Torsten? to like for the over

Torsten Hombeck

good provide with you Thank update be today afternoon, on financial performance. It everyone. to here to pleasure and you, my our is an Nicole,

increase during to the in increase the $X increase X% ended September in XX, XXXX, same which in the for in $X.X was XXXX. increased period tests compared The the X,XXX X% performed months by period revenue of driven million, quarter, for XXXX. same to OvaSuite million compared an Product X revenue an to X,XXX, for was

OvaSuite Total months XXXX. XX% for margin September to per was September XX, for same XX% months gross primarily period for XX.X% the the ended to the and in profit $XXX period the increased in million compared X in performed XXXX, $X.X of and $X the million, development costs. collaboration ended year. Revenue XXXX. X X% XXXX, XX, was expenses $XXX, for ended Research XXXX, to the months for test compared The same September for X compared due to decrease XX, last decreases period same consulting were to

decrease expenses to due eliminating XX% year. bottom focus marketing same to The a decreased $X.X and results. September compared personnel X XX, period decrease line ended XXXX, for costs, $X unprofitable territories versus improving Sales and due the were million, million, the to of last primarily was months our of

$X.X personnel administrative XXXX, million, expenses and decrease the of due primarily same were last and year. This expenses ended outside months decrease million, legal to $X.X a XX, decrease for period costs. a X compared the in was versus September XX% to General

compared September same in $X.X cash operations restricted the in the quarter the same cash million. was September in and equivalents and XX, XXXX, cash, as $X.X million second for in period approximately was of X to XXXX, XX, million -- of $X.X $X.X used this ended of year. months million year the Cash last Total

$X balance this The million direct to half million. reiterates from we its registered between cash $X.X guidance offering second net for million proceeds. and quarter where company XXXX in in of benefited $X the completed cash raised Our we utilization the operating July,

turn it I now back to Nicole. over will Nicole?

Nicole Sandford

My to clear then plan, meet important to steps about you, with goal our been taken many We've goals. and execution has those on be very quarter. our investors Torsten. focus Thank this

we in both market significant a is we of achievement, some volume portfolio. a and moderate and grew the addressable the The experienced more monitoring will team. the which efficient quarter, revenue paper our leaner third submission sales with seasonal longitudinal While impacts OvaSuite OvaWatch for test expand

other our EndoCheck and products, of development the in made near-term including was progress Exciting EndoMDx. OvaMDx,

In achieve operational addition, we are our goals committed less excellence and to a result. spending remain as to more

to excited into position from of are move strength. XXXX We the

like call would to the I Operator? that, questions. for open With now

Operator

from Instructions] Our Partners. line first Ben Alliance comes [Operator the Haynor question of Global with

Benjamin Haynor

-- schedule, congrats first The for clinical Just on off laboratory on Medicare me. reimbursement, development. fee that the

do how sort anticipate other Just payers? you will quickly wondering out diffuse that of to

Nicole Sandford

to Ben, take you. question. Really thanks does for honest that, challenging some be with It answer time. the to

any full-scale including include are But little approved, with that will is set and to the process decision We blip pricing the materials, crosswalk. updated OVAX to the -- in difficult of predict. and with have, with also a we OvaWatch, a both the CMS process an of when it holdouts

Benjamin Haynor

any thought But are I'd Yes, insights a see there? grand if I know I there it's question. difficult

Nicole Sandford

a I environment just to but a answer, surprised I you're little you there it's satisfying get not that give challenging the sure weighted. I'm with wish could more

Benjamin Haynor

still the if do folks OvaWatch -- understandable. off-label, of run will. kind the now? Yes, previous -- the completely way? were of cannibalization on you What that it its you are kind happened Or folks with OvaXPlus of then course using think And that's that has kind doing

Nicole Sandford

I going that see each people choose to for continue that's we're think Well, the situation. best test to

-- of because we consider would use we about us, [indiscernible] as cannibalization as imagine, you're it the -- not of we For in terms don't you think don't OVAX. really

we revenue we payers, they It's wouldn't OVAX right? with regardless, contracted have were recognized revenue if paid. off-label. Even it's wouldn't -- really it's get So using

So every an is that tests the run off-label improvement over use we of OvaWatch for OVAX.

growing are independently However, seeing tests we both another. one are

think So seen we've the experimentation do behind us. probably I that is

Benjamin Haynor

that you then number Do and I kind gave the Okay. makes any -- think chance? have per And handy sense. the test Fair volume field the QX of the enough. It call by on you representative. on

Nicole Sandford

I it earnings believe do. I because I there. release was need from it to go in pull

Benjamin Haynor

I must Oh, have sorry, missed that.

Nicole Sandford

[indiscernible]. -- I it it have to let I don't for can apologize find me do but handy. have that, what handy. should I I

Benjamin Haynor

And expected Got XXXX. Okay. the right the of be then volatile release in What's is Upside? Downside? there? to terminology way it. kind the for per to mentioned the lastly Magnitude? during press revenue of me, you volatile think test

Nicole Sandford

to because little question because kind challenging another collections of some of it's answer you're enrolling timing on on So working a it of depends orders. bit

I Torsten, anything predict, we to you would in questions. mean, is addition to by can challenging definition, add? that, that [indiscernible] right? volatile, But

team Our has great a job doing all been year.

available revenue to of us, capturing. that's dollar every So they're

Operator

comes Our Brackmann Andrew line next with the Blair. from of question William

Dustin Scaringe

line This is Dustin for on the Andrew.

First, on EndoCheck, progress to hear on there. going good

laying been wondering out you quarter. that's what guys metrics And And the see has said to launch? successful? of time just kind going updated then for the to Just what launched, use is think goals for when there? previously that fourth line are the you launch yourselves what I this are you

Nicole Sandford

Sure.

the time today. any So line we're of changing not

with launch and development been year. has we was what offered focused were We're commercial end for physicians the primarily we're of similar by where being OvaWatch, where for familiar of who a the provided to use rollout, validate time continues had goal of technology. test the period the on still have a be able test to fully OvaWatch of Our the did to a we to the that, and

on of launch playbook planned planning of next in same We're That's the following, commercial on doing year. broader test the really a with first-generation quarter the first the much been thing. we

Dustin Scaringe

then Understood. in that proposed being How how great see pricing you And to actually And longitudinal you in then the would of are there there? product, all, guys influence that with terms on at CMS. got finalized? monitoring the guys rule confident if OvaCheck,

Nicole Sandford

Yes.

final, there don't reimbursed to that expect that likelihood crosswalk longitudinal be we becomes impact preliminarily at that was We at same level. So it rate be the on will believe would test any The approved the monitoring. the the that test I high. --

has comment. holds the the ultimately period us. behind pen. comment -- CMS However, is The submitted a We

crosswalk that very for terms the almost we analysis, the there's in confident a I they every case was our at the in request the very, look you of in were the mean name We platform, it. put factor favor that crosswalk. process, for forward

be. and it possibly We next the letter, strong case as was in submit as is final weeks. So the several could did the a expected comment

Dustin Scaringe

looking Understood. maybe 'XX. And then to out

high couple can and points, price know new Just you're any test going how that high-level thoughts to at level growth. ASP to quarter you on give there the have compares a launchings volumes I and different of results? us but anything third

Nicole Sandford

point, Yes. We're not really but trying. in a position to give any XXXX thanks guidance Dustin, at this for

Dustin Scaringe

it Spending a that. extend a Yes, And And the yes, about runway? thinking across give been done how But one that? lot any has thought organization just you guys are about are thinking I you burn, shot. in just more. on obviously, help to how color

Torsten Hombeck

Torsten. Yes, this is

USD of the guidance million terms and we our burn in X to cash million. X in So be runway, reiterated between operations guidance of -- in use have second cash this year cash half USD to

as We and cash, That third $X.X of in our XX total the cash first restricted quarter a quarter. million. million have and $X.X includes the was cash the burn up X.X to million September of for USD cash in of the in $X.X second million and quarter bank

other constantly biotech going So our can public is down company, And going looking cash see we to dilutive we forward. funding burn, focused to further what as quarter-to-quarter biotech the that very and non-dilutive fund you a company bringing basis. companies, on that any controlling forward on be mechanisms definitely ways are continue into

are that high to true from to the is help line then X as line. ATM We do are credits. and very they one instruments, us. equity other days Lincoln One And not with volume available is definitely that while funding Cantor company reminder, Park trading a dollars the on have, these of draw with or certain

have, we fund forward. look So continue it's a to into various continue safety company ways that to we to net the and going

Operator

to closing back hand There for are queue. like no remarks. Sandford the the to I'd questions further in call Nicole

Nicole Sandford

to the wish in Thank today. again all you participants Doug, forward holiday Thank of you, year. look a connecting new all and for thank joining wonderful our you. you I to and Thanksgiving of

Operator

Ladies and for teleconference. this does gentlemen, today's Thank participation. your you conclude

time, a disconnect have your wonderful lines at You may this and day.

Aspira Women's Health (AWHWW) 13 Nov 232023 Q3 Earnings call transcript