AWH - Earnings call transcript Q2 2024 | Aspira Women's Health Inc.

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Operator

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

Second Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded today.

Before we begin, I would like to remind everyone that forward-looking statements are defined under the Private Securities Litigation Reform Act of 1995, will be made during this call. including statements relating to Aspira as expected future performance, future business prospects and future events or plans.

uncertainties that upon reflected and to reasonable subject risks believes statements such results the company materially control. to based differ factors are assumptions, and Women's impact the of the anticipated beyond in expectations forward-looking are from many Although those could Aspire due Health and actual outcomes

except of set law. the new supplement whether that results actual as statements, are company differ no information, events on the set factors The on future forward-looking XX-Q could cautionary Form materially assumes most by well and to anticipated in obligations press from forth forth risk description recent any Form to as or annual to directed SEC report in forward-looking factors in otherwise, result Participants release update of Aspira's required as or the statements. filed cause report note a quarterly with as those XX-K a for today's

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

Nicole Sandford

for assessment our cancer portfolio the test [indiscernible] of effort of in XXXX oversea operator, quarter the to launch I with Sandy powerful call on will longitudinal the ovarian monitoring mass. for I with overview operations, the financials at was the opening blood and questions. begin you, our publication [indiscernible] and strategy, before call. development. of followed risk commercial is our conference utility quarter and the President, both for is execution expand latest our of for May. welcome, from following Milligan. beginning the most of will women me second opportunity clinical an by Dr. OVA update an application for development everyone, our product With Thank today our earnings important new Sandy to then data review This development . The watch, the

goal available in and of accomplishment the that achieved this offering long-term in means the are longitudinal is only kind major of This important on The supported we blood test, world. that and a monitoring first with us anywhere company the we suite the application believed who one share journey. shareholders its launch many the life-changing our and have a of of tool

Let's in than We for request XXX,XXX addressable market addressable to that that the tests ovens, XXX,XXX the few our XXXX. watch tests I more market with growth. the December the application to early of on stage over as set the and launch the was of of increased the past per our a XXXX when $X.X the commercially future company in test joined only of OVA available United years total between million assessment States. year in initial for

the our health Now quarter, per This believe with XXX,XXX already the this total of more oversea we and the application is monitoring between addressable increase is times. been launch care tenfold market for that have for the million tests revenue X tests year. in providers potential a million trusted test by than lingual the X

dramatically second increased beyond. mind review for as look performance our the quarter addressable keep to market and the the important to is It XXXX of out in rest and we

well people, the impact began elements that to and of strategy process program messaging a identifying market increase refining goal of second our the and refresh of technology as we with both and You recall commercial in XXXX, as our may half reach. enhancements

first believe as is to more efforts, advantage was our first implemented well I'm with and have enhanced seen refresh half of from we result, the cost XXXX. of take the positioned [indiscernible] Moreover, is positive I resulting are the ever, of we than the happy efficient to XXXX. expanded and addressable refresh critical a during momentum fully quarter effective completed that which to The in report our [indiscernible]. goals. containment sequential And growth commercial cost

XX second field new to By test a field coming in test average XX% test. XX% We with an same XXXX. over suite tests. we when for from volume of total than second salespeople the that company resulting of the XXX in quarter last volume achieved year to comparison, XX field in compared the impressive X,XXX half high increase an this in Our Overwatch of the this period volume had sales the quarter had salespeople with fewer volume of watermark representative year, first for more salespeople to full-time XX% compared of field

in expect new along programs, powerful data test We added to May salespeople field X rapid additional in quarter and commercial application the these [indiscernible] expanded of the published and with support the third in territories. success an the enhanced the

Our care standard of now every of focus adoption drive to to universal primary for test diagnosed [indiscernible] portfolio become is our with an mass. the [indiscernible] woman

with for this added working protocols our to the of the important to tests mass year. partners expect many we together are care, adnexal There and come have to underway, quarters fourth including which in initiatives third

in rely our I'm and our ability increase on made. to success products, coverage growth proud the of commercial oversea Our for progress we also and reimbursement have

Northeast On commercial [indiscernible] labs. side, recently Anthem Plans state, contracted in adding we X the California with the plan and million

of an Virginia the Illinois of lives. would [indiscernible] Cross add geographic and Superior Texas Anthem end additional We Cross this million have we complete regions before central to of Shield XXXX, added contracting Plan Also note, Taxes, year. XX which Blue Blue expect to

test Advantage our XXXX. half the reimbursement critical we Medicare Overwatch for and more side, second Medicare and increased quarter. over Kentucky California, X in Illinois. On Medicaid meaningfully the also suite the bringing has in of of New number York first including states Maryland and X, total or the covering to the added of states of

of clinical We women to May with Overwatch model momentum created potential study achievements, benefit if The and interventions We helping in from instrumental national the adding result a Overwatch adnexal data Despite payers can reimbursement accelerate are reduction to a analysis experienced comprehensive significant published do The clearly further to is mass. our these the demonstrated initiated and quantify believe more physician's our circumstances a the third-party with with integrated network know in help progress, additional consultant. to that depend the we presenting pass have convert we of patients To savings we will was the to payers. swing a in have way. used. we savings low-risk assistance compelling. regional on payers both and potential on delivery surgical assessment an

gather to and coverage support the to The must objective need specific requirements reimbursement of we and insight broader Overwatch. project evidence is regarding direct for

that expect the XXXX quarter complete interviews consists identify for study launches. be GAAP, will in the and for stakeholders commercial reimbursement future we into OVAX evidentiary to sell. we will expect to a other and with of Overwatch incorporated while also informing must product The coverage access clinical These first phase third findings strategies we help of study, expand senior which and our utility market

Now it position. is to performance back about the I will on Then my over balance and to to development. pleasure turn come sheet call Sandy product discuss Sandy? to talk our operating

Sandy Milligan

we role share our the programs. you, pleased continues as the development the have today. I'll my progress made and with of which research In focus President, quarter, Thank I'm in second product you to acceleration with be Nicole. my

these announced physician their for for demonstrate as triaging and significantly we cancer of mentioned, use peer-reviewed the over an the of publications Overwatch publication clinical surgery improved focused May. alone X assessment serial Nicole As malignancies of Together, tool. the potential in supported overwatched ovarian impression manuscripts risk

the malignancy women. low-risk for performed especially risk, risk malignancy data demonstrates and premenopausal surgeries out of number asymptomatic women of reduce and concern Indeed, have XX% for in in This all and reduced that with patients by substantially premenopausal XX% surgeries women. Overwatch patients may could for in low Overwatch

or monitoring, the clinical prescribed of low support Overwatch clinical intervals and mass date. the drawn active serial Overwatch feature its patients physicians by for proposition of provider as determined be an risk. assessment This is value for for added initial to adnexal can strongest and With surveillance mass at indeterminate

progress February. Reproductive to insights to data biomarker Let EndoCheck endometriosis upon has with the identify of update EndoCheck, our will with endometrioma, believe development including to for health significantly discussion on our certain Scientific understanding as a robust to brief disease. Annual our protein-based care contribute Meeting presentation the located the with product following that offer protein me signature overview a test devastating that a We EndoCheck this Society well the complex in now of improve at shown as been broader turn Investigation test of our applications ovary, endometriosis and on providers

as opportunity currently processing this clinical quarter. will collected to have have are data potentially the response drug may nearly during This to partners. development development potential new with a analysis to to We outreach therapies in assess data could expect study or pharma With our we third the to identify in the expand EndoCheck of for drug endometriosis trials. application research-focused that and commercial patient track in further and our test hand, clinical test ongoing XXX in the include samples companies therapies utilize

score considering an adoption care endometrioma our the to Overwatch collaboration EndoCheck test EndoCheck we majority portfolio. testing molecular in We are presenting We how on and provider [ clinical this do an have allow indexal women in the which With positive our let now turn ] for Farber believe to ovarian Institute. with of towards Clearly, proceed and mass. the test. Cancer providers addition work impact risk would have our me have of deciding the with of the with pricing and to to developed health resources also report being to how assess both is may focused development Dana a OVAMDx, cancer of that, best for utility,

system, utilizes which technology on have on a microRNA feasibility an Dana to diagnostic analytical milestone, assay We confirms Farber test by a a platform. critical commercially the perform viable that ability PCR discovered FDA-approved that completed

end verification XXXX. next Our prior the data provide expect we is process, additional is which underway, assay to the which and phase, of design to currently

well have for cancer various As as subtypes with testing adnexal we for believe position as will that detection to early-stage we sensitivity broader masses. noninvasive shared this test solidifying ovarian cancer for the in women leader previously, our have power histological the as improve ovarian

identified complete we with of and development protein microRNAs steps into our our the will and test OVA development leverage agreement Dana the for broad from the developing endometriosis learnings we program, As test biomarker EndoCheck through Farber. blood in proteins general research microRNA proprietary leverages a MDX that and experience

as of and We are this broader the microRNAs design working protein selection test test. of for feasibility endometriosis ongoing analytical and establish the to candidates part

the that and role endometriosis. Now ovarian and FDA tests molecular determining the in are both regulate cancer related for in-development to finalized process pathway of our regulatory requirements we for the has its lab-developed tests,

regulation the on to application significant and impact anticipate not of protein products, ability do our launch to to microRNA longitudinal development nor extension a biomarker the have or We offer line cause testing tests. our anticipate prior of combination new for existing any do Overwatch the role time including we the

on funding We multiple continue from of activities, focus R&D funding identifying our for including sources to research nondilutive grants.

related aggressively pursue. opportunities tests development believe our created that which intend new we Our to has research to are groundbreaking. molecular We in-process related grant

for In consolidate addition, outcome, sizable until and bring the we development such requires development is the of are which and strategy to commercial opportunity, helped us grant compelling decision potential Regardless application confidentiality to partners. waiting on a to funding a made. data-driven a decision have processes

of baseline we of samples to an Another our step with division. for for we samples executed diagnostics. average nondilutive plasma sample. secondary the value serum that disease July, is where material utilize market as funding who another number for showed realizing recognized cash per in sample research research. In as potential have $XXX through opportunity our an validation of approximately This blood parties selling Biobank, important analysis We many third the purchased a a available gynecological through of non-dilutive material transfer price and whole establishing agreements source and intend for XX,XXX small is recent

requires bank. progress We and from additional XXXX. also Foundation our tremendous for be may believe right that that strategic identify benefit there a to access that sample the in this Finding initiative have made research and health to work complex we approach to could with path is activities academic opportunities women's in

With that, it back on let me to Nicole? Nicole now for update our financials. turn an

Nicole Sandford

a of [indiscernible] and Sandy. you, from was the first quarter to increase quarter Over for year second sequentially Thank fleet revenue second XXXX. the flat the XX%

increased to and increasing contributed significantly volume product XX% XX% X% Overwatch of X,XXX, test XX% year-over-year. sequentially and quarter overall growth, year-over-year. sequentially volume Second

the million to large earlier, the discussed critical of I of is addressable As the Overwatch market given contribution between tests million year. overall X to growth per [indiscernible] X

the a adjustment X% $XXX year year. accepted generally to sequentially reflected that Our in an in a It but this and from was quarter principles compared for actual accounting to required first overall last down note price on quarter prior under compared unit $XXX collections in change $XXX, based estimate in previously revenues. second slight is to important AUP quarter recognized our the increase the

After increase X% increase ] XX% as XX% decreased Margins adjusting second up XX% to shipping half compared for have per a of first higher including our of compared in the X% see with increase the an last test, year to the XXXX. last a product XXXX in would AUP this quarter quarter saw costs. compared year. this $XXX increase than Overall, sequentially, AUT converging to slightly second $XXX been costs, higher quarter and we just second to OVAX. year pleased this for we impact, are all over AUP OVA quarter, products Overwatch's to X% [ to

exploring ahead to year. consistent we with costs Gross for to is are X currently shipping control look margin months We as the better XXXX. the options other largely prior

expenses must increase primarily molecular side, process personnel portfolio. year, samples, for the the increased advanced and marketing for supplies with for operating be research well which and to marketing we salespeople. as increase inside prior testing. due development to the This partner test purchased our addition in professionals leaders, On quarter research reagents collaboration an of quarter over includes second in XX% costs and of expenses the Sales the required in saw account other an strategic increased and the XX% year-over-year costs

to quarter due and in this year, costs. personnel to XX% mainly compared last decreased decrease costs a G&A consulting

cash have to for increase related the cause since in down amount XX% themselves increase One including mission the was decision outstanding quarter, achievement to slight $X.X in used During a and used prior XXXX. sequentially of of compared dedicated had cash strategic X% critical our retention the operations our last second was been million, to year to small a individuals pay our our bonuses over and staff, the of our year. the goals. that These to is

replaces would million. of Our been kind were HX which ending facility standstill gross [indiscernible] [indiscernible]. cash for the suspended warrant the company of entered pipe $XXX,XXX. the in be available August, to under small a XX-day significantly cap June This arrangement and We believe prior including our a subsequent variety following of $X.X with a new for time. the we cash as this have inducements July, for million lower for cost completed has a [indiscernible], agreement offers After XX, into warrant of some facility was facility, will with been for XXXX, which inducement $X capital. approximately In the adjusting of that a alternative reasons, at proceeds market HC approximately a companies better

opportunities term. will for fund of in change the have us for newly the partnership We grant year. million, We including towards believe cash at in-place remainder [indiscernible], for and Sandy to are $XX.X that facility operations the we guided to our that of of beginning in XXXX $XX the updating our compensation million year. also operations our to be and our Today, sample guidance million for initiatives, the between opted down used base I announced the availability $XX million $XX and from sufficient we ATM near sales to be executed and the

in of Each in salary. additional us receiving XX% will exchange cash-based a equity reduction for be

up a stock markets company's We enough rewarded with We continue potential. to capital undervalued. to is believe when be that the our to alongside shareholders the want our significantly position be in catch

to for our success. women long-term for while improve challenges, we this [indiscernible] millions outcomes health ourselves While focused many year positioning on mission of remain presented has

and the only to have the tests malignancy our way the and ability. noninvasive test for that have the to of endometriosis. and our risk our accurate the we on be on have mass, We of bullish shareholders to assessment patients, diagnosed adnexal proud market for all development of promises continue in patients the an physicians that I prospects, in blood kept I'm been leading the we with best are our

update. an as brings Officer experience to passion week, of for August personnel Chief have open the decades a an financial mission role. our and interim appointed This Board John [indiscernible] for Financial exciting John Colosi, executive the I our questions, experienced Before I XX.

Officer, senior of Officer, including served our level Strategy [indiscernible] to undoubtedly well several help growth stage Operating and as businesses. We those have future will like in Chief roles, success. Financial facing Financial challenges John's in at Innovation position Chief expertise Advisors for us founder to as solving critical

I and base. as to Operator? call refinement open shareholder questions. priority first our of would With now the as for well strategy liquidity that, be our capital like the expanding His will

Operator

[Operator of the first Fitzgerald. Ross Osborn Instructions] line question The comes Cantor from with

Ross Osborn

Congrats the on progress.

on for utilization versus quarter, up really volume [ starting attracting growth the between your parse increasing strong . quarter. out by Would existing new you customers So ] DOCSIS portfolio?

Nicole Sandford

question. for the thanks Ross,

I to think across both it's been be honest pretty with you. categories, consistent

So we bring existing to see new providers continue provider continue adoption. in growth and on to

Ross Osborn

to versus good the watch submit to around you please. hear. going FDA regarding oversight think impact And LDT. you we your is don't then if classification And again, offerings. That's for to process your walk plan current realize Great. FDA's Okay. through a that But comments still do approval? I historical

Nicole Sandford

I in. you Yes, know to want that. take if Yes, don't Sandy, jump

Sandy Milligan

sure. Yes, Absolutely.

LDT additional to we year. year what as Ross, So we're data move cleared we've At FDA. regulation LDA before approach we and come point, to this this considering not the FDA been to were we at anticipating forward -- because utility and thought with do want initially clinical get we sometime whether or Overwatch this regulation holding the

companies before we if effect. for came is LDT can have LDT the because now. leave to And Overwatch regulation into forever was until an to But to do released the So leave we do probably so. as as want aware, we clear it, it -- opportunity got we're Well, going have it you're

an With before have then to the mid-XXXX. clear new LDT, just as we products, we can and release

Ross Osborn

Okay. see considered And Nice the a . Perfect. John then classy, he hire? full-time to lastly, be for interim appointment. on Will

Nicole Sandford

but point, an will for interim, a we he's . of as in we At term. CFO long for term this to been long have need keep open certainly, only obviously as brought will the options all our

Operator

from Water question line with the of Duke Next Tower comes Research.

Unknown Analyst

on Congrats quarter. the

Do know longitudinal potentially Overwatch. occur? on growth you like of to rate? in as physicians Or more we wanted growth I its just could you're about the monitoring. envision see a step-up Just thinking as growth how a steady implement retest

Nicole Sandford

Thanks for the Doug. question,

So proposition value testing looking as part I'm big launching are of it would have as the at that familiar them and has products, are been A market, meaning in trusted introduce we past. the we our used into a warm for portfolio. already that with be providers it new existing that and

So But you believe we faster will ramp-up that historical, saw did I when back ovens. we seen have in we we we Overwatch see OVAX launched. over was for see, it steady nice since launched than a if look growth

I will to . same, at the I much be be believe least faster. it but do expect So it

Unknown Analyst

any And gotten know. with on have about the anecdotally, for just to feedback Overwatch. Good the physician publications you mass level monitoring of enthusiasm and

Nicole Sandford

really intervention has cases, very I with things more of pre of one recession utility were we benign test that potentially Overwatch, the how providers menopausal on information about we The masses. since reducing women in show it benefits is women. versus were versus And positive. believe that launched provide actually symptomatic been both in to the women post able the learning interested and surgical asymptomatic that for

categories. those of all in So

for women out removing for -- fear other malignancy identified something goal or diagnosis important to and maintaining another really So for you're of mass who them when through for their as ovaries also where has asymptomatic ultrasound premenopausal some a that's another Hopefully, of clearly prophylactically else. incidentally of kind or to transvaginal identification is opposed women clear. looking

Overwatch with utility wanted additional longitudinal the we application brought But particular we've very as help the populations. understand past helps of along them the those these launch test. have because the received that in doctors categories warmly forward them where in new would of how are X been heard some to information to monitoring result And data the understand that the has a really

Operator

Next of with Sabieth question Resource comes Partners. from Laura Alliance the line

Unknown Analyst

quarter. feature to have here to do the to oversee, monitoring on to now next you The the suite? as and longitudinal you again growth add mentioned what Overwatch, this potential score current further And in see any also Congratulations up? the do [indiscernible] plans enhance implemented over you

Nicole Sandford

next for the The -- for step thanks question, way. the by

it's monitoring, longitudinal all for step adoption. about Next

be with could out sort Elias, bringing [indiscernible] being the have of value or higher discussed able score improving to an suite out partner actually for past or really the we're understand do expansion back women's in and of test at suite. even talked who We our longitudinal there over held the R&D enhancing is possibility. they in a determined sure the either see that making -- a and on one physician to ovarian an This going physicians EndoCheck the cancer and rule to table So single he tests over of to benefit test. our for actually suite opportunity and over about of in Dr. the we to earlier endometrioma, was monitoring. that proposition webinar with the And think give rule to terms win used

us Sandy samples crystallize will that. development vision the EndoCheck we the brought testing right now of very Overwatch research a experiments from in score. in the check and have for and the any step, instrumental commercializing about is to The certainly, our EndoMDx test. study we're be next enhancing that on regardless make But third in product. of decision the design quarter with as doing So to and some mentioned, -- really we're additional data clinical help additional running we'll the we EndoCheck

Unknown Analyst

Milligan. question It -- ongoing just research the PCR And digital another forward to. it. was the for I Got past, in mentioned PCR look on maybe Droplet the then platform. Dr.

on as other And speaking? plans . encompass? of well it what opportunities you as are So platform leveraging see what this here overall some commercially is any the

Sandy Milligan

over our I our of now, scientifically, at seeing we're we're you for need throughput sense. think that multivariate to the Pappas, an do some platform. on in the platinum forms, -- just to especially looking date We advantage satisfied has microRNA. other it the it with with particular the very that Todd deep we scientists, right commercial So but Any our with performance are connect

Operator

[Operator Instructions] from comes Next question William of Brackmann line the with Andrew Blair.

Unknown Analyst

This is on for Maybe can give start just bit Maggie us a utility more Overwatch. that how you color to you're clinical about study little for Andrew. thinking here, on maybe

Just anything in terms eye of size, timing or to end points keeping be that for? might be an helpful out

Nicole Sandford

Yes.

first them study about enhancement get So would payers our allow with the is the of medical for decision to policy clinical gaps an to makers the are move from the the the test. to forward data some additional that phase clarity at what for

gathering some doing will of end So those at be help the going to front to we're questions. answer that data

We right? that So a to a cagey You're they another that XXX quarter be well, I'm is to know commercial as but XX first in there's here, that, need it to find maybe the Candidly, to trying matter them dealing not is top. lot, not what XX be much not maybe as of but XX now single space, see. important us payers it exactly answer. going to matter to as different for with

of views of payer kind test in of So the terms the for input. opportunities the we larger prioritize to have

much quickly how those gather will data, how is us take? to to answer it how much for the very be main the will How it questions, we will quickly objective -- that long can responsive. likely So and do cost take is to going it long so

Unknown Analyst

sheet. just ability into then And the your further your implied you do boost the product have? and with burn the going burn around and just in of have discussed then . updates forward, to earlier financings nondilutive is million and on view call when about sustainable expect cash with us particularly pipeline the you as reduced visibility you $XX your And recent it. can Got to update guide balance thoughts the you you funding, that What innovation quarterly there.

Nicole Sandford

Sure.

So the in point quite but have, an financing, for ball we opportunity that's at terms this but to opportunity biobank also important looking partners something get look for it also is moved to data. quarter cetera, and terms physical we've nondilutive the that lock our can and required forward a opportunity full to not partners this on of offering a us tests is, That's nondilutive arms looking including for people assets in the bring include financing, work with . bit collection appropriate other commercial of to documents, development. of of and the et monetize taking can right we while where legal to which inventory a essentially the quite to collaborate our expand importantly, to that the just of either or with kind who an look because in sort

from this was that So few quarter. forward an important -- steps very important

opportunities with grant mentioned, of on lot of decision-making process, applying them say molecular as we've than throughout of place the have value that standing such In progress sense, makes on been lots [indiscernible] and different to a time just at can't comment test I too grant where we've for been made microRNA many so combination other different out asking Sandy require in of addition, today, data we're confidentiality we're very the to just in where we much that additional portfolio. great the funding going versus point past. protein,

So go sense for for and opportunities. those out look it great makes us to

Is there I a answer? the of second didn't part

Unknown Analyst

going. keep Yes,

Sorry.

Nicole Sandford

second unless I that. asked just remember, you No, answered think the I to I'm trying question,

Unknown Analyst

or was not... It just No, no. whether

Nicole Sandford

Yes. Yes. Sustainability.

where year-over-year. spend. So I the have CFO. continue my the in quarter that, we to reduce my believe quarter, with and slight that the the many many, to increase. quarter-over-quarter, where burn. look But goal in It's in years we do specific . were really first help this continue reduced back that second increase ability we over I've intend cash worth time when mentioned, quarters I if we burn last the you of do to been is to X.X every made role, investments new I some our that an were demonstrated that had as many, a in we there And have to

Operator

like at Nicole There floor over are time. . now no I questions to this comments. further for the closing Sanford would to turn

Nicole Sandford

you, for thank joining providing at everyone, earnings We update and another call. to quarterly us today. much next so Well, continuing our look our forward execution

you, thank . So everyone.

Operator

concludes Thank teleconference. you. today's This

lines this may disconnect Thank your you at participation. time. your for You

Aspira Women's Health (AWHWW) 12 Aug 242024 Q2 Earnings call transcript