BEAT - Earnings call transcript Q4 2023

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Operator

Greetings, and welcome to the HeartBeam Fourth Quarter and Full Year 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking.

While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially.

You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. light that publicly not any release these statements mind revise ourselves revision in or forward-looking or information our the in keep we obligating are to to future Please events. new of results of

present we our relating may our to that important predictions. factors Throughout today's attempt some discussion, affect will to business

You XX-Q and complete Factors. more these factors for other heading review particularly discussion most the Form recent our also a should XX-K Form under risks, and of Risk

crossed results available these wire this Relations detailing of is release press website, the afternoon and in section A Investor the HeartBeam.com. our company's

Your host Consulting ended for quarter and today, Regulatory Rob XX, Executive present Financial Branislav Vice and the Deborah fourth XXXX. Affairs; will Officer operations Chief and Eno, President, Vajdic, December of year Castillo, Founder; full Officer, Chief Braunstein, Rick who President; results

time, this call HeartBeam's Chief I Officer, over to the will Executive At Vajdic. Branislav turn

Branislav Vajdic

giving and personal important the Thank how lastly, start that I'd today. overview is different common than by to more really there out are is technologies brief marketplace It and powerful HeartBeam you, the like to VECG technology. technology most a of ECG our operator. in understand our

home. is actually There technologies diagnostic commonly the of and it be used and test can that for is ECG most at are and XX-Lead a A consumers hospitals one in ECG standard performed clinics. many patients by

or ECGs, instead, detected X-lead, complex attack it couple see for a for not but detecting are of examples not on they can is a XX-Lead There or You is arrhythmias, slide. X-lead. this X-lead arrhythmias. many adequate This heart sufficient are

is patient medical outside cardiac The the heart that full identify clinicians know is It aim including XX-lead the easy to or technology AIMIGo and conditions, it facility. is the quickly it there and of range HeartBeam our system of key handheld actively has In an the easy-to-use We been ECG. [indiscernible] for to and wires is electrodes device. to a help of contrast, [indiscernible] apply. size attack

activity and complete offers with proprietary AIMIGo evaluation provide symptoms The heart believe view projections, XD technology device it more Our Y, X, patients. smartphone VECG coupled for XX-Lead heart to Z, physicians, can conditions, higher monitoring enables and standard many heart a cardiac of the by reduce app in time remote attack a and a diagnostic than X capturing resolution, by of a software cloud-based could intervention cardiac the critical for ECG. we which

reduce The time medical hours to of shortening waits average the save many care, lives. seeking door institution X complications before will X patient symptoms and to that from

than more tool In An pain, chest of emergency addition, the not patient XX% the a attack. having hands [indiscernible] system. the to reduce and the health visits room of patients costs the room are care who in unnecessary of heart with would reduce to go number emergency effective

patient a So frequent physician. use has the patients ECG and with can a XX-lead feeling life time is get agnostic reading why in transformational. over take do to readings Whenever real having symptoms, think will that we a huge first, is be for XX-Lead patients an ability variety reviewed potentially easy [indiscernible]. situation by Well, of that to they

to the discuss help And symptomatic physicians asymptomatic is will will finally, insight combining XX-Lead over a gain potential [indiscernible] simply detail, to to care. and trending both XX-Lead with algorithms large an in trending number not time as [indiscernible] of to has deep [indiscernible] [indiscernible] algorithm. today. learning more we Secondly, ECG, predictive create allow unparallel longitudinal cardiac a ECGs guide feasible

coronary There artery the disease are a patients, about million market, billion total there We but patients, $X Afib Xx market. active have atrial which representing the billion market, opportunity In is larger. is X million a are to $XX disease address fibrillation only States, market. coronary United not approximately approximately which XX also

the U.S. to overall like the opportunity $XX only billion. turn now to the I'd in Rob about over Eno, call is So our President.

Robert Eno

Branislav. related AIMIGo. an We wanted on update to Thanks, our to progress give

clearance major will To AIMIGo VECG efforts. milestone a to for system for company, patient the and many so held for cornerstone the FDA basis expect it's FDA. be we of our important the HeartBeam, the for this the Also, the start, submissions initial cleared be be first for will reasons. to device further this XD Our clearance by it's be

platform The algorithms. AI XD excellent VECG approach for is an

major have progress run, on the in data the applying In and longer a data, for meetings weekly presented sets we result algorithms more especially and the in with patients scientific taking results the predictive believe underway. that or of readings could about AI VECG encouraged capabilities. unsurpassed frequently We QX. AI longitudinal at monthly, rich We're even initial effort we diagnostic top

X year, demonstrates there that decades as significantly accuracy addition, in clinical than dimensions, than AIMIGo information available more In occlusions a coronary and detecting our even last XX-lead heart similar ECG. significant VECG adding a diagnostic a standard JAK a crucial And study that the By single capturing XX-lead. part XX-lead over is better published in of the of showed summarized system in was comparison, resulted had our that a several VECG research there's a vectors is of in reading landmark diagnostic approach. ECG value here August the in which baseline technology advances in diagnostic for ability

cardiac University Castillo regulatory including President give Drug and Vice reviewer, she update with and efforts. that, lead has to holds is Debbie regulatory and to in like held Food on the roles, industry at and Hopkins branch. introduce a HeartBeam's PhD engineering an biomedical in Regulatory. reviewer senior also experience acting Chief devices Debbie She Johns our scientific of of various And where lead I'd Administration, affairs U.S. from the extensive in

Unknown Executive

Thank you, Rob.

wireless size from the portal y, signals VECG projections clinician that we have application our communication x, our a filed card system device and and system. As also a cardiac review elements. includes under review. among FDA displays credit for activity VECG for AIMIGo reminder, the XX-K application z with application, a a The XD includes records This XD patient the physician

As Rob HeartBeam XXX(k) of of and requests XXXX. active this for mentioned, the phase initial future remains FDA filing the in will with we submitted quarter have the FDA. and is The regulatory the review basis as the be passed received of and acceptance with Cornerstone application efforts. second completed substantive review permission have from We the questions successfully this

gaining progress approach, feedback we the navigate on to our and protocols. official communication of available continue advantage to FDA, our we regulatory testing opportunities clearance, have taken with all towards work valuable and interactively response including proposed tools As

agreed-upon review conducted official address of FDA open to responses. our FDA's and questions are in complete the the have testing these the process will XXX(k). of the We Once submitted, are preparing our

anticipating end currently quarter XXXX. X of are clearance We of by

I also want touch to second on our submission. FDA

second VECG Following, obtain we XD working a of course, AIMIGo be of will clearance. system, clearance to XXX(k) the

The symptomatic AIMIGo second focused XX-lead from both on to signals, ability physician ECGs, the the the device. are be XD of by of offer VECG synthesized baseline XXX(k) will which the and the HeartBeam recorded a pair XYZ

ECG for This for XX-lead personalized wave system a approach recently patents leverages form. issued synthesizing

key synthesized valid study output XX-lead XX-lead simultaneously FDA which and part application pivotal our AIMIGo XXX(k) X XXXX. The will named a of from a ECG. to submission ECG quarter between be submitted demonstrate study, recorded will by is A second to of standard the be the planned the similarities

of pre-submission details have held now have meetings the will To XX-lead been goals date, proposed the the Rob study. FDA submission. we focused study. synthesis on with the discuss of These this our clinical X on primarily meetings performance pivotal pivotal

Robert Eno

clinical Thanks, the and study, Debbie. feedback our VALID our FDA designed study. ECG Based on experts, we've from clinical

announced comparing those designed first FDA-cleared a validate both its and we results qualitative synthesis with patients we've of assessment last standard which the study, hospital-based by As to XX-lead ECG methodologies. the AIMIGo enrolled software ECG week, XX-lead the using in quantitative is

an in and the XX-lead a outpatient each enroll to suggestive simultaneously waveforms The to with up checkup plan arrhythmia synthesized assessing to or U.S. clinic expected recorded is standard ECG of arrhythmia. AIMIGo's the cardiac ECG demonstrate subject primary cardiology is diagnosed XX-lead center presenting X amplitudes. and of objective between ECG similarities The approximately symptoms sites study patients intervals routine of include or by to XXX for We arrhythmia previously to in

this completion submission of anticipate study, mirrors completed results, the we study. XX-patient the pilot an study. study, in XXXX. on of ECG by pivotal which Based pilot ECG preparation XXX(k) We these XXXX VALID enrollment second pivotal study and for we QX In application VALID QX initiated the in the

the launch AIMIGo of to occur by of our will We XXXX. anticipate end limited continue that

an Now back it I'd to update on AI to like Branislav turn efforts. for our

Branislav Vajdic

Thanks, Rob.

last artificial underway. we have As quarter, program discussed active an intelligence we

at positions deep AI expertise and includes Google. [indiscernible]. leadership including team Our has AI X Apple, Microsoft The experience,

sources, a various XX-lead have our acquired approximately development element X We fast-paced efforts. ECGs from million key in

to focused detect developed on learning initial deep have various aryphias. ability cardiac We algorithms the

classification value enhance simplify to including cardiac and further providing process. the this cardiac has in [indiscernible] had combined with XD May. number automated will potential VECG HeartBeam ways, side, our experience additional technology, of patients deep of AIMIGo card data, believe in presentation algorithms The including physicians AI for to HeartBeam's learning We conditions, and provide that the arrhythmias. a accepted user onboarding credit were

unparalleled repeated data learning patients from the And diagnostic and predictive especially finally, result data that in capability. recording the our we the in algorithms device, bridge run, top AIMIGo on [indiscernible] applying deep obtain an that longer believe could from you of VECG taking with sets

Turning to [indiscernible].

We patents, received portfolio. U.S. additional have enhancing our strong IP X recently already

the is our As system. current focus have AIMIGo on side you credit heard,

VECG easy signals. by easy followed With synthesize form the ability to create these ECG a carry small, second clearance to ability in to a will XX-lead a on signal factor. This be for a the use, to XD

In factors IP. addition, by covered there X additional our are

usual XX-lead. First, monitors on-demand holders opportunity [indiscernible] much offer to as take would model further signal, we extended to MCAT or current as obtain This the have [indiscernible] and an extended basis actually in a the [indiscernible], the well. such XX-lead operate an similarly X-lead extended

on today. the place. using that's is will I mean top will the the enable AIMIGo the that a patch something possible any technology, not readings, patient XX-lead which place kind device, of fingers really a X But in back of

system a combines continuous monitor. Secondly, integrated AIMIGo our with

allows ECG an continuous patents is of to currently for have our actually FDA is a that variable on-demand our We clearance watch combination IP with watch prescription [indiscernible] ECG. wearable first monitoring [indiscernible] XX-lead a of which the cardiac provides that XX-lead And functionality monitoring. finally, multiple continuous

ECG. a products, collaborating fields. watch simply and watch pursue XX-lead Our activating ECG these the a place XX-lead leaders including cover the the the remove variable of can possibility of development all ECG in on detects the chest, so to it that in patients watch abnormalities patents that with plan the options We and when

Rick to CFO, like our I'd [indiscernible] Brounstein. over now to turn the call

Rick Brounstein

Branislav. you, Thank

our $X.X in regulatory will now financial release and quarter our administrative market financials. XXXX give after our results. close wire the expenses of for Turning A press filings the to available XXXX million. crossed the review were the and brief both breakdown full just and fourth General I a that of of today. is

For XX, million the G&A year ended increased period same $X.X December million $X.X million XXXX. to in compared the to of $X.X expense XXXX,

expense noncash $X.X was related resulting since from awards options primarily to associated is stock-based increase The financings. primarily That following compensation XXXX additional XX, XXXX, with the amounting stock issuance the granted May to December million. employee of

process And Our commercial in the currently XXXX, in in compared our we we we commercial fiscal not XXXX, emphasizing HeartBeam early clearance change XXXX. team. in focus through in near-term actually our activities proceed had cash due spending FDA as is invested Of AIMIGo. fiscal down to XXXX are for the note to

compared for $X.X for XXXX. Research expenses and of $X the quarter quarter million of to development fourth XXXX were fourth million the

completion research are For in to the year the million million $X.X increase stock-based increase FDA count in as million clearance AIMIGo. increased development XXXX, XXXX the ended year in expenses, also supporting well by primarily development and $X.X of in December offset compared services expense due XX, the platform the to as for and to professional of head process, prior initial $X.X compensation which noncash the

X%, we a $XX,XXX X treasuries interest XXXX the Our months. short-term to rates cash is to are with invested in in earned of compared fiscal With 'XX $XXX,XXX conservatively interest up in duration equivalents in fiscal around income market cash XXXX. and in

these balance As a with higher our coupled million result $XX.X of following of rates. increased interest financing the in cash May XXXX,

for as loss for was ended with million $X.X XX, to $XX.X December loss and ahead XXXX in plan full of net December the full of We the $XX compared XXXX, as XX, a year of Net million year of XXXX. million equivalents XXXX cash cash million XXXX. to of $XX.X compared of

we anticipated XXXX. $XX.X cash As AIMIGo to to anticipate end last is XXXX, launch gross mentioned, financing of by in closed This into May, early of common the we while stock proceeds limited begin with of million. the

get that quarter used We the sufficient worth it's that Net capital emphasizing remain I HeartBeam in now million. deliver And AIMIGo. They activities stock to warrants funds and approximately was did on the move have result $X.X XX fourth operating common to approximately confident straightforward of in phase commercialization finally, million our prepared as May of XXXX balance very cash we milestones into structure our financings. on sheet shares before, a only not XXXX with this and outstanding. financings include were a simple any as said

Branislav to the for I'm turn to now his closing back going comments. call over

Branislav Vajdic

Thanks, Rick.

foundational the help XD company's device our this for conclusion, HeartBeam It also and for in will IP FDA to in is an by many clear a to of AIMIGo serve patient as year time future I We're reiterate cleared will and clearance the protected for So VECG the is be pivotal it developments. system company. be that our a exciting XXXX will evolution. be foundation robust the FDA. first want --

As we made completed [indiscernible] review AIMIGo the significant acceptance noted, and having successfully the progress passed initial clearance of on have filings the have phase. the

are available complete Once taken formal interactively work and we these their to submitted, the to regulatory have opportunities finalizing raised are of intensely review. the questions FDA, responses and our advantage by FDA. We will and the with responses our all FDA testing tools and

number We by of clearance for this QX the is of initial foundational reasons. year. currently anticipate end clearance a of This

the of in and algorithm a study be in have study it, we have discussed, patient generate will completed it or First, basis will second the pilot our engaged synthesized we as as submission we XX-lead that the we And ECG. pivotal we will XX have that's speak. progress completed actually once

the for XD are artificial VECG deep we algorithms signals learning intelligence using Second, developing inputs. our

this forward we initial We meetings QX progress look and in by and on much year. are presenting to the encouraged data very of early scientific the clinical results, at AI

will as initial Finally, foundation as and both we and patients [indiscernible] the expand to the we XX-lead synthesis, upon XX-lead to friendly as our a advance pipeline factors continue includes will advances algorithms patch on-demand, with clearance the as AIMIGo build such indications HeartBeam product that efforts, watch. the robust AI-enabled well AI XX-lead

that of funds end currently as to near updates questions. attending. early of providing remain XXXX this ahead to our would ended to of million and cash answer year. look HeartBeam we We of for our provides in like with to all AIMIGo your with it strong that We further plan as last the now $XX.X shareholders deliver is I anticipated you to position We December occur confident cash cash sufficient limited year. team on in our runway anticipate equivalents have the XXXX. And thank of by forward Operator? I term. launch

Operator

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

Benjamin Haynor

add with they you're surprises First straightforward? I characterize Are front? me, off would fairly the FDA your of gotten? questions official on, sort -- that for on was I that Any responses how the you've you showstoppers? that Debbie, Any curious on formulating guess,

Branislav Vajdic

Yes, on please you Debbie, that? would comment

Unknown Executive

Yes, certainly.

of be many So a received first, this of to this questions so participants. from seems -- much number

this FDA So is what submission within I process of of a from provides my both reviews experience open sides be status the assessment prior being is the for share their submission. current questions and to that our final and that Definitely XXX(k) and perspective can fence, expectations. on XXX(k) from process answered must typical where is their

process this me, agency. a sort the from and is questions standard So of for pretty

can, we the leveraged available have mentioned, to in to address we're engage using and, our all with open allow order and to responses that final responses will expectations will this of the meet agency So these approach align to course, submission. of our regulatory with the best where as in we've to as industry opportunities as tools we This us ensure doing then to make FDA questions. our that, help assessment FDA

Benjamin Haynor

to then And when -- have FDA submissions sort for those going future AI the expect is point? this submissions applications, of helpful. you might -- on the time that start of in? That's on open-ended Okay. at kind we do line on Or any

Branislav Vajdic

Yes.

AI, the know, technology in have development you we long. full for As engaged not development, AI so speed

made at we have really And We progress be. months. point, last schedule X what are, the assessing over incredible will this the

this ready at are are, not clear. point, that of effort we So submitted to but share to eventually phase we anything, in the estimating intensely the get XXX(k)

Benjamin Haynor

you ramp or folks adding of -- team be that later of commercialization then clearance, second And to potentially commercialization Okay. kind to on AIMIGo would Or submissions. of once me, on again? make some up wrap for that lastly is after the begin the up, kind kind Got it. that and of excuse these get the AI time me you

Branislav Vajdic

Rob?

Robert Eno

doing -- of that. take by Yes. I'll said, we we're XXXX. as a planning launch end No, we Yes, limited on the

some So current we're testing plan have in strategy to to team that the closer And device. get of plans. opportunity the and year. launch the up be with our as clearance kind experience with get conjunction our and limited commercial the work the with towards currently beta pretty end deep first defining with We the the ramping of team go-to-market we in of

Operator

the [Operator to now hand webcast. for there questions the the over Therefore, Instructions] Q&A for Brooks session. are currently any call I'll And telephone Hamilton questions no on

Unknown Executive

you, Thank operator.

relates more or First asks, follow-up question valid the endpoints? ECG patient detail, you specifically describe could study it as to in

Branislav Vajdic

Rob?

Robert Eno

Sure.

to by XX-lead ECG is we're of similar, recordings that reiterate XX-lead the XX-lead both that is clinically and So first, our demonstrate AIMIGo the doing to and study comparable simultaneous hospital-based a device. to taking ECG the goal synthesized of the standard

also the XX-lead, device has from the patient the AIMIGo we on. a So they're literally electrodes simultaneous place while standard

looking measurements endpoints. series standard XX-lead we'll closely other of two. a define intervals XX-lead. the what that There's FDA also are that analyze categorize they to with words, physicians and is. see the need to manner, called and will between similar blinded and the at in In which these amplitudes. in endpoint the synthesized and is ECG primary defined performance the a endpoint XX-lead be As differences all a the as measures the between also We've we've secondary The far arrhythmias similarities the criteria worked endpoints, how

follow-up far as patient the no there's follow-up, study. As in

mentioned to So U.S. think volume, volume. leading centers, They're during and recorded add on because ECGs the I where every lots sites. And to what single we research clinics, simultaneous analyzing up visit. also arrhythmia we're high I'd are enrolling only day. X a coming but XXX is, in that just patients they're And we're and patients these of high

to quickly a arrhythmias, We why and this and of patients anticipate expect expect completed able we in being range in QX see to to us which enrollment the enroll helps study year. be of also that's

Unknown Executive

Excellent.

already Next license? developed question. so them of you're academia. developing It seems tools by but are AI Why internally, like many not

Branislav Vajdic

we Yes, is published, relationship following of these are and relevant. a it keenly being that's there and the days, everything that's lot in

us, They're for data so the with key for want, input, And device, signals. are patient. device, AI ECG so much Y signals always it's and resource our single AIMIGo to luckily us, and signals, the very and XD that's X, develop differentiation. our data a tools of and or course, AI you this based that's the of methods if set on Z that However, we key control

we of even those in advantage why have why come So what's more device. like following all and field, situation to is we -- a AIMIGo that that's that signals out key rich the are of we set full sets data that of the of that's our but take in happening unique signals, all,

hospital important we in of AI, available cardiac environment differential shed comprehend many This technology not and be believe, patients patient. XX/X. on patient taken the is ECG will the by can data source based And users extremely Secondly, that will many, with be time. [indiscernible] and longitudinal light an of normally the over on the that that that's the this signals additional condition fact

that see we you And seconds lastly, And right? XX for results XX these have given are tools second published recordings, recording. all

on the make XX-second positive well. will accuracy having So a impact as recording

but all, of unique a of have our So what all a set that that else is are in in beyond situation summary, go following has. set we features signals, we everybody

the in if we many some internally, not main so So and one why algorithms of are that's plan they institutions some these have academic surprised developing reason hand, future the on I we actually actually of be of which, many, we other for wouldn't the to perhaps signals. engage them engage the because predictive more

of of areas the be of prediction, some else. everybody in well secondly, might they And ahead

Unknown Executive

you. the where next be will question manufactured? Thank AIMIGo The is, device

Robert Eno

helping been the Silicon Triple Valley with group manufacturing. -- So development called and a Evolve the been of who's in us hardware working with we've they link Ring, in with

forward when the so. , do a those are XX-K. month Evolve an can off are of discussed All we'll volumes, quality manufacturing, And [indiscernible] into But easy the to will be initial we in or likely systems the the initial get we moving we make in site. looking transition. higher -- probably XX,XXX we Ultimately, will

So time. get I some think going it will period for us of

Unknown Executive

Great.

deal with are that hear much FDA SEC the I that. are next to and very on able focused Our you cybersecurity aspects the question, as

Branislav Vajdic

Debbie, please.

Unknown Executive

that. I can Sure. take

the with So certainly, that start field, conjunction we FDA also confident in is information. expectations for from working all to To clearly for additional we cybersecurity regulatory that included that FCC side. feel our HeartBeam out cybersecurity the the systems area XX-K both is FDA, meet secure. cybersecurity our experts for disclosed also in I'll as able teams important policy internal we've point in our we with in and are keep end, but to the which -- an

Unknown Attendee

cost of of account medical very cost Did speak you to your study? the for your question, the financial fully Can studies study valid ECG Next usually are you within the projections? expensive.

Branislav Vajdic

actually is Yes. There required. believe. There's might people no is requirement. as intervention follow-up so no expensive not It

the you with In our clinical We've the and can go predicting events, So $X.X signed quantified CRO a we're of very X the first to end research actually XXX to the enrolling and the expensive. patients, subsequent of about sites. XXX, it organization it. cost be is the is that much contracts is commitment financials the footnotes the if and to see expected XXX,XXX. the less million approximately about going you we And the in

So the is to cost about the full going be of study $XXX,XXX..

Unknown Executive

no questions at more are this There time.

call turn to to for like now I'd Vajdic over So back closing the his remarks. Dr.

Branislav Vajdic

Yes. unable who earnings joining you for Thank firm, and were to of for conference today. and look questions, our our you each you our any thank you, will out Group, happy today forward operator. continuing your participation much to like progress would of to reach MZ to please more If update answer than be ongoing growth. we I to IR thank to assist. very Again, on your

Operator

And may for this today's Thank conference, your at concludes and time. lines your this participation. you you disconnect

HeartBeam (BEAT) 20 Mar 242023 Q4 Earnings call transcript