BEAT - Earnings call transcript Q3 2024

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Operator

Greetings, and welcome to the HeartBeam Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call 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.

of that release not revision the forward-looking in mind revise ourselves to in future statements publicly or or results light keep we obligating are to these events. Please information new of any Throughout important relating today's affect predictions. to some may factors that discussion, attempt business present will our we to our

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

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

Your host operations today, Officer, President Executive September the Rob Chief present Tim will ended Officer; for Branislav and Financial Eno, XXXX. Cruickshank, Vajdic, third Chief of results quarter Founder; XX,

I Chief turn to will Rob Eno. over call Executive Mr. time, HeartBeam the At Officer, this

Robert Eno

status an submission, which cover management of and walk financial We'll operator. slide. to top of the the provide listed you, topics before it our Thank everyone. quickly results The over you then our today's get on updates, company turning and company's call are overview on Q&A. FDA on providing upcoming a update mind then of vision milestones the brief through for and I'll we'll is into

they than highest wearables. This patient data approach, signals a We a developed core vector-based from ever wherever technology with patients users possible heart's electrical and greater do paradigm the HeartBeam a synthesizing first has care. device, XX-lead capturing dimensions resolution far this using existing that carried allows the then new a are. to capture X ECG. developed in that cardiac use can the enables by HeartBeam's in cable-free ECG XX-lead

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months, our past the into Over few go-to-market refining we've significant put strategy. further effort

on practices. Our direct initial patient is preventive concierge focused targeting pay, cardiology and plan

Beyond believe system this, hospitals and we'll be gather evidence benefits cases, our effectiveness integrated of cost will which use specific we payment for by the basis clinical networks. the and insurers, delivery in of

enable our and our are core There which the form fundamental of IP advances approach. X

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way. Two protected captures that capture resistive electrodes the axis, Z-axis finger capture and novel chest X we're the the is the invention electrodes body. into and dimensions through network dimension the to the a Next, capture able key X a novel vertical horizontal

application, These have patents XX enable with reading. ECG combine and and saved XX-lead issued the even of population-based. transformation to advances X we used a personalized This a ECG, create XD ECG. the ways And onboarded, finally, conversion, an established synthesize this are and to we patient's we When more take is creates this the a breakthrough single a matrix, transformation the forward. make In take vector patient XX-lead order accurate and worldwide. the they're personalized we XX-lead HeartBeam which There is going signals matrix. total but use fundamental

Now into update FDA submission. let's on get our our

XXX(k) the FDA. the the responded asked Since continues last our FDA review by update, to to we've by active through questions clarifications. Our submission and through progress are working

We is and with we work and them. responsive, confident FDA clearance. engaged to the to continue The FDA fully be continue interactively in

results we clearance, While predict to we submissions, our related the achieve we update soon will optimistic can't as as that FDA remain foundational time it's lines or will FDA we and market achieved.

cardiac over evolved organization forward huge for products. prepare we've ensure as breakthrough to is set a multiple at leveraging HeartBeam quarter, time. company look the on such for the managed. commercial My past we and XX how the team care has have a success. will go-to-market to is my strategies up years impact to focused leave I'm technology on honored career Over our The the commercialization. I past transformative pivotal for is creating truly management expertise

also I'm new with growing to businesses with wealth from partner our as and Cruickshank an to He know I brings thrilled benefit we'll Tim knowledge of that. CFO. incredible technologies, disruptive

with from to forward will experience our company working leverage to to the look AI prior his Google apply guide how technology. we and Myers, who I Lance core Additionally,

partnership our success been managed His Of got the play look Branislav, what I would care this possible course, in is forward this of who vision integral founder, how and will point, going is Vajdic. none and cardiac our drive Branislav an to role my without with have to forward. company change continued to

words. to over wants to add Branislav, to it a few Now pass I'd like who

Branislav Vajdic

is right we sales, of lead commercialization. always transition Rob. point with understanding and reach for the company of we I long-planned a Thanks, leader would This keen his marketing go-to-market started is the strategies. the to when strategic evolution be for Since Rob the Rob of he had part company, and person knew together, and great a the HeartBeam right and working have synergy, I

to the and our as vector-based with congratulating in working able given on and intelligence my continue ask the Lance him growth CEO. want he Please I give company. join artificial for advancing support you in as to be on to of thrilled role me working thank focus you capacity you CEO new driving Rob? of new same efforts I'm moving turn a on support his in and as forward research as development all drives that to applications. Rob technology, me our innovating with Rob I have the the

Robert Eno

Branislav. much, so Thanks

Let's our attention key to now updates. some turn

have We on HeartBeam's and technology. evidence growing clinical of a body significant

peer-reviewed We on and of and technology publications more of both technology as have ischemia. These potential have studies the well in care. in on include cardiac as that demonstrating X use technology's the studies arrhythmia presentations patients, the the collectively XXX the fundamentals enrolled advancing than

be which recorded standard be arrhythmias. package pilot for synthesized our submitted study we've our For Heart study is synthesis. FDA At part of XX-lead Conference The results a for from a as comparing the the ECG to XX-lead to U.S. both areas, ECGs. clearance Association the American this month, presented studied ECG detection ECG study, a precursor the our those pivotal for of of clinical XX-lead simultaneously to will will our XX-lead pilot signals similarity later

addition, the X AI of algorithm this arrhythmias. our in In studies were year presented classification earlier on

study in attacks. technology occlusions JACC month's AHA, was our year Advances. used in on our coronary in be novel with on ischemia, published data algorithm detecting ECG And a presented conjunction heart last For will at this

learn more than as clinical usability the have and studies, we about of recordings XXX people, the XX,XXX we these meaningful system. providing performance than Beyond for more insights

to our validation receive addition to In we from body our data, significant continue of peers. clinical

new and Rising best Health October, a was at Annual Sixth Foundation Diagnostic renowned Breakthrough HeartBeam Healthcare Award from ECG named chosen category. solution. of Conference the Global MedTech thousands in Star the for Awards after the Home Hub This received comes During in months Health companies Digital we technology

they care outcomes for of These to wherever dedicated get One main manner in a they occur capture high simple a or delays the prevent to timelier in risk cardiac when care in to challenges way the to care. team's minimize validation are need increased of patients helping signals fidelity work death. of is our any a symptoms an are deliver patients awards hard ECG worse

And I'll financials it that, to take the quarter. for through with over us the Tim to turn

Timothy Cruickshank

on financial really time remains the in The resourcefulness with been of resources cash here, focused with while HeartBeam on across burn. the in I short also functions. in minimizing discipline maximizing my the company impressed quality only but in and and I've delivering team, milestones, Rob. not September Thanks, team's began

just activities Net such million, G&A. loss The million. was is When operating cash $X.X weighted R&D in compensation and XX just $X.X XXXX adjusted XX share-based was items was quarter heavily the our third than which $X.XXX initiatives under as million. used for million, noncash September $X ending for and September at net the XXXX to timing cash differences, more the clinical balance

and also necessary the and with a beyond was was on In I help in my the the partner building Board provide strong on utilize initiative execute and with Rob its and board structure CFO past the twofold: to traditional the role coming resources the experience teams to be company, leading to company to given goals.

working refine groundbreaking to And team that like from as well key from the I've committed existing stakeholders as I'm all investors So the with to technology to strong last month shareholders support spent happy with we employees. further our the have say are engaging to strategy HeartBeam's.

milestones, commercialization. manage of we're our confident to we'll With our maintaining upcoming the focused HeartBeam, which adding on to on Rob the going milestones business, at the company to and you slide, through the advance strategically cash and you, opportunistically our of we'll place next capitalize the Back over we Rob. is walk to Here align dilution. to all pieces in achievement finance continue in to we're and investors key have burn value-add

Robert Eno

Thanks, Tim.

a coming achieving number We of which we creation the in milestones, important value anticipate months. have

First is clearance. our foundational FDA

FDA, and latest confident of that have receiving productive we've continue are As about to be discussions questions and have to with clarifications, the through working we continue responded mentioned, clearance. to we set

a previously, discussed of the this major foundational submissions. all is the for it's we future basis As as milestone clearance company

XXX(k) ECGs The centers. We've XXX-patient to of for our endpoints. Our submission. We to XXX-degree alongside planned our submitting the HeartBeam XX-lead X study in arrhythmia for is meetings our discuss second of and completed VALID-ECG a vector and XX-lead from study, the that conducted second ECG a at as we'll The signals. U.S. FDA submission with pre-submission FDA enrollment VALID-ECG the X submission synthesized this ECG detection. study VALID-ECG, simultaneously planned held synthesize algorithms recorded evaluated is study part standard the basis FDA be those results XX-lead

endpoints receive of to this expect FDA clearance, study will prescribing Upon results initial of clearance, occur commercial program a predict cardiologist pilot and earlier, the the the soon a clearance. it service. software, after presented We're the the XXX(k) for As XX-patient same the but AHA timing to estimating mentioned system next we're month. begin We an initial XXX(k) physicians be application reader provide second will prepared second an measuring can't XXX(k) anticipating the the at patients, to the submitting of with we on us XX-lead important clearance synthesis the start we Upon feedback early year. limited use launch. access by the we're

effort, on AI which focus arrhythmias. our of is classification the will Next initially

presented clinical to we As is the of beginning mentioned months, our on algorithm expect be coming indication several finally, to month, clinical we data other releases on complete, signal have in previously, to X demonstrate next the year. events. with studies submit to the we enrollment the sinus anticipate or We're the RAISE-ECG and clinical classification we've these data of in the ischemic this at arrhythmias. performance as expansion plan called AHA to rhythm of have results After presented to planning from FDA algorithm. the FDA. And the AI additional interactions clinical study we a the arrhythmia And

clearance, and engaged FDA cardiologist reader closing, foundational the of our FDA in with to to and continue the clearance. service. optimistic to Upon to prepared important in we on start So feedback provide XXX(k) use an prescribing will by we're physicians patients, we the the with productive early be program access discussions system initial achieve be continue us a

Over quarter, to management commercialization. the ourselves upcoming updated the we've position last the better team for

and of extremely clinical Chief effort evidence in on Association Conference addition, Myers field. continue Heart adding excited Lance be capabilities fast-moving upcoming presented. well a the we're to technical X technology leading position to continues American presence will our In at our to our supporting us grow, The week Officer where and studies have incredible AI next this to technology HeartBeam's as on lead Scientific data will body bringing Branislav's

our we commercialization value. delivering for and have clear evidence preparing strengthening focus a base, on we're While

our the position sight for of and regulatory put in shareholders and clinical line XXXX. focused the providing delivering on burn a the help forward have upcoming in financial minimizing will that near launch updates further discipline We cash remains company on company milestones milestones. to look term. to with commercial I while The

We Operator? up thank it now you all for like to attending. Q&A. open I'd to

Operator

have this phone questions [Operator at Instructions] time. no we It like looks

take now the will questions We web. from

Unknown Attendee

on of you the asks, what more Our And FDA the detail first webcast clearance? items? the provide can question outstanding are timing

Robert Eno

to that But confident I that, in reiterate then term. preparing preparation question. great beyond begin can initial program, we're that ability It's the not the will take the access I'll we the management appropriate we've It's engaged details evolved of the all just one. the present. we're FDA after near And discussions. discuss our clearance. at achieve and Yes, in commercialization, discussed, clearance FDA responsive, to a which for early currently as just very We've is and the provided we've team, FDA remaining for want to ongoing and this information in FDA

Unknown Attendee

raising burn, are given your asks, your for capital? plans question next Our cash webcast what

Robert Eno

to want take you one? that do Tim,

Timothy Cruickshank

cash thanks. just I XX. Rob, $X.X quarter's effective cash flow with And just really an this We're burn our believe, important million, job around closely. managing at Yes, operating headcount doing question.

what lot So going variable R&D related coming sight really line we've cost over achieving to got clinical keeping to be of to we're good a quarters. and milestones. where Rob next the milestone you the of through slide walked And

stated to which and maintaining focus believe on we've company our call, the on value investors, got we support groundbreaking here the allow opportunistically, the at And in committed from technology. shareholders dilution strong managing term. we us As short existing will finance while to is adding this

confident in upcoming strategic to in requirements the manner in alignment advance we've our a pieces place business in really So the cash with capitalize of commercialization. with milestones, we're got

Unknown Attendee

Branislav question provide for said, in more webcast a to That timing reason and providing asks, change on CEO, next on appointment and to can the congratulations context Our you from Rob? Branislav to succession Rob his the for the CEO thank plan. you to strong

Robert Eno

one. take Sure. I'll that

thank for you First, that.

company, Branislav Branislav think been is of for has even January joined from a to a and before As since and the the company have data, products, strong I and XXXX pipeline he's we where transition to as the long which mentioned, together where we close also are really clearance. consultant. I I served we a believe planned true worked but we the I the founding leader now, first closely have time. a and -- hands-on FDA clinical took visionary, very strong we're of when then, was

now, for this someone a by So being is the this having led background. and Branislav thought commercial at time stage the long with transition company right commercial by more of a

groundbreaking the fortunate upcoming been a pioneering to is prepared technologies number and the cataract has I our think stents drug-eluting developing from stage noninvasively flow. I've of from for And those that those one to blood I FFR-CT in of at measures me learned first have executing for well what strategies really that surgery worked to with lasers HeartBeam go-to-market introduction the market. into

is all involved with going efforts. technical company. emphasizing to going finish Branislav lead that He's So of I to stay just the to the I want guess I just -- by deeply

projects So and development AI R&D, advanced efforts. the our

going the I Branislav is his from company skills his going continue have that's partnership, and forward. to a go energy and close as benefit to So forward. definitely had we to and going continue

Unknown Attendee

Our of how VALID-ECG the next update results question the study? on you asks, timing provide can an and

Robert Eno

Happy well. take Sure. that to as one

XXX-patient the U.S. signals study we HeartBeam and And just XX-lead mentioned study, enrollment. we've this had standard we centers, simultaneously it recorded -- completed as at VALID-ECG a reminder, as before, is the ECGs. quick So X and

peer-reviewed, it of will submission. We that not this results the about can't Unfortunately, be and synthesis. yet basis the we upcoming on been submission the the and the FDA talk of it is data have analyzed have because the second basis XX-lead data,

the want to is results attention upcoming same going But measures presentation study I about the be did pilot Association. everyone's XX in data draw to to at VALID-ECG. Heart on as That the XX-patient the of American It's that endpoints the days.

Unknown Attendee

right goes revenues could if like question asks, HeartBeam? webcast And our for the last FDA, what everything look with XXXX

Robert Eno

one? don't why take Tim, you that Yes,

Timothy Cruickshank

But a Sure. for the can't exciting I front more to in this an future of say, now, quarters. This I'd question company is updating forward answer opportunity. significant working is wait we're of I XXXX. throughout massive. possible to revenue stated such And mean in I in lines wherever previous going the quarters, opportunity time think market detail we course, of be us and expectations anticipate bring the don't is in and in to on progress our course, XXXX.

milestones road of we laser-focused slide solid the real on. the where we're You map saw give that a

this we through the on of will, commercial That's to our HeartBeam think you access now beta, launch. And market the initial program. critical back time FDA I system if kind early upcoming our of clearance, it's the take

So getting it our in to on information, the gaining feedback critical pricing strategy, going that user coming quarters. for models, will when information our the go-to-market And comes. us the our that of that we're impact critical launch commercial all refining be give biggest

Unknown Attendee

concludes That questions. webcast our

Operator

I now turn Mr. closing remarks. for call Rob his like back would to Eno over the to

Robert Eno

ongoing any XXXX to would we who MZ we to I'd earnings operator. to exciting as of the reach a to close look We the achieve number It's like our of our ahead to for on happy today, you, today. very each and for progress of please to continuing year. update Group, more milestones to going an thank the months firm, out be assist. near you answer few growth to term. call your as were in joining forward look company Thank be If critical you IR conference out our questions than we unable

Operator

gentlemen, and concludes you participation. webcast. your conference call and for Ladies Thank today's this

You may now disconnect.

HeartBeam (BEAT) 7 Nov 242024 Q3 Earnings call transcript