BEAT - Earnings call 3 2023

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Operator

Greetings, and welcome to the HeartBeam Third Quarter 2020 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 the statements made on the call and webcast may include predictions, estimates and other information that may 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.

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

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

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

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

and of to Your will Executive time, Financial Branislav Vajdic. host Executive At for in the operations Officer call today, over HeartBeam Chief Brownstein, President; present Rick Officer, Vajdic, results Eno, third will turn this and Please XXXX. sir. Chief quarter the I go ended ahead, Branislav Chief Rob Officer, Founder;

Branislav Vajdic

you, Call. our welcome third peer-reviewed Results about very business, you updates Financial I'm a quarter including a we XXXX and to Conference pleased to important good study team. Thank today's be relating publication today's call, our will some enhanced afternoon, landmark and significant products, On everyone. operator, hardball

continue make upcoming We steady clinical towards and progress to regulatory milestones.

technology. I'd like to our of a brief and give you HeartBeam overview

offered consumers reminder facility. for really the are you how who of It's you is a VECG understand of of many just personal joined the in as for ECG from those are those patients our most a that time to the outside are technologies There For today. with to first already the that common who and important different us. ECG marketplace in familiar technology and more powerful medical technologies

sufficient no, is instead detecting see -- are are This arhythmias I'm indicated complex sorry, all to a sorry. Well, or we complex not -- but adequate there can adopt home slide. adequate are to hard X-lead for technologies couple is are detect there that on for many no, and are ECG believe of what the while or to only is this detect that consumer I'd but for examples that to its couple use an say patients not are ECG of today do arhythmias. for These there use, easy these that are a Basically, out them. ECG You the X-lead. many like there not to

problem of device, a heart We evaluation medical believe and quickly system our the portable diagnostic of technology identify and a our of facilitate technology is detection at institution. help solve The outside key and system with has attack. remote ECG. to by a aim XX-Lead physicians. heart to app the the symptoms coupled potential AIMIGo accurately personal clinicians The software generate HeartBeam easy-to-use cloud-based AIMIGo smartphone cardiac is

In the the electrical addition, development set a for by for intervention to and attack lives. hours patient care, save X X with time critical rates heart algorithms patient the AIMIGo provide the data action to the complications of rich HeartBeam reduce seeking AI. AI use The of could for collecting to AIMIGo future that the these potential patients. of believe We has heart average and unparalleled data activity before signals

to reduce having In hands in the a to patients unnecessary number the more treat patient room emergency room thus reduce system. the care the attack. they the health emergency addition, and costs XX% go effective than of pain, visits chest of An we the of could hard not are

a total or patients U.S. approximately are coronary time, opportunity [ the the $XX $X representing our larger only. X market. approximately same for $XX AP is The These there the numbers the technology AP United million are At patients estimated billion ] billion market for in than a million is Xx representing States market. active artiopubulation disease market,

have opportunity patients the beyond that time. power have and will the of care. at arhythmia are conditions anywhere attacks. processing and beyond the [indiscernible] of AIMIGo their bring as standard XX-Lead signals, go the cardiography to using to technology XD Capable capabilities any to ECG These the to agnostic our ECG of from powerful the algorithm physicians We potential of vector-based ECG vector and standard recording heart care

our core industrial form deep variables presents us well alliances working including with technology, monitoring. credit that extraordinary we multiple been is believe, players factor, for key strategic an have AIMIGo, to with ambulatory on with with players, and protected our our product We a IP, card pipeline but opportunity, and

Our turn billion U.S. of is recently established to our bringing which our technology, includes granted wear on-demand travel products risk extended patents We $X.X by patch XX-lead technology were the which be patch. reach pipeline estimated this extended will segment. to on wear XXXX.

developed We our first arhythmia care continuous a cardiac VECG, integrated in the continuous combines motor. also patient into a cared pipeline wearable tenuous prescription extensive monitor XX-lead factor. single have IP through which of our The XX is cardiac our FDA-cleared which with a which cardiac monitoring Watch, acquisition system, form our ECG. monitor continuous Limor, the for Also combines on are

learning the you to deep Lastly, I our would President, updating turn to we Rob over updates. and to the forward on call are our applying efforts. look soon latest Rob? Eno provide business cardiac to to We these product like now in signals.

Robert Eno

thanks to Thank today. us joining and everyone Branislav, you,

and procedure were ability a use also during occlusions. PCI, demonstrated This that balloon This occlusions. interesting technology platform technology A based ] called standard landmark of design occlusions. study HeartBeam's simulate peer-reviewed of coronary a for inflation ability XX-Lead detect the American is to to Turning was the a recent Advances, in to VECG on stent presence published study VECG artery tested of journal of JACC [ or detect a very percutaneous technology ECG novel the a our both milestones. intervention, coronary Hartbeam's their coronary study coronary to College Cardiology.

study. takeaways There are three the main from

technology intended by institution. used ECG of in-hospital is performance the patients standard XX-Lead itself outside the a on of similar be left, HeartBeam's matched with health This a care to accuracy. First, technology in as important HeartBeam's is

the she event. study for pain, standard baseline was and area included, only showed and under was AUC, was better taken a the AUC of chest when performance accuracy when the ECG a was The the accompanied recordings. curve, Second, much by both than before greater XX technology the is or symptomatic X.X. for both reading ECG an by HeartBeam during one assessing when plus The XX when symptomatic a was other that XX-Lead around words, X.XX the measure payers including onboarded. And baseline just beams patient's because the than In patients ECG. is event, taken lower important he XX%. this is of plus includes baseline or design XX-Lead better increase taken always particularly accuracy when VECGs, more baseline ECGs heart much a technology or assessing by asymptomatic can

is that practice, an final technology could takeaway a have in the ECG improvement And taken in emergency HeartBeam in a dramatic over room. the XX-lead accuracy

heart in often always and assess the have beam asymptomatic we'll assessed ECG a room, will no readings. ECG emergency technology While a pairs is baseline. there's be patient When an patient's the of able to

room a plus reading could from more to increasing single So with emergency X.XX. X.XX XX be in the than a the XX XX-Lead accurate AUC XX% ECG recording HeartBeam almost

performance all holds whole. our on system will additional the the conducting that and studies XX-lead clinical and we'll when focused and be adoption. So to system believe patient be these study this AIMIGo on as demonstrates synthesis studies key We the of the potential a driving

Board our the positions to to Scientific. During Advisory Jaff Chief Michael and and new respected division leadership industry researcher, of Directors team, of is executives a appointment privileged the Nelson Jaff, quarter, at and strengthened Mark innovation and the and experience multiple Vice Peripheral additions Directors our of recent Ken Scientific Stroma. Medical to of a clinical and Boston We Officer the of and with Affairs; bringing add Dr. we President physician Board renowned the Clinical This of were technology board. industry Dr. wealth Interventions of vascular Board. follows

of XX advisory new And expertise research III; President, expensive Product. joined previously and joined technologies. and the She well to L. of his Michael the is industry for worldwide. physicians at to medical to health years Vice recently instrumental for the of electrophysiology, appointments has distinguished overseeing hires go as the leadership an market-level Medical Advisory release. we They President added Officer, welcomed experience extensive cardiology, as Vice Apple. Castillo brings This of our senior with Shenergy I device translating team, Debbie you with Board, Barma. oversee affairs get go-to-market in as also Clinical. Charles as announced brings positions they Heartbeam with sense leading are and we Niraj in function Fitzgerald, Health responsible of of interactions encourage Affairs; related She Rachel finally, will made agencies our board. Debbie five Harrington, and we'll Canada our deep over that key strategies Doss, well Abbott, regulatory years our St. is Her Jude system XX experienced clinical Brown, our regulatory Gujarati Chair members over Puja ranging We FDA, sensing EU bring. of recently company's as industry, three knowledge technologies Vice Rogers for insights most and see joined has press and Rachel expertise be the the experience studies experience Tony clinical market and FDA. Regulatory Senior needs The heartbeat efforts. of She in We Peter business biomedical engineer into experience the various Robert and our Chief President release read from experience for and to HeartBeamas ready new them clinical in group iRhythm of to a companies Scientific management and collecting scientific interventional Campbell wealth Gibson. the regulations.

toward product our We make milestones. continue steady key to progress

the we previously discussed, to FDA. have will XXX(k) submissions As two

application, which first, is is call our VECG submitted collection device. is clearance FDA and X-lead the the hardware progressing from The was May of have Version VECG AIMIGo in is questions This This well. FDA which submission responses. the a clearance We've to we submitted for device. HeartBeam received for X

application, Officer, clearance focused which for the software, review. generate On with meeting demonstrate including submission we Financial after we will of and presubmission the during the X X, the of call updates the encouraged call expect performance physician relation the meeting is study discuss successful the for Brownstein, of on second we've we XXXX. to our our version the for to VECG this ECG in continue design FDA algorithms release to receive ready the half held FDA, We're will product over and the ECG. by financials. second XX-Lead synthesized turn interactions Rick I'll clinical version a limited a Chief standard to a XX-Lead this and The be for that for operational synthesized that XX-Lead with planned market now

Richard Brounstein

you, Thank Rob.

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

looking expense of noncash options million, employee marketing and not overall is to focus in change and commercial is we're increased compensation actually XXXX $X.X emphasizing following in by from in financings. about were team early activities. offset cash the the our XXXX. G&A May invested at near-term primarily we in to In currently the 'XX, Although XXXX, spending stock issuance XXXX expense was sales the stock-based compared flat, due resulting down commercial of Reduced

third development the XXXX. $X.X of Research of the as the approximately compared of quarter quarter level XXXX and same for to expenses million, third expense or

also costs development on product from technology, research is both to support future the portfolio in patents. our of we the addition XX in In of the arginine, issued which patent platform patented focus pipeline basis periods, for coming current in invested our

$XX,XXX of year. of quarter of quarter for short-term the XXXX was compared net cash last X%, $XXX,XXX Net around the current last we compared year. cash million equivalents the We quarter to of the in to the market income third loss earned to third of million third and quarter $X.X loss as in interest quarter in the interest with $X.X ended in XXXX million XX $X.X in rates $XX.X the third compared of With third XXXX a of December million for ahead plan is XXXX.

receive We in sufficient second our with FDA in As clearance expect early the HeartBeam the XXXX. milestones confident commercial to stock cash in we important XXXX, AIMIGo. mentioned is the $XX.X May, last we to to million. to and AIMIGo on which of closed common product prepared that is these of version planned commercialization gross we financings for while move of get to into X, deliver The proceeds funds have remain phase in half HeartBeam

of importance result, million they They include financings. straightforward structure that with sheet the fact and is and the stock a as has our Also capital financings approximately a any only now. in May were 'XX balance simple XX warrants did very common shares outstanding not

over proposals Finally, I share turn XXXX shares X plan. meeting which shareholders at included annual closing equity would of event, back I'll recent incentive like adding passed, also Branislav to million results call all the to our to of for thoughts. authorized the the the now

Branislav Vajdic

Rick. you, Thank

future optimistic for incredibly Let me just remain say that the we HeartBeam.

momentum, in financial the towards categories. continued company like would and efforts following to milestones key I recent and validation summarize progress the Now sales.

several validation and momentum of company. external continued technology had the of we demonstrated that the announcements First,

published General wear and patch, patent on several trademark additions landmark clinical overall. We American Scientific to our the granted Advisory management XXth College key extended patent And our Cardiology senior Our patent third Board. office study Directors, was in our team valid Advances. the Board of U.S. of made our

Next, has as summarized. Rob

importantly, FDA toward progress on travel presubmission steady made device. our on synthesizes initial our hardware. application have which AIMIGo will application, from Amigo algorithm productive We with we our discussions on meeting with the be Equally the key our the power ECG with successful a that second had milestones FDA

in a of for second XXXX limited half launch the is unchanged. expectation remains Our

significant cash XXXX. short-term of investments a have also well very early strong the position ahead position. the of this cash importantly $XX.X equivalents cash And providing We with We $XX.X million quarter plan. million to cash ended runway the and includes in

we reiterating forward to the interactions on now questions. And have our like in providing track past answer our remain like the with look shareholders thank milestones. FDA to I to term. HeartBeam updates positive and all close that would attending. you by the would key we Operator? in near the product for further with quarter, I I for your team

Operator

Ladies this Instructions]. conducting answer session. time, question [Operator and we be and a at gentlemen, will

Benjamin Haynor from Alliance is question first Our of Global Markets.

Benjamin Haynor

congrats me, on progress. the First off for all

Just a I that I presume knowing in on with it's any the curious productive dialogue, interactions submission. The there. but Is just fair it FDA. questions on things you've the showstoppers look like that a the aren't been that mean the questions. assumption? answered first like sounds there

Branislav Vajdic

or be Yes. number FDA which tool with We have don't as our consideration basically that's into meeting concern pre-submission have up details, definitely turn on FDA on the going anything a serious had our submission, that we FDA. as a subject horizon the our really brought of on first issues future well interactions stopper. the Without of definitely short now but with under that would submission, we as our the you tackled was

question of are negative no that that, of it's about in all, goal. able of not our a but in achieve work, judgment, to -- nature in points our would no be terms bit all So being quite there

Benjamin Haynor

takeaways Is on pre-submeeting Is something it Okay. of positive. I and helpful Is thousands? us can sort is the give do you humans? like? you is study mean, Great. bread animals? rails can of there any -- share I you Is look mean, That's And on might definitely in kind hundreds? a just what that dozen? sounds it it can it on it the is bigger in that then it What's guide box? a the than that potentially design? any

Branislav Vajdic

endpoints. subjects. the the be appears high. expected, FDA our And with to in proposing be of going and fairly that what cost FDA, the nature it's the And study of far how now we Indeed, as to humans course, studies, the study was of in what going as, and significant number a basically on be the for meeting clinical we and is in will pre-sub Yes. and terms is terms of in be the topic simple a in are range positive it designed that to all executed. not It's of

So all so have everything the on in as is looking all, far. envisioned study, we

Benjamin Haynor

Okay.

editorial as earlier, back like cash it But other that any any positive that So on according was I'll that and with it intrigued was is that utilization. put there folks came the plan you reaction or know just are me well by JACC And have you Can I in going from you queue share you've then the on jump published. side publication. findings? its gotten of sounds lastly for ahead just everything the kind then color folks and that away to are of from that? a deal big plan the

Branislav Vajdic

please answer? you would Rob,

Robert Eno

The good been Yes. Sure. positive. Yes. feedback No, question. has really

equivalent physicians both the how look though the standard think has potential study I spoke we're that lot was occlusion people of theme the a were new of intrigued importance especially XX-lead, the I hospital. for a balloon I the problem. adds by and this the of I think show this to apples-to-apples think the to resonated baseline, even attack, when much a really insight, And were outside as at and then to is heart theme of way lot that a a to really think potential for assessing XX-lead which that I of highlighted, this accuracy, ours. the to as using a way kind And good interesting we a design inflation to

gets they getting feedback when that a not I advantage. accessible it's emergency our interesting has to who So readily together room because a tried accessible to baseline provides I as baseline that really two potential those being think, everybody put actually the to, you is allude the we're goes

see really and prove about a were the as to to we So step work more and data. to I study and think physicians great of it forward the us it continue the feasibility excited very talked provide with to looking

Operator

on no call have questions conference I moment. would further the like And [indiscernible] Instructions] We [Operator question. at to take the a

Unknown Executive

question ECG. a or will read with if they a cardiologist the get the webcast the will you latter, interpret how or have AI patient who XX-lead a first asks, heart ECG The home at if attack, the patient,

Robert Eno

by We the really Yes, ECG well. it's as I We important reader with giving thing. can it's the question, a a believe for quality if Yes, be consultation up sent use analyzes one physician. for and can take is crucial the sent it's great service a that which -- evaluated it's gets service, an the physician this That home that and to don't want the app. not will in the to the AIMIGo whether at the is it. beams and where initiate are patient, reply interpretation them and visitor will to algorithm And a needed. that to the Gap] of the telehealth especially case be the then synthesized. attack cloud up, then or signals you heart patient device set position is chefs perform idea then will -- device be the processed, in the then the saying reader is a to in and even heart [Audio the XX-lead

a loop we're are that potential incorporate workflow important, things it's especially and heart with the think we to there's that. So like the dealing when building physician in attacks

Unknown Executive

more on your the system. that Do learning Our have of next deep you effort? you details to question application asks, mentioned

Branislav Vajdic

it's the it comes terms relevant its of medical in in to society. is future impact it when And various always And really It's area. comes headlines areas the impact learning and of to on AI. deep -- our quite Yes. in general

the set we time longitudinal offer. importantly, of very will over traditional can all, and include beyond to that looking data collected believe, time over set, unique provide, area or value our set that patient And goes a for that specific with XX-Lead believe that that the set impact on data combined frequently going ECG, all we data ECG data technology will be advantages impactful. in AI So at it's have what

in in keenly are plans our making AI, we in interested in of and So and announcement the be efforts near this terms area future. some will we

Unknown Executive

do have asked, you for XXXX commercial launch? capital Our enough next question

Richard Brounstein

So Yes. for a sounds like that CFO. the good question

fully which So points the a round clearly have commercial couple to plan second enough product to is get That said, of clearance for and we of through fund the commercialization. the do that. Yes, we another it on ready launch. financing FDA money get to

round but several we months So have a out. expect bit carry for between commercialization another of when we we to when of really and little to both, get leeway probably ready would need

comfortable feeling . from position cash So we're very the today.

Unknown Executive

milestones? asks next what The term are near question your

Branislav Vajdic

We decision steps. regulatory two to approach submissions made our a in

synthesized one system, what hardware system, ability call our we that system, site is The to important hardware the credit first synthesize were to foundational very the VX lead it's cards well our expect the in that weeks. clear XX submission the be of to XXXX. indeed, right it is second And for be we these now, stands to both VX will cleared seeking

Unknown Executive

about asks, question can you development new next Our business talk opportunities.

Robert Eno

Sure. the I can new cover that touched Branislav that in technologies. overview his on of one.

And associated right FDA strong really So of progress focus, obviously, this commercializing our IP making and that we much we products as them. company's focus. that we time, the is with Getting our have is that. on That the that. rich good pipeline we're system. same very now At believe have on Amigo described, through

the which we also watch, XX-lead card the what heart monitor the plus watch. beam continuous call is the and ECG system, integrated watch So the

monitoring. think well themselves of ambulatory some the really size company, wearables our those, to area And of in partnerships strategic and we of given lend the especially

the going I another areas. -- coming some AIMIGo touched on go-to-market is pursuing So question we're I'll And on will we be discussions of maybe that companies future strategy had come -- in just the for system. with through, to seen for which months the those I

in are developing good detail. about go-to-market what product be the to in plans And in a so outline ourselves. progress we months, to going lot forward to more plans. bringing that We're coming making are market our them go those planning we'll more And unveiling

Unknown Executive

on go guidelines you to a CMS how emergency CMS And to the do therefore, is Our for becoming . pain plan chest department. patients question asks guideline? next current

Robert Eno

that as take Yes, I'll can I -- well. one

the And if you so chest reality go all, interesting to delay emergency first another guidelines the to the room, and have a one really that's accepted really of hours The X to think reimbursement down of are X be issues should well you today. guidelines. technology go that right as is We fundamental getting the the going. of path for question. goal ultimate unique before patients pain, is often exist as this the into

answer the be so will show with the the studies and us done that and clinical for all It's important cost And evidence. short that to is going and to data really be evidence effectiveness. effectiveness generate

ultimately. takes patients this that's it evidence device, so that get of the And ultimately work would help the time, . the into something this with like But kind guidelines. when to showing benefit use

Unknown Executive

you where the several There market? are And a X-lead? dozen question what last our asks, in finding . see another companies do the X-Lead this value And market. is of

Robert Eno

as I take well. one that Yes, can

you orthogonal X, good three so really you're gives points. getting X-lead then we synthesize the talk reduced are and -- full that, the data you the devices other projections in electrical And not leads, three from orthogonal device, Other it data vector heart. all using collecting specific the lease basis the aren't when X-lead can that that's they're Z. leads, some are the not devices, collecting set those our about XX-lead. all signal. of cardiography three And VCG. collection on these Y When is touching Now axes. That And

lead that X-lead difference our is we the are VECG. for So

device are believe to earlier, it's with those be the cleared they're But because all the that taking the the together as signals. -- then physicians XX-lead we who heart to leads the collecting allows the to getting mentioned used move as to collection important laid hardware XX-lead. stepwise we're that's seeing. We approach, to a able analyze that on synthesizing orthogonal X-lead So strategy, three it's a as and for involved, we've what out us baseline

three XX-lead is it's to stepping differentiator. get having leads which . So true our a synthesis, to stone the orthogonal the

Operator

Dr. we some the sir. have turn back you, I and reached question-and-answer end closing gentlemen, would the Thank of for remarks. the to like And Ladies call session. to Branislav

Branislav Vajdic

joining operator. to thank of call continuing you, to each and like you forward I conference Thank update progress earnings and look our would you ongoing on to our growth. for today,

If your reach able more than were day. please would to IR to Group, FMC questions who today, assist. not answer any to happy here of out you our Good be

Operator

Ladies and lines you gentlemen, sir. conference. at much, time. very your that may concludes today's joining, disconnect then for Thank you and you this Thank

HeartBeam (BEAT) 14 Nov 232023 Q3 Earnings call transcript