BEAT - Earnings call transcript Q2 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to the HeartBeam Second Quarter 2022 Financial Results Conference Call. At this time, all participants will be in a listen-only mode. A question-and-answer session will follow the formal presentation.

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.

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

ourselves reliance in statements not present in any reflect statements, future our of are revision mind factors our forward-looking only of affect information that undue opinions this discussion, of to obligating these the results predictions. forward-looking we You are date place to presentation. relating on may publicly cautioned of the or light these events. we as release new to revise will some to which or today's our Throughout that attempt Please not business to keep important

XX-K A review XX-Q section wires crossed detailing factors is Relations and the heartbeam.com. of also our Form Eastern Time Investor more discussion the Form our available under press at this Factors. particularly and in afternoon recent most heading of the and complete website, should Risk company's release other these X:XX a P.M. for results You these risks,

Vajdic. Officer, Officer; Chief Rick host Chief over HeartBeam At XXXX. are will Hunt, the and Brounstein, I operations turn Business Branislav the results present Chief Your call Founder; to ended today Chief Jon Officer Executive June XXth, of Vajdic, Branislav Executive Financial for will quarter and second this Officer, time,

Branislav Vajdic

afternoon, everyone. XXXX and pleased good quarter financial to you, Thank call. second welcome conference operator, I'm to you results today's

the submission steady now -- of about pathway, quarter our the highlighted called FDA upcoming commercialization August or product by second XXth. along emerging [ph] on was Our AIMI to increment our including

unstable the platform, to injury product, AIMIGo of database [ph] for -- -- clinical to evaluating the the of a with patients of product, for submission now validation software to Difficulty] findings, the -- the product brought -- to In subtle significant we -- have we and unstable condition. changes analysis from access this make have inflation these tissue. [Technical may FDA Patients patient continue second for our cardiac once QX of electrical the expanded for in category patient discovered HeartBeam number We the -- AIMI [indiscernible] diagnosis called definitive year. our the population prepared company's registering provide for to telemedicine include wider clearance Based without a as on on technology FDA. by we

HeartBeam source on as to Jon. privileged and detection. platform, Officer We call to Heart live be Heart Health Technology were John, he products. powerful Care this -- of AIMI a code were where royalty-free We of us the key most together lead continue Development [ph] role a to the served selected our development development the of Technology Ken, our AIMIGo as and XXXX version for have the experience will honored attack Digital he Chief Company to John. recognizing license Jon Cardiac Officer and for the more Most branded products turn We plans, more this I over mute HelloPlus side, little Industries. -- our further has components Innovations discuss you to now be as recently, the to to the to platforms, enable Officer. platform Business approach annual Devices and Jon. may Cardiovascular to during would unique over of Chief like XX years' -- HeartBeam FDA quarter Hunt, recently founded the acquired Health winner commercialization of this overall our perpetual Ken Persen, with the internally. Strategy Technology in Chief welcome Digital Moreover,

Jon Hunt

Branislav. Thank you,

AIMI HeartBeam AIMIGo strategic and updates, product several lines to Turning partnership time we had developments our key platforms. HeartBeam our agreements and and to related

with As XXX(k) FDA limited release, receive of full imminent, clearance and AIMI expect XXXX to by We our Halo+ LIVMOR's FDA-cleared and develop market for HeartBeam patients. physicians version a Solutions to Digital the in FDA Health Branislav LIVMOR for mentioned, connect rollout HeartBeam to patient branded the is partnered of Company commercial and we a the submission turnkey QX remote to XXXX. platform of solution end of monitoring

for collaborations as position in the product with provides AIMI by of XXX(k) and the an algorithm acute submission emergency into our an health trial plans department clinical After HeartBeam have for as prescription-only us existing these the existing be XX-lead ECG AIMI of hardware software is will in internally. medical market pathway. quarter, Recently, additional the and leverages regulatory device is clearance the end-to-end product software continue clinical we attending used part workflow, the the or we be departments our setting, with our systems. HeartBeam ECG slots HeartBeam that version determining we the well help detection the developing to needs will portal, a schedule LIVMOR for for as a the Health the which diagnosis. ECG other subscription multiple patient's us and complete and heart for the needed acquired their patient. Revenue future of EDs, comparison high-volume AIMIGo FDA $X discharged they studies the patient be provided if this, branded System pilot this meet to During in data instant code average Systems, to Halo+ and via manage source allows Quickly the symptomatic attack Registered remote a we FDA patient's of consideration will helps, AIMI our solution days. model engaged partner FDA throughput. baseline and HeartBeam of at-risk can The for estimate per intervention, for patient about submission commercial HeartBeam patients, coming scientific and in emergency

these market $XX are total slide, the $XXX be for and estimates telehealth, addressable Software the to Next is ED billion about U.S. for million. the market estimate Solution please. Briefly, for And we at only.

have device HertBeam and plug platform remote the software the RPM company heart innovative attack history Triple of and AIMIGo development hardware co-development technologies. to platform, Engaging Ring development Triple and provide completed firmware partnership patient of of our closely FDA. the incorporates to monitoring. they is to and test engaged its scale. the a Ring We're ECG build device the Ring collection variety development AIMIGo a manufacture that complete This be now of with of XXX(k) in our design quarter designing Triple The remote in-time hardware joint efforts. expedited our for of manufacturer, development with XD, HeartBeam Ring Telehealth established efforts project, allows to an our for the XD solution, end-to-end ECG product, to and with HeartBeam underlying team monitoring submission device. solution vector is an ECG the to for company benefit able fourth a at Turning AIMIGo of product wide has OEM five long development XD our who device device Triple our to HeartBeam medical added assist design into relationship AIMIGo and rapidly HeartBeam Ring device successfully Triple patients XXXX for An scheduled the ECG working medical to Technologies, phase an and products in XD physicians. is the partnership we a

a manufacturing the indicate experienced for Rings a provides active partner management and to also develop customers, and regulatory their market to on the XD Data of the model per our partners data advanced market. existing Codes with builds discussions logistics at-risk HeartBeam And and the with a are Ring, can product practice discussions basis. Gen reimbursement patient, use pathway XXX(k) Cardiogram and identified cardiology X is of with AIMIGo to model allows HeartBeam handling support of FDA in is cardiac XXXX our with engaging like X care distribution capable currently release to a for features this commercial pathway. a with plan QX attractive CPT Gen Part for confident AIMIGo the companies where the submission. for already we'll per study. We've these subscription Triple a project In our OEM in the device a manufacturer shows AIMIGo clear have slide HeartBeam development simple monitoring us product. and use month level HeartBeam they monitor. validation practices, by for meet to addition, This product substantial device not timelines is so able is they enhanced business that product is of the an in of clinical demonstrate in Triple B practice patients team very several to collect QX, Vector XXXX. is The Clearance equivalents

and indicated symptomatic are the differentiate from capabilities products it by product each the the integration the the contain offers symptoms, as on card While information introduced comparative capability, detection. single for this AliveCor the only market. none Note, patient both HeartBeam device. them heart attack of recently slide, to its does heart ECGs, is not while on ECG KardiaMobile ECG detection, The lead presentation of AIMIGo, and Vector it shown baseline recording, of HeartBeam history of of other a attack some needed physician XX-lead recorded for

six of ECG we now the moat updates towards in our partners IP leveraging of distinct patent engage in Brounstein, applications beyond offers we over will HeartBeam technology US -- offerings turn I'll existing have Financial for our advance to and by of FDA continue AIMIGo competitive continue to near-term move to patents commercial patented XD provide that our customers we commercialization, advantage Officer, issued products. substantial protection three clearance discuss We to Chief Rick capabilities with fortified financials. a near potential AIMI and and and now anticipation operational and we substantial HeartBeam To-date, believe and Rick? call As portfolio launch a build of or products. approval. a Vector

Rick Brounstein

our size gross our percentage source of of our increase And results significant that expect sample model high case that compared department base it be And R&D. to Thank first HeartBeam investment modest capturing to market briefly in and XX%. become I'd margins revenue. finally, even we in opportunity total a solutions AIMIGo market to which XX% as for assumptions, highlight primary reoccurring operating solutions, company at under of gross addressable you, the market. also like margins margins generate even in would scale will is we above over Jon. Telehealth a time, like convergency excess AIMI the larger discuss the that much either of our base. the financial shows revenue with as can a I scales

to filings, regulatory cross sorry, our filings, financial us and full is breakdown after review regulated the market closed Turning wire financials. extinct today. release in our A a I'll in of that results. our give now press available

a now the to company XXXX in company first our working of private a two on public products. as results comparing are We commercialization

of very $XX,XXX million a and the much quarter second different were of for compared the exciting Research more in it's second to quarter So XXXX. expenses story. and $X.X development XXXX

focus of an HeartBeam HeartBeam to hardware, AIMIGo. Our R&D on agreement consisted both latter includes Triple product now to about, our services AIMI, which technologies essentially and costs is assist that AIMIGo. Ring done talked with professional in This and the with for software also largely Jon development hardware

there growth quarter public coming equivalents added $X.X have $XX,XXX the is as last to cash XX, of ECG the of the income three million compared months XXXX second for compared stock Additionally, $X.X support quarter and XXXX. of XXXX. costs product vector which cash XXXX second from both company. IPO. of the our quarter $XXX,XXX products costs our as administrative and Net to XD XX, the in the the In balances of in XXXX team of Interest we convertible with tied of to in quarter XXXX, compared the quarter to $X.X pipeline and costs notes, being of December XX, support from XXXX, as for and of $XX.X were second our converted the a a to was the of XXXX, million the ended were XXXX, and million for million second other during clinical We are June reflecting second well for at technology. net XXXX as $XXX,XXX patented December cash $XXX,XXX in to support this loss expenses ended expense FDA of related in of research loss General common IPO. our year platform submissions future for November's

for runway some call clearance turn provide in the will expect FDA Branislav, We the to that this and QX cash will year. position expected of our closing year over back into of HeartBeam well as now AIMIGo as XXXX thoughts. the next submission I the

Branislav Vajdic

Thank shareholders. value you, long-term well Rick. In summary, positioned to we our create are for

to – XXXX. equipped of near-term from a strategic During position cash the product strength, operate – continue development, partnerships, with second we quarter, into

upcoming team near-term would rehiring further the you all forward commercialization. as – And Ken our for of ahead, are to forward submitted I any position our a to By these new the answer Looking with updates a experienced support platform, for FDA milestones. we our shareholders receive AIMI to like by to to our XXXX, look attending. with We remain in the path and in questions, from HeartBeam strength clearance have HeartBeam our anticipated FDA I expect for confident commercialization Persen, CTO, clearance. now move of we providing product goals. our milestones the an team thank accelerating and plan HeartBeam our with the we to end AIMIGo approach solution we our of operator? partnerships

Operator

from Instructions] Please The ahead, from go question Company. Sutherland Benchmark [Operator Bill. And first comes Bill our

Bill Sutherland

Thank a Wanted you. studies the System. side have one to of at Putney things the afternoon, Health couple gentlemen. Good was ED ask pilot you Phoebe ongoing, about in

was ask I think of… the one that John question to

Branislav Vajdic

Jon. so Yes, ahead, Go

Jon Hunt

the clinical validation one our ECGs sites study for the some Putney was Phoebe of of provided the Yes. XXX(k). retrospective that for

the So obviously which people consolidated data the various for others some are that blinded doing the set from testing. has scenario, to in validation the used the set, training been centers,

completed. study HeartBeam clinical product. so And the for We've now that's that completed validation AIMI

FDA now ready So that's submission. being for just finalized the

Bill Sutherland

that to Go you Is pertain there the ongoing studies product? that now additional have

Jon Hunt

discussing XXX(k) some AIMIGo. process. that of but be towards the with we've of approached, haven't And but healthcare yet, now process those process those again, the our finalized the that in just systems that's We're for we in end conducted of will,

Bill Sutherland

their And LIVMOR. the the do Okay. Halo+ branded have to I your of on that's about the on for version nickel. branded the HeartBeam you kind question understand -- of development What nice providing how version a outlook ability for when one version? branded what's you

Branislav Vajdic

please go Jon, ahead. Hey,

Jon Hunt

Yes.

So engaged as for FDA wearable platform, Registered know, given an LIVMOR development they more originally, effort you had HeartBeam their is that do to already RPM the solution. but

is, perpetual And creating of for last were a that that's version label white royalty quarter we've in we've free. the non-exclusive acquired they done what So license actually HeartBeam. the

in So, royalty payments go-forward basis, but its that's because of on it for us to future development, a the more entirety relieves gives us, also appealing a go-forward basis. of us the control platform on

margin Rick So it side the indicated, that firmly and helps on control as well in puts the as us once our in. submission goes

us better perspective business as puts position it well as in financially. a a my standpoint from So from

Bill Sutherland

the good It the G&A the quarter. was outlook half thought what's of -- the I Rick, directionally, in R&D in for very year? back and cash management

Rick Brounstein

some I Ring are right? I rest do high mean, spending constant, pretty dollar-wise, to Triple we'll not the research, but I We've been think level. we -- that -- a be spending with throughout partly the at we year. continue of mean,

the of at go year, be the take you think the six we the look I if a different if through we're I'd very surprised wise, as rest first So spending year. of months

Bill Sutherland

no then product? guess you're sales I marketing and real the commercially until ready any really And ED with --

Branislav Vajdic

of to customers. but the -- people that that ultimately and salespeople some work IR, we Well, products. and that mean, will are it's at I mean, mix some is board now you with clearly, are started stuff. we've a money in got And Jon are obviously, trials of already. new PR do we we're on our we there has there's got -- early working on doing the -- company a see for first the looking team lead names maybe, that we some I We've

a have say I we are definitely to organization, complete way it. this guess, we So --

Bill Sutherland

Thanks. all are questions. Congrats progress. Those my Okay. on your

Branislav Vajdic

Thank you, Bill.

Operator

And next from comes question Please Kolbert from our Jason James. ahead, Jason. Dawson go

Jason Kolbert

anticipated up. guys. platform? submission QX the Thanks Can AIMI a for that's risk with Congratulations of talk bit a the lot. me in about associated lot coming what FDA the a Hi, points little you is clinical inflection with

Jon Hunt

And So XX-lead growth the sense, we that The a question in a we patient towards my study maybe that first-generating answer. might is AIMI let clinical product will me as that Branislav geared answer remote point. defined that basically -- of be a and ECG for for ECG their a recorded compare plastic the facility. and that's outside XX-lead we ECG physician synthesized XX-lead because record synthesized ECG, that of patient synthesized to the review XX-lead will to baseline

of So name. the the simple and nature XX-lead and between the their diagnostic so of content, in that study comparison be terms would the that's a recorded synthesize

is the in decided and we And and of content that not will that number we study. low the exactly a are I when outcome that healthcare the be performed, of of [ph] mission whole study think feel have of the looking into now. systems terms we fairly

And like add? to so Rick anything else if you'd

Jason Kolbert

really very Okay. Thank you -- much sorry.

Rick Brounstein

Yeah.

Yeah, were Jason. first, to trying the Sorry, you Jason? That solution software referring study you perspective, my think I or from to…

Jason Kolbert

trying to follow between and platform you've as events the… laid I was just the the the of math sequence

Rick Brounstein

Okay.

AIMI the the good AIMIGo. the just that study, device, the to completed algorithms substantial given point, Predicate are from about identical believe for the platform, is AIMI study The the from to that in demonstrate We themselves Branislav’s that. XXXK we've for good very demonstrate study thing that bar results to feel AIMIGo results we completed. and is the is So and is equivalents

a then that demonstrate generating to we emphasized XX-week that. pretty we So to cardiogram actual feel a But of in recording compared an vector got XX-week good hardware the reporting. want the XX-lead, given synthesized XD also about addition, device we've robustness and

addition in So already to with AIMI. done that's the work we've

validation clinical study like, with logical us XX-lead. Predicate if follow on, from already a we'll results ourselves the build stone, you comparing for stepping regulatory obviously, there's to the So and a gotten for we've AIMI

Jason Kolbert

don't or the leaders TCT AHA, anticipating enough point data really going opinion at where you was presented what compelling start present, and board of at other launches that year? is commercial the you to I and of year begin into on in key next I advance Where where to kind major this meetings know Right. get was, late

Rick Brounstein

their health who have a at post-market Well, the more companies number equivalence doing has participate been then value that might the and spend perhaps a having typically think were don't are study opinion experience My data. substantial leaders of systems KOLs so. They publishing already some at key believers we of I in already time in some care in big a of XXXK lot study, technology. see

Jason Kolbert

part Yes, the that is of plan?

Rick Brounstein

plan. my of part Absolutely

broader to clinical do help and study post-market KOLs go value us most I prospective I some setting. us regulatory occur a think, much what to in of but that to value through get which a us than remit our gives obviously, just study, recruit will rather is of work a it retrospective immense still is and a think done, hurdle, we've

Jason Kolbert

process. the I a you be And that FDA, going but a taken to can helping do interactions the a filings little want And you're that little area what just time time the bit it's that great. of you Because have emerging lot into seems because talk what actual aggressive, to with trouble. wondering de-risk a you've great so where line, just with I'm who's get gives that you companies And steps confidence about you you line. and to an meet to much themselves --

Branislav Vajdic

my FDA. health XX cardiac over Chief I Officer, and in has there X for a our the IDEs pretty have one also products Persen, digital involved are the that, with of is of our that CTO Alan Ken career. years. new Operating been number dealing I've industries and management within obviously experience management for IDEs several run rhythm think has Baumel, extensive run us in HeartBeam team, Class

already company the So with LiveMore with we have platform. consulting used experience was familiar that considerable very a

but their basically even that wheel, their we're through, it engaged helping we expertise worth we've in providing and reinventing was resulting. platform so piggybacked so obviously, lots LiveMore think input, So on we didn't get the though of --

Jon Hunt

you're third right. to outside to doing, allocate what It's always smart party an have

even to own want be kool-aid, track convinced your never though You impressive. that is drinking you're too record your

Jason Kolbert

my Perfect. much. so you Thank That finishes question.

Branislav Vajdic

thank Yes, you. welcome. You’re

Operator

no phone are at further time, this questions. there And

Branislav Vajdic

we have questions? any other Do

Operator

Larry, And now. you’re unmuted

Rick Brounstein

take will At this a point, of webcast questions. couple we

can some product provide The around color first remain. you ask, the

Branislav Vajdic

Yes.

of a than So our standpoint, marketing a decided with initiated we from request rather brands. a firm. we the we've some board, a house work company branded And house very be house experienced of prefer branding to and

those Procter and someone of house So is in Mercedes like & for world, someone BMW Benz you branded of like marketing Brands or is the House Gamble. a

that goes ended then So, you we software elected And with with potential and house. and went marketing device -- AVI product that patient We names. think, as yes, six the do five up our the and ended through everywhere. branded the obviously, to created we've as with, a conventions anywhere be I up normal Amigo, firms or a medical platform naming with

through. we process our beginning And the quite Board and month, So, actually, the that's we went they of this presented with to at pleased the that outcome. were

over process or four that run the five we've last So, months, so.

Rick Brounstein

And Ring? you the if an on can next update Triple asks question provide

Branislav Vajdic

Yes, me let talk yes. that to Yes, question.

So answer let action. me Triple provide an Ring on

has We been how this project pleased have with been very going. very,

We a absolutely this it beginning schedule, we with pleased. will here point intense reason for and we We feel team. capable believe all this that are -- Ring this are we’re work on FDA. the project delayed. Very to no have and on and we overall, ready believe is And, of interaction be submission, product team budget, on there aspects schedule our Triple very submission, at is extremely totally on

Rick Brounstein

on the XXth of the And on the are for next question track submission FDA month. if asked, you

Branislav Vajdic

Yes.

me that. Let details you give about some

have implementation as We is of Most ready. completed study. the today, the of

are of all this I. T be and dotting administrative the it's of point, matter a tasks that now sort accomplished. need the crossing to We At

pages all submission. about good being on up. lined a things the XXth it's the And administrative as have the just them this or and confident of will submitting final to are the matter of are prior we all we -- be So again, that in of on the of basically review

here. close So much we very are line the to submission very and

Rick Brounstein

around the appointment provide Persen? of some color The next can question is, you Ken

Branislav Vajdic

of our in we today, were Persen our amount and to the a to expertise with And to LIVMOR markets we he an meet and quarter which an improve and that to we platform We platform. is ultimate Ken going in -- that just we of of us be licensed for. outstanding needed. provide need extremely [ph] Yes. the company the license had brings company. change He to his capabilities our inside incredible pleased and sense, although attract perpetual the need He we technical able match forward. that need will architect experience overall with We now the and are familiarity have is And experience the terms to his capabilities needs. indeed, the technologies will

So very, us. has a that he very XXX% match and joined pleased we’re

Rick Brounstein

different And ECG you asks, in our and are last is Apple KardiaMobile? Watch question the that how

Branislav Vajdic

Let step. of John John, terms me competitive to that that talk ask in please. about

Jon Hunt

Branislav. Yes. you, Thank

Okay.

So Apple Watch photoplethysmography. is based on

cardiac a reads actually activity, It's also waves and And on an but calculate lead. credit from a it card on uses KardiaMobile that pulse and electrodes finger So ECG. single generates a ECG. actually single-lead

space. we Our cardiac record lead activity. clinicians three is XD XY vector of that The to organ three-dimensional cardiologists and from generate a conducts that vector can, ECG planes, is our is synthesized XX-lead, the three-dimensional space, different in in a evaluate in heart we three that standard recording, fundamentally which And the care use than Z. and

single they're to just used has cardiogram vector more XD than and a in of it we reading in it XX-lead content information that a that recording to the lead format can more informative fundamentally output in information the because clinician synthesized is provide. infinitely a So

recording KardiaMobile for example. So in nature, XX-lead, the Watch specifically to are, they to ischemic by it's card difference difficult our lead for and events events, a a detect neither Apple because fundamental designed is for very a look device spot and or single versus ischemic

Rick Brounstein

That concludes webcast questions. our

Operator

I Mr. would closing call remarks. now the back over to to like turn Vajdic for

Branislav Vajdic

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

Group, would IR happy of our you please assist. unable were to MZ firm, to If be reach who questions than answer your more out today, to any

in A.G.P. H.C. XX conferences, by At more Cap also forward -- like personal The X good we Conference, Dawson September wish at day. September this Finally, seeing Thank XX including ThinkEquity you. Global followed thank on the upcoming point, James some Wainwright time you I'd and of and Annual and October XX. look Conference, to to the you you to Conference. Investment October sorry, Small Conference MedTech XXth XX a one our Virtual

Operator

conference. you This attending. today's now Thank concludes for

HeartBeam (BEAT) 12 Aug 222022 Q2 Earnings call transcript