Earnings call transcript Q2 2023

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Operator

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

At this time, I'll turn the call over HeartBeam, Chief Executive Officer, Branislav Vajdic. Please go ahead, sir.

Branislav Vajdic

Thank you, operator and good afternoon, everyone. you second welcome results XXXX to call. conference pleased to quarter today's financial I'm we relating will updates call, today's On be business our about some and products. our important very

enable vector focus development, clinical to took ambulatory regulatory $XX.X of funding or million into Recently, cash extends the to adjust and products, our delivery execute this late our we product which opportunity XXXX. milestones completed With will enable VECG, upcoming timely on us future electrocardiogram, our in strategic runway drivers. value and our to we funding, key

Our application FDA will device. we first HeartBeam the synthesize to on FDA step ECG. This is for VECG and FDA to May be obtain system's ability following the a AIMIGo XX-Lead to in clearance a XXX-K this application with submitted was second the a

Given XX-Lead for our this facility. withdrew software devote energy ECG that resources and application for medical powered system, is and are in to AIMI a will into products of XX-Lead the our us ECG applied outside This the XXX-K of we a strategic patients product department. hands allow which of being on our the our to all AIMIGo focus to emergency

in first our VECG approach presence to demonstrating platform paper, to Advance's, study our Cardiology. XD We of of The JACC comparing appeared the Journal College publication of detect coronary of conventional our just announced XX-Lead of a study the ability the foundational peer-reviewed the VECG artery American ECG blockages. standard

bringing of board also respected Mark Jaff, of Nelson industry number X our executives, HeartBeam the Strome, Michael with X. Ken appointment to We Dr. and members strengthened board the

recently Ph.D. private experienced Vice years' the experience to Regulatory FDA the Debbie for President and Debbie our quality and an in and brings excited team assurance to both medical are XX welcomed sector. also is and diagnostics, than affairs regulatory report devices with and of Affairs. that, engineer more biomedical we We Castillo,

automated with property in system. intellectual believe VECG patent our space. HeartBeam ambulatory to detection cardiac U.S. with continued portfolio Finally, on effort we quarter, this our a new the AIMIGo in the leadership the by Office issued second solidify underscores the patent We Patent

As previously of to offering worked HeartBeam. and our registered a are total million, We reported, placement for closed be $XX as year, secondary Ventures a of of this Holdings. by of Xrd tremendous direct MDB $XX.X we They million, for followed Ventures May Capital MDB have $X.X with on of offering partners agent. proven wholly-owned subsidiary a Public Public strategic million.

with visionary their is Ventures have a community backing category. member-driven market that mission public become a of investor in Public companies to potential technology leaders

to execute that plan to are example we on the strategic our work believe our to with we And We moment global intellectual tangible in ongoing our we our space a we in PatentVest, example work the also an leader them build portfolio, PatentVest services. of fact, continue is how mobile VECG an with We their and MDB on our is commitment. of as entity, as plan. use with continue property

for VECG development our the technology creating clear of patent focused HeartBeam goal unified leadership expect technology law a in we state of PatentVest support and detection. like will firm creating and is area leadership they IP ambulatory developing on companies cardiac

strategic turn Eno, focus Rob I further Rob? to our and would to to President, updates. over provide like call product now the our discuss

Robert Eno

will interpret strategic the creation We monitor important and physicians cardiac are We've enable on focus this patients I value hands. of XX-Lead path. see bringing immediately remotely today. refined thanks joining to patients' but our concentrating the reiterate and Branislav an events last everyone performance mentioned a We ECG concerning which any into as to platform you, key us our and quarter AIMIGo to platform, Thank wanted points. this

detection be addition, which in most the we ambulatory clinical and is believe performance AIMIGo cardiac HeartBeam In available. the studies platform advanced to XXXX of beyond we'll platform the demonstrate undertaking

common XX-Lead publication mentioned, when is technology ECG. for in but the demonstrated is putting standard detect a study to capabilities baseline Branislav This published the of accuracy of XX-Lead the used As the are as cause the first peer-reviewed of comparison of integral for that It ECGs highlighted technology something to analysis. attacks, related is the was the technology a in ECG it's today, presence HeartBeam also advantages analyzed, baseline recording our the This coronary same the with Advances. not comparison. JACC a to that occlusion, heart a recently

and with of clinical save our medical this signal and a whole institution as adoption. system speed-up a potential in conducting performance patient the driving key record be which on focused believe detection, studies to system demonstrating on attack lives. synthesis studies The an these study and We'll be will a significance additional heart the of to improve outside care could to of patients is easy-to-use XX-Lead ECG to provide the we and access diagnostic-quality

AIMIGo to with synthesize finally, Our and business of I'll FDA AIMIGo we'll technologies as partnership the for XX-Lead our portfolio. potential second pre-commercial after the a commercial HeartBeam HeartBeam our will for mentioned, -- clearance other property of market partners ECG. obtain we're PatentVest. year, undertaking aggressive efforts, And defining describe in initial HeartBeam minute. AIMIGo this for and our this through aggressive just launch detail intellectual be continue the we Branislav in And version development more activities segments a identifying algorithms for that in

submissions. two our planned to XXX-K updates, we Turning product timelines have and FDA

X, device. collection first words, X-Lead we a clearance hardware. as other The the version ECG call obtaining is In which for

the builds and take version synthesize review. algorithms VECG that XX-Lead for X-Lead upon signals version physician the and Next, X X includes a ECG

to application means get scheduled. excellent scheduled version meeting FDA. the In key for once process feedback look pre-submission In May, in FDA has by a a cleared submitted We'll It has also we on we closely review. of June, a both That been physician The ECG submitted on to a we been started submission. is version on meeting and our XXX-K will X. pre-sub carried half for for second elements X process X. XX-Lead synthesize for We've request pre-sub to forward be focus release The an market patients which we these FDA, a XXXX. these can estimate working applications. by then submissions, result with that of the the limited device of of

Affairs, appointment knowledge of we've of President as of an With our with FDA. the biomedical strengthened extensive Castillo engineer Regulatory experienced Debbie's team. Debbie Vice the

and Debbie reviewer. branch scientific acting addition her at various experience, including chief, FDA, held roles In private to lead sector reviewer senior lead

to opportunity development, HeartBeam is product, focus AIMI. regulatory on market. AIMIGo our focused and ECG withdrew the the the XXX-K AIMIGo ambulatory an which clinical, HeartBeam market for in preparation will room to the application efforts for effort focus emergency we is AIMIGo. finally, This HeartBeam decision HeartBeam smaller than on on use product company significantly And HeartBeam AIMI allow

I'll operational now Officer, and to Rick financials. Financial discuss turn the call Bronstein, over updates to Chief

Richard Brounstein

Rob. you, Thank

to I'll brief our review now a give results. financials, our of Turning financial

close So crossed a press filings, full release regulatory XX-Q breakdown in after is wire the available in that and business today. of the filed we the our the just

last compared expenses administrative second were to the year. quarter quarter General the million, second for $X.X $X.X XXXX million for and of

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

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

R&D this quarter. compared differed Our focus XXXX on to in

organization, development our with focus largely LIVMOR submission. FDA was product of in the and both products, on costs, of outside our our our and consisted preparing for an working platform regulatory first While development for XXXX development

This R&D with XXXX. development in Xf use agreement wholly Triple services or We of continue clearance over from team, employees, represents Ring. June hired XX, HeartBeam in this we quarter, our focus time, at AIMIGo. professional the submitted on our quarter, investment FDA and and May ended our Triple Version LIVMOR XX% is to U.S. the same Ring our

a So in device program. we cost reduction investing are

we XX, of a have of basis both this platform product pipeline future also June from we for $X.X VECG invested technology the periods, remaining commitment XX XXXX, project million. in with coming in portfolio patented our of support them for patents. issued our In of As costs is patent which research

income around $XX,XXX we X quarter X%, rates With interest XXXX $XXX,XXX of in the we earned only in the of compared early second for and current May. second XXXX. financing in closed This the this months quarter short-term as in to the markets interest

million $XX.X compared in $X.X December of net second We quarter million of ended for as the quarter a loss XXXX. investments, million second $X.X million the cash XXXX for XX. loss short-term was of second quarter The of net XXXX compared and with to equivalents of to the cash, $X.X

mentioned, May, late we product. received proceeds into The when of to XXXX, our have use million. for of planned clearance As $XX.X the to approximately we with net stock in commercial common closed financings expect last proceeds is time to

we track. We on confident remain are

XX the recent financing with is our approximate XX, we result, such shares short-term fact straightforward XX.X sheet, government-backed short-term in to outstanding. to market offered June only our $X include a investments, very holding simple The X-month money that in as in term. we risk-adverse million structure. short-term and X to million Approximately balance any the Also a With represents is that a importance did a and warrants in of now maturity. investing take the regard securities funds are not investments approach, capital shares million XXXX has

event, the S-X authorized which shareholders. effect annual of passed the all incentive to X meeting million Finally, the overall shares XXXX of At the I'd dilute the recent to like equity share of proposals our plan, included adding reflecting financing. results

now his thoughts. back over to will turn to I closing call for Branislav it

Branislav Vajdic

following HeartBeam. and Thank and you, the optimistic the of for strategic like recent incredibly summarize financial, We the future validation. efforts in focus I remain Rick. would progress categories; to

runway cash we XXXX. Following capital our million to $XX.X raise, position, a late have strong providing

application strategic and adjusted delivery development, is have the on milestones. the a our for our of X breakthrough and FDA submitted executing to future In driver this Version highly June, Version request of AIMIGo enable products, on the focused on HeartBeam's a The regulatory and system. submitted element our system pre-sub product we credit device. value timely clinical key we of ambulatory we X key in We XXX(k) company's focus VECG have focus VECG card-sized May, of HeartBeam are

Castillo, We the new are President with addition Regulatory, as submissions. of the these we FDA Vice excited work our on Debbie about of

of milestones company. the add several and technology recent Finally, we have that the the to validation

to addition Debbie study members clinical joining an team to JACC: foundational had recently Board in with granted our Directors, automated was management Our Castillo strong we patent published detection AIMIGo three additional added on the HeartBeam in and our We cardiac of system. Advances.

our in like I for shareholders and HeartBeam all updates I forward team term. your answer providing questions. you the near thank look now Operator? further to would the attending with today to

Operator

question comes Ben Haynor from Global Partners. Alliance with Our first

Ben Haynor

on the progress. congrats And

just came but kind the study? any performance you've surprises, human out First off of solid was it's maybe any for or device And me, publication? to talk JACC then -- know wondering reaction with if the the and/or positive obviously days you regard gotten of to could that the reading negative the I early about,

Branislav Vajdic

indeed, event patient's fortunate partners standard caused the team And a those sign this have value all puts of the that that of of that well some editorial medical very as high-risk future have very a a power is ECG, business very of huge potential in noticed a as actually patient acceptance. were pocket. well-received for as study publication, we that's shows our we a our is well. It's for as a members with our always technology associated significant our patients. publication a This impactful. care, an Yes, The XX-lead that and

extremely So it's our all-in-all, publication, first the and is only first this well-received one.

we works treadmill technology. We showing of continue on have the follow-on the a efficacy that publications of our publications and will in of the few

Ben Haynor

current guess and works, have you I the then off, study in they can surprises published be or on any discuss, the different or the you And might similar you first just anything about, publications study? that there the maybe well, to how share can

Branislav Vajdic

like can the cannot of at coming And a Yes, that it to the these point, both IP wall, really studies our publication will out of the a on. this speak. at be front of HeartBeam take front. publications future a of patents different cadence that have bit I we And we that And and discuss angle again, but every are details continue many I number studies technology. you number on will working one and in the in so tell a brick will

Robert Eno

you of I'll don't less think agree Completely in add briefly, that. thing importance just any maybe if out don't maybe baseline. with Branislav, of I surprises, is but question and I mind. I which there's obvious, comes don't surprises the which the the is one a think all paper think

So in compare the better the what's that the VECG results to of part integral process. with and the an when about both were XX-lead, used that's reading. is was lot a interesting the baseline And our

without We enrolls in definition. and And analyzed think baseline how patient you today, isolation compare have baseline. often by analyzed are about a when the when that they're XX-leads we a

that at have a the baseline to So sometimes VECG We're performed XX-lead in is the a both equal going are one comparison XX-leads and always in the vacuum. top paper to or time. analyzed line a of that the

kind point in think but study. subtle the I So important that's a of

Branislav Vajdic

Rob. you, thank Yes,

Ben Haynor

guess like fair think And it about the $XXX,XXX of was was mainly or Rick, maybe kind forward what then non-recurring assessment, we Is couple, G&A, for kind should going quarter. that I a the line? G&A maybe on that on in a of there the sounded

Richard Brounstein

million, non-cash, I I but back But up so. yes, see, see growing expense I go $XXX,XXX, say, now you And would again that XX we as to you'll commercialization XXXX there late we for until or we've getting if okay. was of probably, reoccurring would SG&A start expense. non-recurring XXXX, right? a won't million stock non-cash indeed, say shares, to think, No, XX

Ben Haynor

Okay.

there any I to I financing. related said to wasn't thought stock-based you $XXX,XXX comp, have the So may it. misheard that related --

Richard Brounstein

No.

much As company. the options granted share a a result more to now we of the in financing, stock lower had people who

Ben Haynor

Okay.

So wasn't any the there -- expenses Xx-ish deal? of with and kind G&A associated

Richard Brounstein

didn't mean, ran the was to the just the associated through go is not all no. I equity, with quarter, anything No, in that P&L. financing stockholders'

Ben Haynor

more it. you got how's Ring, that Okay, then that Any on with for Triple cost it That's progressing? provide? can the And reduction me. program, there color

Richard Brounstein

Hey, that you handle to Branislav, want do or? one,

Branislav Vajdic

Go ahead, Rick.

Richard Brounstein

Yes.

Okay.

it's and start look mean, will we price. costs something at buy looking prototype-level to going a if at So, when most It's I there's card probably take year. PCB other the over be doing various Ben, pieces device We're now reduces a We're a some we'll volumes, $XXX, we things. get a be to molds able be produce, So, some the to approach forward right? on. going that to to that of We're that, things basically couple board. the it's looking dedicated of $X,XXX to that are ongoing. reasonable and credit to commercialization But that you would, in at

Operator

questions At will [Operator take now our Instructions] time, we from this webcast.

Unidentified Company Representative

you that Our first that tell about Can question more have mentioned you withdrawn asks, AIMI. decision? you me

Branislav Vajdic

Let that question. me handle

ambulatory on is focus strategic Our devices.

know, had You distribution Valuable different very and AIMI by application market a strategy.

to and need the runs the basically XX-Lead key and the is of for VECG converts much for more opportunity. the As VECG the we market. totally algorithm important the is bring VECG it advantage room huge availability, of to seen to Actually, AIMI as planned probably market institution. XXx is closer developed and VECG focus larger market great the that of patient be the with well. and future which The This AIMIGo that opportunity ambulatory and is it in the our XX-Lead we we take have the the opportunity get on a make market, to and to VECG or healthcare emergency AIMIGo than takes generations progress its that of outside as analysis to included device us

expect technology down AIMIGo to the we sense, in appear see line. that in this So

Unidentified Company Representative

you timings on webcast high-level final timeline. a the and question clearances of details submissions future only is, the Our are FDA rather providing than and second detailed

provide release You second say half you you're more market expecting of in context? the a limited XXXX. Can

Branislav Vajdic

Yes, ahead? Rob, go would please you

Robert Eno

it's a Sure. agencies. outside about large and Yes, to whole filings the thing extent, uncertain. control the dealing regulatory that's is regulatory And clear when timing's our with one of process the regulatory

we've this X X to release version the some second but which version So key the providing timing decided the our continue is ultimate also on in X updates focus continue we limited to rather after milestones, these today, on happens release the give the the both half version the is market which toward going XXXX. and AIMIGo market about of estimates of of and date we we'll steps, And we've that do of achieved. of our progress did keep we're than talking going intermediate that achieved clearance of things milestones that to forward focus milestone on progress on But update to products. on as upcoming that

Operator

I like for to turn closing comments. to floor back over Dr. the would his now Vajdic

Branislav Vajdic

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

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

Operator

conference. today's concludes This

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

HeartBeam (BEAT) 10 Aug 232023 Q2 Earnings call transcript