PLSE - Earnings call transcript Q1 2024

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Operator

Greetings, and welcome to the Pulse Biosciences First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Trip Taylor. Please go ahead.

Philip Taylor

Thank you, operator.

X, would your inform reflect opinion questions as today, I and that management's statements, begin, will information. of to and plans, responses during May other including we predictions, like statements expectations you to comments views include estimates, Before forward-looking only and and similar XXXX, today's call

more our uncertainties. or result of a release results differ These and today our Actual risks as and may in Exchange materially U.S. filings implied from fully uncertainties earlier issued with are risks press Securities those and described Commission. expressed in certain and the

any can Our to these revise statements. not filings the place update SEC's our Investors forward-looking be SEC disclaim website to or forward-looking on obligation found on on undue or cautioned are reliance website. We statements.

that measures. in discuss for in Executive will financial can section the including reconciliations also President We GAAP would press the non-GAAP call Chief website to the like be be release. conference measures, page. Danahy. Relations certain measures, Kevin to regarding non-GAAP comparable note call most will News at this that, now With with available over found these pulsebiosciences.com Disclosures audio financial our Investor Events turn on and and the our Officer, replay on I Please

Kevin Danahy

and session. of first over a provide Trip. Technology Uecker, will ago. Thank the weeks Finance, join Strategy to as in everyone, condensed today's for Robert President was remarks X results. excited Executive and review Officer Vice Good Mitch Chairman I'm Then update question-and-answer just Officer, afternoon, Chief last Chief our for joining prepared will me financial you, thank you Mike us. Darrin XXXX all Levinson, join me of to the and our Koffler, call Director; quarter Board; Duggan,

active CellFX and QX and X During today's very proprietary about Pulse for Biosciences. was end-effector novel productive proprietary devices. give delivery engineered we you will and update energy a nsPFA designed an our call, quarter system

of by Field pleased the bring we times and X beings As pulse millionths addressing pulse is in pulsed Nanosecond the increase electrophysiology in tissue Pulsed and range that you existence soft than to out of improvements making potentially deployed significant know, second outcomes. with believed well modality nanosecond, is and to a to Pulse treatment the billionths human conjunction orders up into surgical of speed a improvements currently This bring material magnitude overall field of to up in novel Ablation, ablation a as in material Biosciences a for the in faster capacity and area. us treatment This pulse in field are significant to treatment focuses in need. duration safety to second commitment ablation the is amplitude increase range. as thus, efficacy

Additionally, a option. provider-friendly nsPFA is very treatment patient, care physician,

we to single do has trials forward, skin not dermatological that planning inclusive note X,XXX indications. treated, serious lesions human are It across occurred. is Going to different a event important adverse of multiple clinical

our for XXX(k) system CellFX we noncardiac soft In March ablation percutaneous clearance tissue XXXX, received FDA with indication. nsPFA

is ablation Soft including a and of the areas breast wide used tissue by thyroid, body. the of range liver, in procedures, other physicians

tissue successfully performed Tufano, in Care soft System, in Director, collaboration with ablation Division the in leader ablation and Memorial of Surgery XX Head at thyroid, Currently, Dr. percutaneous patients need Sarasota with Surgery for system on CellFX have procedures Medical the for patients opinion Ospedale key in Italy, we Endocrine soft nsPFA Health Ralph Italy. Stefano Endocrine Napoli of in of Naples, Spiezia, have treated tissue field Mare disease. XX Chief our thyroid Dr. del

have weeks, observed amended days. as XX, for first XX, in last judged late January and or first were observed, Per treated All surrounding No early request, tissue XXXX. XXX point, X as patients Patient weekly be patient protocols thyroid. the XXXX injury the and patients are procedures we as procedure. as patient to this X treated of was The up at in week April XXX to to then has points and follow-ups the evidence been scarring XX, following have and XXX-day the been successful. time our

with for The the cardiac prior to to of has on In rendering our FDA requested FDA communicated nsPFA with in clinical we XXX(k) final regarding of for FDA updates the Clamp past our clamp. request Moving our the clearance. pursuit have cardiac starting indications, procedures. our weeks, few CellFX data a decision surgical Surgical

preclinical as treated Clamp. No As been animal only of has performed. of our yet CellFX with been work today, Surgical patient has nsPFA

to provide Ethics In response start the nsPFA application submitted in however, to is present to The Clamp. several This CellFX next device. would study patients we an Netherlands treat We up with centers our information the designed first-in-human the with safety effectiveness their first-in-human several Committee on within Netherlands. weeks. and feasibility study have Surgical study to the in the XX anticipate time, in

XXX° our for second CellFX indication Our cardiac Cardiac device Catheter. nsPFA is

for Neuzil, to Homolce Prague, XX and treated of and Hospital Reddy, Dr. York, Cardiology by Mount at patients XX are patients of end We procedure The in for treated the within at Vivek days Chief expected Hospital the are that safety. days. time XX study to Prague add announce the next Prague. Director New up of are to The Arrhythmia X Sinai Cardiac team of in pleased successfully XX acute his at this point primary and Dr. have Services been remaining Petr be effectiveness

to strong in ongoing the timely Biosciences upcoming Pulse Society, a we Discussions a XXth manner. with in the XXth Rhythm presence in and HRS meeting, the Heart have May will are at will updates present time, Boston. provide FDA

presentation live system in total as Our CellFX presentation. energy well as poster delivery nsPFA a abstracts will featured a of case X be

offering. our capital stockholders This over for avenue Pulse our offer existing entrance, the continue while to advance rights towards to company's growth. market end-effectors our the will the opportunity offering provide potential efforts serves non-dilutive now stockholder-friendly support Biosciences to to secure I a the to details as novel sheet necessary turning call balance a Before our to through additional strengthen Mike, on

The a the $XX will a to determined as filings the approved available that in XX have date mid-June. of holders stock the initiate offering changed be in our May, that will worth in been likely record not rights The all announced record date be date. to completed. date be Board up selected will July, offering necessary June company's or early Board all the common record of May to once specified so by most to million week, the and company of of of has of of Directors rights the This units

subscription immediately offering, company expiration date will to in been which June. also have most may It of be by no filings they commences the are company Subscriptions begin the offering, once the date once important if will that the the is completed. to note expire and rights value have not rights announced exercised the necessary likely prior the

that all offering. related exercise Assuming at $XX the gross And price, will million. is a rights to million, rights less raise subscribed receive of up company upon initial to potential the to the warrants, expenses the proceeds offering fully the $XXX up to

of would to offering quarter rights offering fully XXXX. release growth first Please on into A information. our the rights fund for plans refer the subscribed the company's more

financial over update on Mike results. an the Koffler call Now I to pass our will for

Michael Koffler

costs was you, and GAAP year today's of period. $X.X financial primarily million you to of the reconciliation $XX.X a quarter million prior first measures which compared to an I the compared Kevin. driven GAAP earnings and The Today, noncash in expenses first increased $X most comparable the compensation for in to in quarter our cost stock-based Thank XXXX million increase to non-GAAP and of total GAAP XXXX, release highlight by increase expense, GAAP in year results. detailed will $X.X the non-GAAP period. encourage million in I In the review prior to measures. million expenses by $X.X was

of $XX.X first Total million advancement expenses $X.X GAAP in to driven period. $X.X million was prior prior increase December non-GAAP million in quarter expenses compared first XXXX loss to Non-GAAP of and the the in an of the XXXX and research XXXX. was period. compared $XX.X $X.X as nsPFA devices. increase the million compared to of primarily in our to year expenses $X.X million million period. net quarter million XXXX by XX, and The year by quarter support prior totaled compared net to total March cost million XX, in $XX.X the non-GAAP Cash loss CellFX as million equivalents year in the of development costs and XXXX, $X.X in increased the in to $X.X was cash of first

XXXX. the in million was million over $X.X million in first $X quarter the million same the of sequential in $X.X by the payouts. back period annual now $X.X Kevin. prior mainly the quarter totaled in bonus used quarterly used The year increase Cash fourth of call I XXXX compared will turn to used in cash to and XXXX driven

Kevin Danahy

we as the Mike. earnings hands real-time of advance you, our patients. the unfold. provide on Thank continue year Biosciences technology as calls, is updates we for Pulse for platform future they exciting and into will physicians It to novel more In an benefit more events interactions of

open Strategy Chief Executive Operator, and Board, the Officer, the are Darrin me Chief and Duggan; Officer for the Joining question-and-answer for Levinson. Director, Technology questions. of call Robert today please session Chairman Uecker; Mitch

Philip Taylor

Thank you, Kevin.

a address received few up over we'll the questions e-mail. to questions open from we're we've Now line audience. the going Then for

interest the in commercial the now that launch? the What's the first can a percutaneous how level? it's anticipate launch full pilot is one we approved? And when is, electrode going with The U.S.

Mitchell E. Levinson

our tissue institutions were Yes. we've that to want clearance has for just take Trip, can been program, a we ago, reached high. this got that for our pilot to we We've a one. evaluate and few is our ablation. system really KOLs got targeting the Mitch. lot physicians out major at interest soft Since I of XXX(k) the that weeks

hospitals, We've process. As that bringing institutions got multiple an takes there's some several you process. approve know, through to technologies. KOLs may new longer, in sometimes usually like currently It approval and in weeks, this of approval working

system prominent We be and hospitals number clinics of year. expect our of going this to is used a by in end CellFX the percutaneous

our possible can we are we that just clinical now, and doing best the we help clinical customers Right providing building to technology. can get the that strong on the ensuring system, with appropriate support, just training they are outcomes our really everything physician focused around

Philip Taylor

you line now? Operator, please the open for questions can Great.

Operator

Petrone Mizuho Group. Instructions] from first Your comes [Operator with question Anthony

Anthony Petrone

FDA on a moving Congratulations just little I Maybe dialogue. direction. right pathway bit given on just progress the the like that's bit here, of sort little going a sounds guidance of They've clinical of It think, here. the kind on the forward. in

early views could on you there broad-based I sites? I pivotal And a be have many timing add And how follow-up. your when on so How How maybe could patients? one And anything like? program launched? of guess, many could this look

Kevin Danahy

want you do Darrin, to take that?

Darrin Uecker

sure. Anthony. clamp, is the I This on right? Yes, Thanks, apologize.

Anthony Petrone

would the that cardiac Yes, on right, Yes. clamp. be

Darrin Uecker

Yes.

an we we information our forward. very and the led one couple as had call, collaborative, think to additional last discussed this I So we as with recently, FDA. of on letter That we're great meetings FDA, moving with received a very from that FDA discussion

today, hold the goes on FDA After of need to had As human we as in request cycle, about AI review data. XXX(k) receiving clinical remain process. with for the we that dialogue And you I the mentioned, with probably the think know. regard as or we good letter,

the would really look of program coming and that FDA to path discussing like agreement on what we're likewise, some so the in that process going forward. and clinical with regulatory And

we to much Right terms that now, timing. in of don't on report really have

Netherlands things will on we've feasibility have we submitted that clamp, that discussed there. to and happen Ethics in first-in-human a our the which side of Committee Europe the study for the in clinical One the is

back and We expect thereafter. Committee to several that hear next from within study the then commence Ethics the soon weeks

that of the States. we've time period United side. be finalize FDA clamp be going that study, just of we'll the required aware over so got a and And on what's the in for next to on, working is with lot to FDA going

Anthony Petrone

That's follow-up would helpful. on a just And be HRS. then

being as States that's is post well. underway have the FARAPULSE ahead United there. live with CellFX now The presented you market out in here, the case officially Looking here PulseSelect and a presentations with

the feedback the PFA And from at So out of are Biosciences, guess, are physician you just by rate of surprised you of I adoption maybe Pulse the CellFX what expecting out catheters? And expectations on early HRS? for HRS? the of perspective

Kevin Danahy

Darrin. ahead, Go

Darrin Uecker

say Yes. we're -- Thanks, to Kevin. would would I HRS. I forward guess, I looking really

We you and actually have those both are and our X the mentioned, on abstract presentations, clamp. catheter as

we important the products for So Summit a meeting. have beginning And this you the that both is PFA at very to meeting. HRS then is as of something the encouraging mentioned, get of in live that our into case

PFA general, the I PFA, devices. progress those it progress by relates by seeing are that United not in surprised other the to as we're States of think we the And in and

and is advantages at think pretty nanosecond HRS over lesions and we pretty PFA to which What durability terms forward create that speed what lesions, PFA to excited lesions. to relates those the I we're current some significant depth it of the our seems is of the that is of looking it's PFA the and modalities. data it next view in integrity the as those of about generation able that about with a talking create, clear those the lesions, GPs offers are sort differentiation and

talk looking to forward clinical going about are different and supports be HRS those really think, our both present preclinical and important be -- we're our patients. that to physicians to benefits. to we able And both to that and data things, those all So

it's think course, we exciting and Biosciences. to really meeting in going also, for a Pulse nanosecond for but So general, PFA be PFA, of

Operator

question, Medical Next Production. Robert Lovgren with Hope

Robert Lovgren

surgical the is Basically, question Or ablation patents all this that all you, tip catheters and itself? though preliminary. Bob's head you're A a on the people other you real for spear? the coming. think of of of the This the Bob. plus, and have course, and the you The -- so machine is feel little

Robert Duggan

with is constantly similar, Well, base the we would and we're are you put want. bring law market. anything be which point, test to head really and asset a But what doing. you The Bob it a evaluate very At have patent when pleased generating. tip what you it not thoroughly, of this we somewhat we're together, It's develop to your right? against

I swing can copy, market, novo. find you to You really that's -- we confident you yes, our Bob. hope like we question, the Bob will speed de out. in, the I'm patent your and evolve can patents where bring so can I'm am But alter, which But Duggan. it and in I you go I a good base. at answers we're that position there, to continue that when

Operator

I Kevin turn to the to Danahy closing would over remarks. like for floor

Kevin Danahy

I support that for want and in operator. confidence to you to us you, Thank closing, In have thank continuing giving our all we just company. the

for that committed to for We to dedicated the with we today, ahead. Thank Thank delivering joining we nsPFA, and us company. are value to lie growth and success opportunities this and look remain you forward you. driving

Operator

This concludes teleconference. today's

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

Pulse Biosciences (PLSE) 7 May 242024 Q1 Earnings call transcript