Earnings call transcript Q2 2023

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Operator

Good afternoon, and welcome to Vicarious Surgical's, Second Quarter 2023 Earnings Conference Call. My name is Sara, and I’ll be your operator for today's call. At this time all participants are in a listen-only mode.

We will be facilitating a question-and-answer session towards the end of today's call.

As a reminder, this call is being recorded for replay purposes.

to Surgical call comments. for like Brosco to now Vicarious with a would turn over the Kaitlyn I few introductory

Kaitlyn Brosco

you, press Surgical you call. thank June website. XX, the Sara, participating copy ended available Thank today's of on A in company's the three all months Earlier is financial released for Vicarious XXXX. results release for today and the

the like Private safe harbor to provisions make Litigation results include begin, or of of I'd to in to events, that future of within the XXXX. statements contained Any relate forward-looking this this performance of we that call pursuant will Securities statements are Act remind statements. laws, predictions Before or management expectations Reform securities that during forward-looking call statements made which meaning federal you are the

All and material without forward-looking uncertainties actual current and any and for market expense forward-looking involve to cause Accordingly, these the timing could obtaining approval, to management, implied Surgical relating not risks or future should our undue reliance approval or those for upon System our operating are trends based and performance, such statements, Vicarious statements. assumptions. limitation, place these financial commercialization including various you events anticipated that differ results These materially statements. and by on from estimates those statements opportunity

in factors our forth risks XX-K associated including our with Form Form set refer Securities Commission uncertainties the of and a and list and risk the recent description For business, please and most to XX-Q. filings, our Exchange

future disclaims financial forward-looking update or July by of otherwise. that XX, only or obligation, except to information, today, required the events statements, of broadcast contains revise any call This or time-sensitive as information accurate new because or any intention conference XXXX. whether projections Vicarious Surgical law, live is

Executive that, Sachs, turn over now Officer. the to With Chief I'll call Adam

Adam Sachs

of important for call, you we updates today. number thank We've earnings to today's joining as looking have forward and to a share. us afternoon, Good been

our System. are towards strong X.X Version advance as design testing progress making we we from freeze First, of manufacturing and

Second, have we on based that mid-next intend and path first our meetings patient excited plans. series to clarity, this the to with reassurance both to and clinical announce ventral we complete procedure now a we With our are of regulatory perform in year. on FDA, hernia our submission clarity a

major Finally, we XXX. System as fourth are total partner, partners over a of to bringing our a U.S. proud hospitals represented signed have number by the Hospital to

in froze system. anticipate and design Version insights, of next progress, system system year. trial with enhancements relative the version, we we Informed clinical Beta deploying X in design previous by our to of a April number our our Starting System, surgeon incorporates our VX.X the X.X system hospital

patients. members These for system and Surgeon has recent several ahead. changes future reaffirmed system months a our motion the our profile, and optimized surgeons enable surgeon higher from Board excitement safety Luminary potential of of feedback and around quality the further our image refined Positive the immense over

manufacturing units design our development the Operating focused on coordinated verification recently promoted ensure trial, a preparation deliverables with are in Mazzola phase next With clinical to freeze, John to we in our in a V&V To our System VX.X Chief on for cycle, validation. for we and focus effort continuing and Officer.

to has he our overseeing robotics And has Operations. XXXX newly In the joined our operations COO created the scope quality and clinical organizations. development system, strategic SVP of product in John John's expanded in of for and team the previously role, was both manufacturing and regulatory include March and led year, affairs. past

company X an Class the medical involvement John launches, prepared direct then to from right commercial to our trial X Class XX for industry With device medical in clinical is drive and leader a we of launch. transition over XX years product and device and experience over R&D know organization

such, As this remains System fall. build track for X.X and of Version on the the integration

are the clarity, the the guidance Moving the on and the where outside authorization guidance grateful and trial we and FDA, for meetings, a FDA, we have patients to from States. collaboration clarity to process. to had XX as with total, on they Based provided regulatory United complete clinical patients several input with direct XX such pre-submission from plan we’ve including

the larger facilitate within the complete allow in our population ability We include to to clinical our be a us year. as position enroll procedures across and will are and to pleased data, suggestion study this patient agency's data to study meaningfully OUS next capture clinical patients with a in

a we developments ventral system these in a our plan this And clinical filing year. mid-next clarity, anticipate to clinical first driven pursue XXXX. now novo we progress submission plans, early and in With patient our hernia in procedure de by

verification our As be expected, need our as strong demonstrating the and coming manufacture This testing. addition to safely preclinical quarters. ability reliably data procedures, will in to of focus we our system to will show validation prior patient and over part to

Additionally, system trial. establish clinical we use and in the in to closely continue with hospital trial to site clinical surgeon detailed confirm our participation our the and work for partners steps

a to endpoint the our will safety After now ability the our rates clear adverse intended our follow-up to laparoscopic primary be plans post-surgery discussion hernia will to with are by existing of through needed informed ventral understanding event a of complete meet data. as two clinical These repair. XX-day safety and endpoint the objectives, the processes And the efficacy. be surgeon FDA, compared

objectives can the safety focused of that design and meet to the thrilled preclinical of patient necessary usability, phase our pathway Given with transformational these the clarity to we our we believe device efficacy Needless best the are market. capitalize our this Vicarious prove of next and on to-date, to clearly company, given and outcomes is and to the ourselves surgeon say, we numerous Surgical our enter along System. position milestones to on success

Bill? Financial will I Chief over that, call to Officer. our With Bill turn the Kelly,

Bill Kelly

and million, million, a $XX.X you year. $XX.X of were were from of today. increase quarter million XXXX of to in operating second in prior second $XX.X expenses for compared the Adam, quarter the XX% all R&D us Total second $XX.X quarter joining for million for the XXXX you, XXXX. the thank Thank expenses

and and second And to were quarter compared million, $X.X expenses in million expenses second quarter XXXX. compared the year. million marketing prior sales the of quarter were XXXX, of million $X.X General $X.X for administrative in $X.X XXXX in the of second to the

loss the period year. GAAP prior of $X.XX for respectively, This loss XXXX second per per net for net according of $X.X $XX.X a was share. of the net loss compares net $X.XX to a to share loss a million, or of million in the same quarter

second $XX.X million, $XX.X $X.XX an of adjusted prior to for year. loss net or Adjusted adjusted net the of compared share quarter period the loss of in adjusted the per net as was XXXX $X.XX per net an million, an loss share, same to equating of loss for

please reconciliation to measures to press GAAP, all of earnings For non-GAAP release. a refer our

approximately the of representing million. of cash second At $XX.X quarter, cash, burn investments end $XX the short-term million, cash and a were equivalents,

off we replaced manufacturing into development to building half drop the year, our and and be increases second expect As to costs units, preclinical the of in clinical we and move design system expenses. and certain by focus shifts

million. to the of to cash QX for continue our burn between As believe expect $XX and we rate year, we cash be the indicative the rate $XX full-year to a remainder million such, burn run fairly is XXXX

in high-value and we initiatives our advance and remain regulatory committed spending always, to processes. As only generating that investment disciplined development

closing And with turn that, for back call to over I'll the Adam remarks. Adam?

Adam Sachs

every and are you, by surgical for exceptional Bill. At Vicarious outcomes a we possible every envision Thank Surgical, surgeon. patient future where

So we surgical far this year, potential important we several vision, the development that confident and remain in the in to have transform steps approach our allow regulatory innovative and robotics. care this of taken will realizing standard toward us

patient meaningful to We our come, work our this early quarters the as our achieve fall, in System de updates submission filing to to vision of continue providing through procedures next to VX.X and integration novo XXXX. forward summer, in look this first of we

Sara? With that, operator will I our over call the questions. for turn to

Operator

Thank you. Instructions]. [Operator

with comes Sandler. question Please Maeder first from Our Piper proceed. Adam

Simran Kaur

was you update to the Bill. Simran and for with your good Hi, Adam. clinical FDA to the Thank hear regards is Hi, Adam. taking question. the This for trial. It on

of there. of to your then, excellence trial? the up able planning Are part you're or So leverage trial whether just and I'll then you number initial And not there, are to you able have patients? as OUS the that start your centers I for off thoughts a sites And guess wrapping activate to costs? any that for you of trial identified thoughts centers on share

Adam Sachs

take two Yes, the questions. I'll first

tailwind same ability the us they country data. with and work at clinical provided pleased have would the we a frankly, don't OUS incredibly the ability healthcare we're therefore to, frankly, to access for time, giving that to and tailwind fill surgical have where include don't And we’d practices US. able a simply need the in an patient enrollment, to to excellent in exist yes, have and to huge It’ll clinical enrollment the services. to same unmet good be So meaningfully

we said, absolutely excellence. to our centers use are able being of That

on all system UH sites system, surgeon of Our access. hospital surgeons are and agreements hospital And process with based criteria. the this our working provide specific for UPMCM, patient fourth we HCA, and select and in partners with to

haven't want using do on the trial. number ready exact quite at in not be sites clinical selected share so that this you we're touch We to site we'll OUS the costs? time, of this Bill, to

Bill Kelly

say, will we're think not had within actual the of expectations I these XX obviously XX we that all, cost, of we've time. terms long the to first size in for been planning patient steps But I a disclosing a cost. is well sample Yes, and

reiterate it's million about at So looking to million. our that the cash to phase. to $XX burn guidance. next keeping excited guidance we're And steps forward and next our Again, we're these within cash burn $XX

Simran Kaur

walk just you And the steps the maybe yet. of manufacturing production initial how from look systems Can need like It are And a share clinical trial? begin able process perfect. fall. through the you the the what to It manufacturing initial build many and you now will like? final for us in Okay, to follow-up. just sounds hasn't then so started to stages

Adam Sachs

initial use in be fully actually that in internally we systems the and manufacturing. underway So first are than be tested are starting in fall. we'll integrated, fall, well for It'll rather the the

total trial, the number the of exact need on for clinical it'll that the though. dozen It's the sites. of ballpark a of depend For number systems in we'll

Simran Kaur

me. perfect. you. That's Thank for it Okay,

Operator

Ryan from BTIG. Zimmerman comes question next Please with proceed. Our

Ryan Zimmerman

taking guys good afternoon. questions clarity that nice you to got and the here. the for Thanks hear Hey,

I just submission period as about the novo de but XXX-day So ‘XX, a and I after a the thinking about. put about XX about submission the think in and here, guess accept application, has the I to guess Adam, curious, to there's I'm horse think don't before then that. want want days that about FDA think The I timeline the you're I to we cart

trying commercialization some when just so begin, well with everything, assuming put to timelines trial occur, So goes around the can and can forth.

Adam Sachs

Yes, a question. fair

it that drawn-out So for The last And the clearance. know, to days, over we limit. the swift statutory we're is and continue know, providing what frankly, It's during to why agency make around not that a messing hit that for, agency work them asking year. you that de with closely period, that, – pretty questions work submission of a that is had, we get review novo XXX that with we'll closely. not that they're part We're can sure there to are many simply is all. number you so we really key exactly and we've that at the ensuring its process

want especially to respond don't but the time, especially is in pretty to we're going agency So, optimistic us, at I timing. when to guidance, provide, formal on the this

Ryan Zimmerman

FDA's comfort their the around you're discussion see of to quarter our so. expecting you feel kind enough. are nice think, But the thinking it's you where And, little the with design, it's and about patient comfortable, system, terms all that. us in down, kind of fair a last a trial on in give I have follow-up that color if what we you in discussions risk. see in again, with back your size with with and and people and was line terms risk based just including the get things what had, comments you pretty of Okay, FDA; of really I nailed like this mean,

what that And trial now clarity, of then? we and do that to and just between you need have we now now risk where kind Now completion? consider between things see

Adam Sachs

and I commentary two separate risk now way, Yes, at I'm where hearing trial until there's questions, of it. it's the kind that's how the think from along least

approval spend taking So the to full as digging advantage their so with as any the far have on they a and back are across at that surprises really system, any of forth provide to as and we us have we've the least willingness of feedback, conversation so lot or risks surprises. just and during as the can chance we absolutely the agency, our this we deep time don't minimize where that understand that can process been

were how that's that and be a least the And safety de-risk risks following minimizing timeline process. up of trial. our the process, often we truly because which And the can opportunity, thoroughly we OUS of with also know standard – able looking how to working at the how prove system, to enrollment got together bigger question of we risk patient throughout one burdensome that's is and and we the efficacy of OUS ended clinical to at while agency you prove thoroughly the to

validation it really down to and far from trial, verification now comes As risks the clinical the process. to as

that have to will that require rigorous and hiccups there's and process, the of a and we any way through So some lot meet, along standards testing that remediation.

decent time that a in that come an there have issue amount for up. would remediation. of planned be that it said, beyond We anything would being But

that doing and area. standards ton system work are We've do a a lot meet we of want designed of to clarify those do that our I pretesting. in to though,

So and we're the confident process. in our system

Ryan Zimmerman

very color, update have today. to I the appreciate and good Okay. No, it's the Thank it's you. helpful Adam.

Adam Sachs

Thanks question. for the

Operator

Please comes Josh question next with Our proceed. from TD Jennings Cowen.

Unidentified Participant

X.X itself. what place, Thanks on what had was feedback trialing on you've freeze hoping ask design Hi, of in the you this you about robotic is the of folks? Eric had and version of surgeon that or for system question. level from experimentation to taking for those I system, finalized have Josh. have Since sort received

Adam Sachs

those vX.X subcomponents in and and actually X various stages the we've full surgeons of in still testing kind system But right a system, the way. beta integration is So, final the of come along ton done now. use of

really we it of quite overall, two surgeons ton excited And QX it the been with yet. total just this So able cadaveric testing we've bring alone. year haven't overall, We're a this fall. know in to do in dozen any system give to you on including feedback had

Unidentified Participant

Okay, was then that could partner maybe chance that bit just and I even the that your announcing another a hospital new to any on about hoping And opportunity how little more program further. expand one you're about just understood. hear here, came

Adam Sachs

based what commercial. new development, and we it'll Yes, so about. partners, every one when of we're we're a both in frankly, footprint particular pretty these significant combination potential us, and provide really market excited including that of relationships in evaluate to system provides things, these on, This a trials, additional system V&V on clinical

our And thing then bandwidth. look at own really other we is carefully that the

incredible bandwidth relationships, sure and kind that's negative, system can that potential the one, since partners, to to want So why a positive making don't into one our support positive turn for course, the a have could been company and of original industry. of with we've thoughtfully that really these, ensure we we Q, work that by carefully that's in that taking But doesn't we really happen. in this they unprecedented these are actually if because these

it's your carefully. an So, really we really an question. I'd not second is, for it, opportunity do answer and There say, it thoughtfully to but

Unidentified Participant

Yeah, for makes questions. you taking Okay. the that Thank sense.

Operator

Genuity. comes question Canaccord next Rose from proceed. with Please Our Kyle

Unidentified Participant

on Congrats George the on have progress Hey, made. for Kyle. this guys is you

Just a couple me. for

at mentioned many rough of there The for so rest that the because the leeway being, about give now, the figures year. QX of first the right -- terms should guys, you you trials in think systems burn be you're And should thoughts. guys X,XXX rate units, what one clinical how of systems? cash kind around your you indicative for said it but convert I are how that much does to wondering looking of the run Is

Adam Sachs

You actuators given cost for the obviously, said probably than of systems trials? is is thing might think others systems mind have. build the decoupled design dozen our the the No, I to a to of in lower much Yes. the burden system, such one keep a the and clinical

build looking hopefully kick a systems about to the of off be we start next year and year trial so dozen that your answers into through So the this yes, as question. next clinical and year we'll

Unidentified Participant

was in the spot proactively or the of, in kind look trying wondering a if of in – comfortable Yes, are add kind where I with the then hospital in on other of of trial you question, great. terms sites? And onto I'm to partners your data partners, possible clinical necessary in you're are getting just this just wondering like, guys touched to but you terms

Adam Sachs

from the I'd say, of kind same to there answer the question previous Eric.

For adding really it the and is they that partners, we think partners. can about we that actively just value way those sure additional system support hospital being provide

in is there? there missing the question something So, I'm

Unidentified Participant

I now it No, if was just you're like you to I of – think with I and looking partners going wondering right have was guys you answered the if if you guys – pretty proactively next the well. amount are XXXX? or complacent just still, into wondering

Adam Sachs

as us that can be, to and we hospital are sure really we're as Yes, their We've really partners we how can that's have relationships because move we about those support interest with that happy that as company. right but I it we certainly make been rather a positive it to make bandwidth now. want partner, with potential think potential having the a small cautiously, systems positive, any sure lot for forward not receiving to as of we partners, number the than they mean inbound support

take and at sort we time. a one step so thoughtfully why that's of So this

Unidentified Participant

thanks. Okay,

Operator

There in back Instructions] to team questions remarks. [Operator you will Thank pass currently management no waiting for are further any the so I currently There conference for queue, are questions. questions the registered. your no

Adam Sachs

That today's so call. evening. Have the for much call. concludes joining Thank you a good everybody

Operator

That you conference conclude call. participation. will all today's for your Thank

You may now your line. disconnect

Vicarious Surgical (RBOT) 27 Jul 232023 Q2 Earnings call transcript