- Earnings call transcript Q3 2022

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

Operator

Good morning, and welcome to the InspireMD Third Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. you. Thank

begin. may You

Chuck Padala

and the everyone. financial InspireMD conference corporate operator, joining results you us update for third call. good you, Thank morning, for and Thank quarter XXXX

from Officer. Executive today Joining Slosman, are Shore, Financial Craig Chief us Chief Officer; InspireMD and Marvin

management of making forward-looking actual call, They nature inherently which, and by historical statements, beliefs expectations, involve be materially management's from the in differ uncertainties to uncertain. cause upon their results based current will that risks and this not facts expressed During are projections, may statements. and many are those forward-looking

more disclaims refer in and Commission it. this press sensitive release described periodic factors For made U.S. XX-Q these call, about recently information time that on and InspireMD's particularly reports information the risks, by Exchange this Marvin, to Form to turn the filed and Chief to or over as is any call XXXX. information that InspireMD accompanies reflect most statements X, InspireMD's only please The that of pleasure filed my risk Officer. now cautionary Slosman, update XX-K contains It the Form call revise to the publicly please after occur with in Securities law, Executive November go accurate circumstances ahead. is Marvin today, or as any call. events Except to required obligation

Marvin Slosman

for call morning. this everyone our thanks joining you, to and Thank Chuck,

momentum. We quarter growth CGuard Our third total of and third over quarter results of generated XX% last the progress reflect a of recent million, nearly over continuation revenue year. $X.X representing our

represents period to CGuard a as XX% year-over-year. same X,XXX the we a quarter, During of sold compared X,XXX systems growth the year ago. This in stent

and our is sales a majority share portion retention. distributors procedural penetration indication of a volume we markets, with of the revenue market accurate share As our in more of

new in our the delivery As remains advanced platform surgeons conversion vascular of enjoy system to across accelerate bellwether markets broadest the platform. stent and of XX%, share a CGuard will endovascular including last the space growth revascularization half transfemoral which over systems, patients. our we our the quarter, the enable approximately carotid and share territories dominating of vascular our new Launching greater with some we to focus converting currently XX% transcarotid specialist in treating than with up indicated next-generation

reminder, a all cases disease As of terms procedures that percentage estimated vascular interventions, are at endovascularly treated amongst carotid currently. lags artery of XX% other in

procedures MicroNet converted of our as that first So significant look open of years as patient mesh to when as next-generation generation data five a of to compared procedures you the now with with best device, there surgical our protected surgery. driven at far be stents and outcomes out can believe number availability remains clinical by conversion stenting, both we unmatched

all in Europe landscape under new terms for the market in the In with conditions, MDR regulatory of device CE of for remains a midst compliance sea the Mark. certification regulations change companies medical new

distributors and possible and currently customers under We with sufficient delays continuation XX, on regulation, as are which body certificate in to any the our best our of inventory process. mitigate November preparing with while compliance to the potential the as ends working secure certification notified new our

the after to an as to mesh carotid carotid benefits procedural CGuard versus CGuard and superior initiated we outcomes and through comparing which clinical X,XXX treated patients plaque of component related patient clinical compiled goals treatment results described options Cat trial evidence is all and platforms meetings featured CGuard other and with Optima all prevention CGuard was with known In significant carotid ultrasound at Therefore, outcomes Optima, of the measured strategy IVIS presentation only many Professor research artery long rate treating presentation surgery. as through the including assessment. performance the both struts remains which stent delivered multicenter be selected the from CGuard both September, TCT key of part growth residual strokes. unmatched focus medical presented Piotr XX conference on in Professor and Our stents The expose available. demonstrating by was also no a effective stenting. can findings of program. Piotr total and MicroNet in strategy body to as of a unchanged, conventional the X.XX% to this artery with with we minor specialist systemic our important the its prolapse with The elimination over currently outcomes XXXX showed delivered performance because days have of stent stroke term presence and Musialek the This unprecedented which the provides of patients as prolapse of at CGuard reviewed is stent stroke by protection Musialek major the of ipsilateral compared objective adds surgical years, proprietary performance study platform versus disease. investigator our care that

services commercialization. In we comprehensive a research we have accelerate to that contract pipeline we with strategic the Now markets, factor of our full increasingly possible. organization, new clinical agreement in entered and requirements to as complex expand market new us partnership to success serve NAMSA's technology. into other as is announced work many developments. given technology turning quickly medical jointly medical product regulatory well efficiently critical further for any development September, to Speed a will leading NAMSA, development continuum and a And and as

are U.S. pace, for we more are now Five currently are Europe. sites U.S. our that IDE in two accelerating enrolling XX patients sites is all actively building enrolling and enrolling sites In plans with terms very C-Guardians, in an XX encouraging. have of cases trial, which

with Our XXXX. QX completion enrollment approximately by remains current consistent outlook of

a An agreement executed, in continue complement we high have our partners discussions if and quarterly see year. very the interested in of potential CGuard we signed since distribution to with interest. progress China our Japan, Regarding representing would last made update last distributor level in we agreement,

we care and is past, for of Asia is the As less markets. endovascular intervention the surgically existing focused in noted have standard than U.S. dominated market very important procedural to European as the a certain and us predominantly

of drives our utilize terms utilization as the pipeline, stent drive outcomes specialist full vascular remains potential community. beyond the of CGuard, the patient the fully are device CGuard systems the EPS delivery business To delivery foundation platform broadest product we new the In across selected to of developing two option.

of device. the versions will In short and to offer TCAR those a compatible needs delivery clinical these will which the CGuard stent be continue with new CGuard platform. both in designed advance procedures option We combination, to our transcarotid developments portfolio EPS and of shaft greater development surgical system, our our accessory transfemoral standard SwitchGuard, to Prime, conversion available for of

offer of We to we the to With to toward With can believe this our forward we as to the continue stenosis outcomes call catalyst as segment. first rapidly that, standard managed. turn set potential of work best goal is Craig? unlock and how look carotid we CGuard tremendous continue of Craig XXXX over to a broader quarter review of financials. rich our care. I'll to EPS, market tirelessly patient We evolving establish CGuard the changing paradigm the of tools

Craig Shore

Thank you, Marvin.

in U.S. growth in to XXXX. XXXX, Net loss gross increase and of per for related three $X,XXX,XXX expenses. training XXXX, reduction $X,XXX,XXX XXXX of was XXXX existing XX.X% from EPS of share-based This is to XX.X%. the an primarily basic XXXX. clinical period quarter predominantly third and $XX,XXX were increase three operating C-Guardians was increase revenue expenses the Gross of for the diluted ended commencement This due and to to represents the months well and to quarter trial. basic of during stents to increased the the one quarter of same markets resulted quarter the represents expenses increases or due This XX, by to ago. of This $X,XXX,XXX U.S. Administration study XXXX. in to year increase sales during $X.XX as third XXXX X.X% $XXX,XXX a the $X,XXX,XXX, XX.X% an third third write-offs, profit increase $X,XXX,XXX $X,XXX,XXX XXXX. compensation for and sales to expenses same increase during months and totaled increase Total was diluted was XX, third quarter sales $X,XXX,XXX compared the compared for quarter share the third quarter a in XXXX. Gross total revenue of of $X.XX third profit miscellaneous driven in Food the This the the loss of ended FDA in the XXX%. the per of C-Guardians for related compared Drug expenses. net to of For for share of used in an compared $XXX,XXX almost the increase of of third period This in as or September CGuard higher September a quarter from $X,XXX,XXX XXXX from margin

as call of That equivalents deposits turn were the now XX, $XX you cash questions. bank concludes over and million XXXX, for short-term $XX we to December to Operator, As XX, will of September cash, financial compared the million XXXX. review.

Operator

your [Operator Haynor proceed And Partners. at the a this question with be time, Instructions] Global comes will our Alliance And with question-and-answer session. Ben line we conducting of first from Please question.

Benjamin Haynor

thanks for taking on questions. Good the morning, Congrats and the gentlemen. progress

for over to C-Guardians, to see enrolled it's enrollment I First safe us good sense provide you off track that on you've on where earlier XXX would in study. of for people But today? enrollment the that a additional to Could color your got there? me, the remains schedule. I any you mean, give that just imagine say it can stands

Marvin Slosman

of quarter question the our within certainly Thanks so your enrollment that I way. frame Hi, think characterize calls, the of quarter we've I quarter or for the hope mentioned enrollment. end as full it in this question. over can we would relevant, time in aggressively Yeah. prior We've the we'll first Ben. pretty that think and XXXX and for the first last by is I accelerated be

last added sites helped adding everything certainly in U.S. new are going well. to sites. is as So things over very going so according of quarter XXXX. enrollment I the had for our QX And far, end think European plan the

Benjamin Haynor

very any done potential future. XX think been I a think And quarter, there? done Where the color there you're of that of near I case Have today? then does at where first -- kind the being were in sites. talking on Great. CREST-X, stand looking lot more last cases Okay. about you

Marvin Slosman

we mentioned Yeah. of I device. little we've completed our but slow we The sponsored to And process control, are the and accelerating specifically in trial forward progressing current last than of little sites, a being these outside in with since that's a terms with these time thought. sites terms that think consuming a well. on had think of we're been call, We've been look C-Guardian and piggybacking that more getting contracts it's comfort sites has of help -- also which I in as the I certainly will as training added enrollment,

next update the more specific terms So we'll detail, I a quarterly an of over give reporting think, cases. in you bit in number of

Benjamin Haynor

And left a here, do CE you've delay, certification, That's in the long be before know Okay. is how handful then Mark got you place? there have a of I days helpful. a sense it on might that's if of

Marvin Slosman

Ben. with our worked that. there. closely estimate Yeah, to body It's very difficult We've notified

body order. as unfolds, closely all but we are things haven't documents and provide work hands closely some But as more the for we're we'll that a working But the that that the make also remain regulatory priority lot the through around basis make on we're a to Europe so are sure and with and well that waiting our been very changed order to detail, full that know, obviously, our always have make to in But it's and sufficient we've there's market just inventory a in of CGuards gotten details, are close as distributor day-to-day available. unknowns to we very there working dramatically, our the fully complexities our compliance. company you this, in we're stayed that certainly, top notified partners that feedback. we've sure As with climate in sure in

Benjamin Haynor

Okay.

the to time So is that? at you any users at what's least to this it say how you or characterize would impact fair that don't anticipate or -- end

Marvin Slosman

Yeah.

first been our has in verification. have notwithstanding the to sure of we inventory sufficient priority, I market, date the that make think Ben,

are certificate CGuard work one So as the sure is final in through that's priority to market the that make details is far as sufficiently as inventoried concerned. we the

in body, the So that's is And no our step we further devices. table will That the as delays notified be with one. work the plan. filling number hopefully, with then through there time pipeline

Benjamin Haynor

gains, some here, me digits. helpful. local the pretty dollar That's have they're mid-single the Craig? big picked XX% And it obviously, of certainly. over increased I that impacts those you euro, kind over couple mean, at have the least there been market ASPs backing then Okay. right, versus like of quarter I sound that? maybe and on out, any think XX% guys just But a currency it your you to share sounds color like more -- Does color share on that last now then have geographies mentioned that's X looks up. And currency on Any being

Craig Shore

Yeah.

with in right our of you're about the So Europe sales similar euro. the exchange, most

And we're year-over-year. look causing .And over correct across are yes, the dollar, was prices the But so at of That there can go which as we growth have it. why the up as we're trying reported. you chain But prices to worldwide. XX% number far to more supply on been So that see, actually focusing way correct. has of units market -- issues sold. raise share, board that's you're a is we as as been U.S. to strengthening

-- market. have XX% reaching of about said, of as actually our than the XX% greater XX%. company as countries companies well do than -- more as And we XX% we So Marvin some

Benjamin Haynor

And Great. Japanese for the of Okay. lastly me on interest. level then

be partner there to less more upfront mean, more Just there extent find more current loaded it curious a royalty I on likely, loaded over terms a the kind once thinking can likely or with there, to are are more back-end that you -- you do what's or of is that a -- it's or share? the

Marvin Slosman

Yeah, Ben.

considered aspects two, over three to did I any different think path participate that last consideration. is One with sure expressed of distributor to or could us that, China agreement. they're regulatory year considered that three sure partners making in as the we we and the that of as path that be clear obviously of prepared have maybe regulatory and sort so make was the part

of we those signed their Second of as also to an their well, is, generally But that, the then standard in of also reputation which it approach beyond looking are within consideration China things. numbers obviously, units, follows royalty at a carotid and we And to was consistent agreement. investment numbers capability years, distribute kinds stents kind the marketplace. of of when that

on we've three well. those considering. got than what so as So we're And interested are more details. party, I good one said, aspects that's those as And we're working

those So we along hope lines. to information have some new soon

Benjamin Haynor

Okay. Great. that's Thanks progress. taking Well, congrats for had. questions the and the on I all again

Marvin Slosman

Ben. Thanks,

always, it. appreciate As we

Operator

to have Slosman end back I'll remarks. we session. call the closing of turn the now reached And over Marvin question-and-answer the for

Marvin Slosman

momentum year-to-date, the as XXXX. to much. into you. the We're and like look we join continued the strong and everyone quarter finish I'd to proud very as Great. to Thank call taking the thank time forward ongoing today for support. well of from extremely a this progress Thanks

Operator

at today's time. for concludes your disconnect you you may lines Thank this conference, your this and participation. And

InspireMD (NSPR) 8 Nov 222022 Q3 Earnings call transcript