NSPR - Earnings call transcript Q3 2021

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Operator

Greetings! Welcome to InspireMD, Third Quarter 2021 Earnings Call. At this time all participants are in a listen-only mode. [Operator Instructions]. Please note, this conference is being recorded. I will now turn the conference over to David Holmes with LifeSci Advisors. you. Thank

being. may You

David Holmes

and the everyone. financial InspireMD conference corporate Sherry, 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 light making forward-looking call, pandemic. of address the statements statements, operational and be future for COVID-XX expectations performance will results, this including that During InspireMD's particularly in

that may from Forward-looking cause results statements other involve materially risks to those factors statements. and differ actual

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

Marvin Slosman

awareness to artery joining protection, like yielded and Good and its are this disease care proprietary to establish stent today change design of I'd is solution, through is managed thank growing you, option artery the serve treating all body of ongoing an our prevented. physician clinical as standard mission real-world with We as MicroNet system you Also carotid CGuard change practice patient Financial strokes at carotid disease of to and XXXX on outcomes. of system way the the first clinical well the stent mesh morning our and Officer. with has as create studies. advantages equally and carotid in of greater enables evidence this a total the line call. systems new focus me specialists unmatched which as of $X We EPS The invasive physician We and unique enable which CGuard surgically Thank third billion Craig conversion as David. all advanced as care. well the CGuard market for quarter InspireMD, joining believe Chief reiteration to endovascular Shore, dominated begin delivery we is to the a global accessory broad of addressable can standard less solutions. base,

meaningful differentiating on our The of in our all evidence, with layered deliver stents market, generation other body and EPS cerebral of JACC statistically in peri-procedural of third quest and of proved a reduction dual Abbott's to first the XXXX publication growing further quarter clear CGuard generation the comparing favor from against CGuard. significant Randomized in with a Acculink in embolism differentiation Trial celled in XX% approximately of open CGuard first

discuss We this will results further the breakthrough publication later. of

grew build in company XXXX. the Additionally, expansion, for in pipeline offerings. sales and over same the while nine global for market demand and traction year-to-date commercial business development CGuard, XX% to increased XX% for CGuard we objectives our Commercial gaining period continue in quarter months year-over-year growth of the of

average compared served normalized French into the levels to cases During announced markets. to to for previously Authority most XX% procedures the the XXXX, reimbursement with launched completed selective combined key with greater in National process market first expansion accelerated Japan France. Strategy the United an our and Asia have drive control CGuard our we sales sold Kingdom capture of quarter demonstrated amongst sales continues also our from received for in plans enable as growth, the to efforts subsequently our distributor clinical CGuard. the price XX we previously in and with new now devices, commercial anticipated CGuard of in These in approval we the Health interested higher representing talks and in approval points quarter In into direct week increase sales to of scheduled France X,XXX advance locations, have of post approval. as inflection markets to third strategic with in have the of French partners

agreement of procedural accelerated and noted less consistent is previously we months surgically opportunity predominately intervention offers the Asian endovascular an for and ago, standard I several CGuard As our market care with for in the believe as focus dominated. China existing

CGuard, establish and with addition with Additional and greater U.S. trial commercial we to the of of C-Guardians FDA physician planning base leadership including our operational U.S. a advanced experience are infrastructure. in enrollment business,

XX% U.S. by Speaking completed over led Tennessee. at Investigator, the Ballad enrollment Systems global of in Dr. C-Guardians trail, Chris eastern to-date, we’ve Health the Metzger Principal of

Abbott reduction embolism generation both following of of of for to prior against the of we As leaders, encouraged a MicroNet-Covered favor cerebral compared the foundation significantly Most thrombus the Acculink to Acculink through alternatives X.X utilization in stent advantage we other following comparing of Abbott randomized the trial of stent MicroNet cerebral procedural consistent reference our CGuard, peri-procedural test. evidence CGuard number to during and in CGuard the our lumen and The the mentioned the of as launched this with found and protection lesions foundational approval a in launch. dramatic reflected further are the important and favor volume in CGuard test of commercial ipsilateral DW-MRI publication migration related EPS test, this of advantages [ph]. measured Experience trial, all in delivering prevention plant of mesh us the with embolism Investigator to was the stent of CGuard. ability in vessel tests remains stent credibility events of both and reduction accelerated against prevent trial the a in fold with study In following cerebral publication the CGuard by top the first post carotid positioning the U.S. the and awareness by successful growing

While Acculink neurological occurred procedural Abbott the protection arm, not there of ipsilateral suggesting show occurred further study no with to MicroNet was the statistical the observed from the value post strokes outcomes, CGuard the mesh. of in but two clinical powered significances were arm, which events

Our investment enable new advanced test tools procedures. of with continues pipeline innovation to our in more

with Our of of surgical accelerated alternative our our stroke as continue progress way stent. to significantly objective in our future demand first with With to execution clinically conversion and as double carotid to and delivery for and will Craig, a carotid will we’re will Craig? view global priority turn invest which generation the stroke CGuard To previous that, change next who market greater surgical potential mission prevented system patients is I'll from over is CGuard to surgery. our carotid by and proven leverage we invasive in in managed our approval continue the drive well quarter financials. endarterectomy, establishing to new To compared types, call managed summarize, to re-chart XXXX, demonstrating as continues we conversions facilitate course progress conventional encouraged the our CAD EPS layer overall the disease tremendous of as procedures the or and reflects in prevented. endovascular with address open as of stent system, unlock which artery procedures anticipated is growth, mentioned quarter the how systems to clinical outcomes new stent believe superior foundational enabler endovascular for will stents, and a growth such

Craig Shore

joining and everyone today. Thank for you, to Marvin,

affected $XXX,XXX of X% XX% ended third procedures the revenue some Here was XX, ended last increase began of CGuard $XX,XXX revenue ended sales quarter with three XX, This mainly ended due offset key quarter procedures EPS XX% Total increase were a MGuard was EPS, cases, are XX, return decrease XXXX the $XXX,XXX scheduled financial COVID-XX. the had somewhat levels same EPS the sales additional XX, from September by months CGuard period in highlights September for quarter of during EPS This to to ended increase for resources September to sales the September patients of to as hospital with during are for by tutorials three year. normal XXXX. months September to as three increase this when compared postponed CGuard of EPS months shifted $X,XXX,XXX, still an $XXX,XXX and three the XXXX. to XX, $X,XXX,XXX, was CGuard which an months XXXX from non-emergency of generally during for partially to in XXXX. the compared

issues, split three period and XX% expenses XXXX September months costs, just September to XXXX by the ended to was XX, stated. increase expenses XX, during resulted in September increase gross profit production ended in in material ended XX, margin This and in gross compared volume XX% $XXX,XXX had XXXX from of reasons increase to totaled XXXX. diluted in increase and $X,XXX,XXX quarter months a during Total XXXX This XX, the basic we $XX,XXX and mainly The X,XXX,XXX the average the calculation share or XXXX XXXX. earnings XX, $X.XX related QX reflect period September $XX,XXX adjusted loss mainly an a amount same in XXXX increase of the and as XXXX; three three insurance in the the new shares the diluted sales accruals product EPS and expense. to of to the in marketing compared due decreased $X.XX due in the increase by an during sales the Gross compared used per or $X,XXX,XXX driven term months us the X:XX additional solutions; Officers’ due per in during on reverse of and expenses QX months primarily $XXX,XXX offset were expenses for basic an the $XX,XXX from XXXX. since supply increase $X,XXX,XXX three of sales profit was increased This $XX,XXX loss Liability expenses to our sales a $XXX,XXX to X,XXX,XXX of outstanding operating for September write-offs expansion net same to increases study; effective well in decrease and XXXX. development per due employee both in of new of overall industry XX, in expenses for X% stated. share, partially to to per third previously XXXX, associated revenue, CGuard C-Guardians labor decrease for short and the $XX,XXX a the Net April in XXXX. volume, miscellaneous of $XXX,XXX for training development to with months $XXX,XXX miscellaneous a trends and due of ended the cost the $XXX,XXX recent ended delivery system by expenses ended accessory the three premiums increase costs in caused XX, in and resources September $XXX,XXX quarter $X,XXX,XXX, by unit, and were salary markets; due commencement in compensation-related For $XX,XXX increase of of component $XX,XXX and increases XX, in new of associated expense related grants with to mainly infrastructure; share-based Directors’ of FDA in made due Insurance recognition August to share existing

XX, of as cash, over like XXXX, of go compared the questions. I'd deposits turn million short-term December that, September cash bank XXXX. to call Operator, please XX, equivalents to million were now and for ahead. As With $XX.X $XX.X

Operator

Instructions]. Thank [Operator you

Ben with Partners. question proceed. first Haynor is Our Alliance from Global Please

Ben Haynor

on for all Thanks taking progress. questions the gentlemen! congrats and day the Good

First off sites for talk the are just all bit on trail, enrollment. C-Guardians other about opening from the little track you a can me, on

You the know you when and all to running? up be do kind expect sites of

Marvin Slosman

Yeah, hi for Ben! Thanks question. the

up and set. a everything all you are are currently and sites in sites completed process another by Plan have the aware place of So contracts The bit as four complicated terms we be the of to end to four that is and in have the enroll. approved ready may year. getting getting

the sites by I enrollment total around in year total the purposes. end seven think we'll of be So or eight for somewhere looking at

heading going, that during will it of a progressing, and done. So getting be cases and then process part

Ben Haynor

And it! obviously. that great on Got SIBERIA looked then the data,

gotten have since clinicians you feedback any know can discuss. You the publication that from you

Marvin Slosman

we in actually JACC is Yeah, solid publication as well. other certainly but most recent we [inaudible] recently than and fact just the nothing that promote attended are trying commercial week know organization, TCT to the you in next and our that it's a

a Abbot absorption certainly overall So the the well as and we're will of very the both hopeful randomized that trial just outreach result the industry be was Acculink by physicians with head-to-head by an and us, important it this event as stent. for this positive because and was

So in our it data. we’re using and really pleased with look clinical forward line the advance to information story to

Ben Haynor

the anything in surprise that whether mean sense. curious terms just Is coming pretty that, it there's me, out fantastic of on I your makes of looks but surprised you to there It any end. from performance.

Marvin Slosman

part think from observed the what I the the fact trials. of investigator the taken continues beginning it Ben that Yeah, from we've trials that the great have is reinforce to place, result very initiated

As in in performance reiterate just stent in a the no the these patients work head is previous you enrolled CGuard, consistency know continues shows it as surprises of got good well. X,XXX and to because performance just which we've about stent, different the Abbott the Acculink of but it of actually quite context efforts

Ben Haynor

there? about like kind of a the are I you and in in you're those as up what then at Okay, Asian and Can overall, running bit but more at talk about ASPs bit XXX a roughly you know the that France talk sense. makes see Then look little bucks of maybe are kind developing. where opportunity it France. all little the you

Marvin Slosman

so is somewhere particular in French $XXX Yes, of this reimbursement market for around category. the terms in reimbursement

us a go for obviously to full allows the which model obvious the there market. to reasons, Our ASP, but on benefit of direct us gives the was control objective sales also

particular to sales a effort to sense in case make transition So made the direct in good France. that it

terms and have three best sort we've distributor what to quite in trying now, us. approach, as I to in In Asia, the of in it’s very out terms But which significant Japan of Japanese and of forth. it's three so partners very your all our question process partner strong nice of the got options think in was second play Asia, relationship a for which interested right are is market a interested are

the by best we're and to that continue negotiate So encouraged we’ll option.

Ben Haynor

new the you it, that two on other you then and systems delivery color any earlier? Got can that mentioned share

Marvin Slosman

we're I'm hopeful of that bit We're the in premature. and little systems to certainly terms Yeah, commercial It's sort are to future I and anxious a those strategy soon. delivery way It's to great frame our regulatory but talk openly progress. overall pathway of edges commercial about more the to coming we just and able talk mean that. what strategy, pathway be I'm in the making rounding going about would that, near

Ben Haynor

my tuned. stay I favorite know of it’s Okay, questions. one

Marvin Slosman

are asking want we to it. you tuned, I Ben, keep Stay getting there.

Ben Haynor

all I for Thanks taking the Marvin. gentlemen. We’ll that’s Thanks questions. had

Marvin Slosman

it. appreciate Thanks Ben. We

Operator

There more I no time. to questions conference back for at Slosman would like closing are the remarks. this turn over to Marvin

Marvin Slosman

Thanks call taking very much. to everyone for join I'd like the time to today. thank the

efforts fundamentally Of our creating in proud about for really ever today the future course, our extraordinary the Thank than company. InspireMD I'm before. encouraged is very exciting We're a stronger of team an of and you. future expanding company

Operator

does This conclude conference. you. Thank today's

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

InspireMD (NSPR) 9 Nov 212021 Q3 Earnings call transcript