NSPR - Earnings call transcript Q2 2021

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Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the InspireMD Second Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. Instructions]. [Operator playback call being the Internet broadcast is recorded this conference of and advised being is call live for are on audio that this also Participants purposes. over the call A webcast after end the of be XXXX. approximately through XX, one the November will call replay hour available the of

sir. the now the firm. Relations company's turn to Jules call ahead, I’d Now, to Abraham Mr. Investor Please over like of IR, go CORE

Jules Abraham

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

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

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

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

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

Marvin Slosman

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

commercial the momentum The new productive in improvement gaining for normalized commercial Revenue and X,XXX,XXX second achieved elective year-over-year. grew. showed quarter of consistent of offerings. growth XXX% quarter, second for quarter our pipeline the development as traction expansion, performance InspireMD, of growth milestones our and a XXXX of global proved procedures highly for revenue We execution

in Ballad XXX Chris of the Metzger the registration XXXX, completed targeted eastern XX devices, United of total with trial. weeks, CGuard our our toward scheduled top to of commercial in began Tennessee. Of During the Investigator, priorities States in steps levels. of the most first renewal the pivotal second compared of three with Systems Health we pre-pandemic Principal XXXX as to in quarter, increase enrollment sold an we our path notably, return Dr. of the cases and XXX% C-Guardians at global led the X,XXX quarter We've by stated initiation a for procedures

United utilization the a at CGuard, through in carotid the launch and States approval of commercial credibility which successful to stent foundation look planned we establish and the the sites of for launch. leaders, awareness XX accelerated post trial top will we with As us and a position

we the our In an opportunity believe of expansion the to and dominated. received our weeks in French existing markets to with market into for surgically as in our care Authority CGuard expansion, is approval the China CGuard clinical progress with We Japan, execution UK. as in plans and endovascular global for our trial launch accelerated of anticipating coming along partners distributor and next standard intervention regulatory new for we've progress such National for working Asia, continue approval terms focus Korea. from reimbursement with the these markets procedural plans, on offer predominantly Health In sales along the enable less France, are and direct Taiwan

new than and evaluating Directors guide developing current commercially Board strategy with business strategic and Katie we joined development. other executive, To Medical drive Advisory two shape leaders member company Board plan Directors. Katie's are will of our our knowledge be and more Seasoned and to device possibilities and Committee MedTech commercialization sales our opinion of and We of progress. offerings. industry in sales our invaluable our average our decades Arnold helping and price formed marketing in a expand more with direct leadership higher growing the of commercialization of globally, control efforts key a appointed to enhance medical

Dr. need, Rosenfield, and Board. new We will the Advisory also guidance company's Board as Chair growth provide the advancements Medical and clinical strategic Kenneth appointed on The acclaimed planning of and direction technology the interventional cardiologist, direction.

that and our in procedures. to pipeline enable continue innovation We invest platforms of advancing CAS more heavily

our in two which potential development facilitate market overall delivery accelerated XXXX, to believe address new will specifically greater global approval systems to access advancing the possible a we the that in carotid have We surgical of To we as establishing progress procedures system the conversion stent with of enabler focusing to conversion. stenting. on summarize, CGuard market are stent foundational pleased the endovascular

markets, States Asia the the through with served current process in trial foundations success. commercial regulatory building future for XX market are of in awareness our and along Our and focus United building experience execution CGuard and

is is second we financials. we’re disease surgical superior to our I'll chart artery CGuard compared As with the new and for conventional artery our Craig? continue change encouraged types, generation clinical clinically With by such progress turn managed the and as and potential leverage stent way how the and mission alternative to in outcomes managed call unlock invest to procedures, quarter Craig review demonstrating our that, or we and as prevented to stroke carotid stent future to stroke our over prevented. is as well is double tremendous in system, invasive proven a to next patients course carotid EPS layer carotid disease endarterectomy,

Craig Shore

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

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

less an the $X.XX in This offerings decrease ended caused to adjusted loss driven for profit by share, $XXX,XXX accrual that $X.XX material XX, were the of grants accessory $XXX,XXX, and second write-offs XXX,XXX expenses salary in for in and of XXXX and from expenses and the June effected a For share-based $X.X temporary June to and by to XXX,XXX the same increased in the as C-Guardians the XX, to increase for implemented and same related recognition from stated. decrease outstanding additional for XXXX $XXX,XXX during gross of FDA June XX.X% earnings basic a million our or increased $X,XXX,XXX, supply components ended increases we The with mainly miscellaneous sales amount quarter a driven partially were X reductions due which revenues expenses $XXX,XXX resulted $XXX,XXX CGuard $XXX,XXX underwriter diluted as changes made ended basic loss premiums XXXX. XX, compared the a prior months expenses to period period operating same for and primarily QX June months three the $XXX,XXX a per was $X.X XX three with margin COVID-XX XX, was Gross XX, This diluted to in share increase June a of infrastructure. increase compared of associated XXXX, XX, the due by of XXXX. net the in increase had ended us related labor Officers’ XXXX, development months for average salary to This in in for million, April effect trends related shares to resources months expenses split to our I agreement an in by Directors’ Total insurance per overall Net reasons ended after EPS $X,XXX,XXX, response on product in of the as XXXX and million during expense period profit mainly XX.X% recent in and calculation a three in used year. to primarily three X.X in study, well the three issues. the the during reflect development are increase months quarter Insurance in related negative a of the reduction totaled Liability due XXXX of mainly revenues, or solution, expense and by the on gross the of to of in were occurred $XX,XXX the commencement settlement to during June QX industry. XXXX. months compared similar of XXXX expense. relating just expenses of gross the which costs per three XX, of a offset the compensation last reverse $XXX,XXX XXXX, in share, XX% both loss $XXX,XXX

of XX, that, please compared With cash to As as December cash $XX.X million over Operator, to were XX, $XX.X the like ahead. questions. XXXX, go and call of million I for now would XXXX. June equivalents turn

Operator

[Operator Instructions].

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

Benjamin Haynor

for Good taking gentlemen. Thanks the questions. day,

on to on and started, trial -- just C-Guardians the great me for off First that's the getting first, well, congratulations see.

if able know nature procedural On the patients are you can enrolled so all, so you've talk kind how of these at that measures, I don't about would or any scheduled, to that but things might cases times, imagine be there of I you far, that share? non-outcome dozen procedure -- are success

Marvin Slosman

Yes, for question. Ben, thanks the

So It's Metzger has appropriate cases cases, Chris far, particular as and thrilled gone actually by possible. quite many with the has and accordingly we're aggressive to case in use the this excited as number Dr. of that he's enrollment scheduled. an schedule, CGuard

cases So try this the the was to phase our as and soon we're looking as trial to and pace, possible. to forward intention which accelerated in our of to enroll always an that completed continuing hope trend get enrollment continuing

and cases been that so three within the of month. sites really it's terms it's usefulness plan exceeded on have of our CGuard of two enrolled, the So, expectations in the and to next bring been or more far, number we --

So more get to people it's a now move enrolling.

so so So, good. far,

Benjamin Haynor

himself it by enroll looks Dr. could way jeez, Metzger the going. almost like he’s Well,

Marvin Slosman

He certainly has cases. the

Benjamin Haynor

Okay.

completely on XX bit. first that can know you necessarily just not working -- or cases things a through are is that Was I there of not but he postponed a that so that's elective little mentioned? So kind they're there procedures, be backlog those

Marvin Slosman

so out that we trial, No. XX to be amongst the in within want He find the the get operators spread but the of to diversity a volume. has related to nice community. we wants to done the certainly kind But work other he appropriate obviously cases U.S. the that

number has often he's he cases that of just So doing. that

Benjamin Haynor

a questions Okay. he And CGuard week, day asking a them? how or does maybe does And schedule on to I'm each too do or he tend this. kind many of like,

Marvin Slosman

patient-related of and it specific Yes. Most case-related. is

And, patients. said, you elective. the of are his evaluates he these majority So as

defined to he's it goes cases committee then do thorough And process review. able evaluation, a get a so very to for which a of It's enrolled.

high has he so a and accordingly. schedules volume And

So it be just the significant. is to happens that volume

Benjamin Haynor

on system protection I device, the Prime new you assume and that the that the of kind device. kind assume What embolic embolic the just thoughts protection share trans-femoral Okay, about make improvements then just of procedure it's color to plan the are makes the on is And in I it the nice of there Is hear device, offer the to the docs, delivery it's greater the capturing sense. easier CGuard and there? with then that can there? a

Marvin Slosman

Sure, Ben. It's a great question.

previous specialists carotid whether mentioned appropriate in managing current that's to objective we sure any have I've calls, As or that disease, is the focused. for artery surgery delivery they're systems in make interventional interested our

set just to feature we're So sure is for process make that trans-femoral delivery we that our make we system device in in continuing that systems the it's improvements approach and look a the trans-femoral believe objectives Prime next that will those and pipeline. physicians, always next make that to generation the match generation that just CGuard the delivery easier

other company, a just at by details delivery system. we device, you little progress. premature particular, the in the of point really specifics pleased In that for we're And significant the that this But surgery vascular endovascular let's this terms it's of share the know. goal of the as incredibly to say a the enable believe which conversion is will, procedures, over to this of

and we whatever systems specialists. to first delivery don't patient all with we're focusing with So available system management, we CGuard. disease our solution on sure are about amongst are carotid involved to sure make their and want to make sub stent groups. want line the that they're If that artery discriminate outcomes, We

Benjamin Haynor

sense. made just device, ergonomic or digging improvements -- sort of maybe on And you the the improvements, those share? little Are if can of makes device. on then they been a trans-femoral a deeper lot that bit kind Okay, the of of improvements what have are

Marvin Slosman

Yes. from of handle has. plan design and any solution end-to-end aspect company We've the at taken catheter that every device every development and multigenerational good tried kind product device. tracking to look of in feature the the We through an

to delivery it as trying makes how that are or really functional sure we're of end-to-end so performs. CGuard physicians easy from up make to And comfortable acute under as symptomatic as with just even and system and cases as it cases possible, the where just the that it's very delivery step possible, the device

So been the on we've we those direct way it's be. really the physicians, should been improve, guided end-to-end device and sure get be. And to look from at is that it feedback comprehensive that making wish a is our should obviously, as it which things

Benjamin Haynor

or thought outside me prior Okay, for would then But those that XXXX. can kind of great. of well get And Does guess, just lastly to Mark in CGuard, imagine FDA by of also that XXX(k) the kind for are I you cleared you as U.S.? I mentioned regulatory the the only CE there? approvals the clearance what's encompass products sure.

Marvin Slosman

Yes, the all Ben. we're evaluating this at options point,

regulatory at as keeping changed of we're MDR the Europe lot these sure up the know, and a unfold. devices and they are has But looking you we comprehensive certainly a in making CE with the As that conversion for markets solution evolve Mark of regulatory landscape. the both and

both So we're of in potential. the possibility looking at and terms

Benjamin Haynor

Thanks fair all this have Okay, enough. I and for congrats a lot, the progress. on all That's gentlemen, morning.

Marvin Slosman

Thanks, Ben.

Operator

question-and-answer This closing call. remarks. concludes Mr. now the session of I’ll call Marvin our for Slosman return the to

Marvin Slosman

the company efforts results very for much. to future. proud stronger a extraordinary and everyone before, look quarter is you. the to ongoing Thank your of I'm creating of the team thank to time and the for for excitement third company join everyone fundamentally future and updating on today support. ever than I'd Thanks InspireMD taking the expanding our and forward like today the very in

Operator

you conference Thank is for now attending today's The presentation. concluded.

disconnect. now may You

InspireMD (NSPR) 10 Aug 212021 Q2 Earnings call transcript