NSPR - Earnings call transcript Q2 2022

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Operator

Good morning, and welcome to the InspireMD Second Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this conference is being recorded. I would now like to 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 Second 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 and Chief this accompanies materially law, X, it. that release call please of today, disclaims to making update as Commission, forward-looking my call, actual made any call, InspireMD They nature, inherently the which, results events and and call by in most forward-looking reflect described pleasure differ with to of on is particularly occur or is turn contains historical expressed Securities InspireMD's in press to required by statements information Except statements, beliefs from risks, as U.S. time-sensitive expectations, involve filed be only The the XX-Q reports management's call. uncertainties circumstances InspireMD's the uncertain. statements. those cautionary publicly go that these Exchange cause accurate that XXXX. upon to Form about the please their based ahead. in the current any will information or after Slosman, now Form Marvin, revise XX-K Marvin this obligations recently Executive periodic to Officer. It that More risks risk over and information this filed refer not facts, During and are projections, may to factors and many are August

Marvin Slosman

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

sales reflecting to the volume to ignore System. units in CGuard protection to measurements MicroNet to a our more million, These performing the of second Embolic our all versus of also and long-term design robust continue strengthening open sold short- out unmatched X,XXX top innovate standard believe we is novel in territories. with outcomes, vascular treatment and QX now quarter year. represents territories through layer line enabling market share ASP care over as sold a a majority execute market the was acceleration is partners markets This surgery. growth proprietary of patency we runway devices prevention. demonstrate to double compared some platform revenue as of on growth, consistent including of in to the The With of five well clear in with dollar and tremendous continues a stent of sales best as to shift other stent X,XXX the new the highlight move increased of for Stent to and carotid endovascular to When of with currently XX% data CGuard years in mesh half up additional performance. market. last actually with direct U.S. which market penetration you those XX%. clinical units momentum revenue which as features second our accurate penetration is XX%, an this quarter. represented This our driven revenue superior the quarter business the of greater of than paradigm more mission indicator surgery by and our successfully the we disease to During sold drive as compared versus a model and to design carotid this We front we create stroke open totaling in XX% with enables of us, of increase was The share XXXX artery approximately continued of volume X,XXX will units establish XX%, CGuard by nearly of in euro $X.X quarter, convert This our Prevention procedural distribution last the certainly which markets. reflective

from endovascular growing further disease Our XX% the surgery cases endovascular open is procedures. treated than to with carotid through standard stenting are of you bolstered currently of position artery transition consider care less when

carotid consistent, we forward convert surgery a to both strategy our is this all as believe of endovascular remains percentage stent specialists a carotid endovascular and leading a surgical look focus relative So with evidence CGuard there promote large which growing procedures well conversion. significant open device. can Therefore, as competing remains converted be superiority we treating of of clinical CGuard and alternatives, artery on to that to as body first-line and treatment to the therapies from to demonstrating disease

other attention milestones. to Turning our quarterly

delivering The addition live The male University Germany, Our past demand. June, conference meet cases asymptomatic this on and performed case Dr. a CGuard. Interventional demonstrate successful was for Leipzig opportunity an held result. as medical CGuard as transmission carotid Dr. important progressive such remained well market the We LINC, Leipzig, successful case excellent and in Course, a internal live to this at to live Schmidt presence the LINC at year, KOLs important with Fischer procedure in angiographic format presence to presentations with a us in XX-year-old Andreas at a featuring as influencing X performed significant an Andrej stenosis. Hospital the had by calcified

opportunity of of to gave ease Europe CGuard's the from not conformability also protection innovation. but superb see mesh Importantly, its MicroNet the use, and only the firsthand treating case across vascular specialists benefits

performed XXXX, the endovascular develop be first as TCAR the guidance the Dr. standard an speaks and CGuard the announced Parodi benefits currently from patient improve surgery prevention that to underway. open procedure carotid to company. useful for cerebral of volumes adviser is other the long-term world-renowned vast adviser in And latter and Juan few we a and unique having our relative Dr. about believe ago, platforms agreed experience, transition weeks Parodi's procedure stent a disease Just of Dr. Dr. of protection. of be The first-ever and to pioneer, carotid we Parodi to as repair XXXX, is technology flow using reverse Parodi market. stroke has perspectives solutions outcomes. on the advance a to new in management endovascular strategic we care supporter will endovascular having

Turning now developments. other to

terms enrolling this that All one sites of currently is and sites first U.S. XX IDE more, plans pace, we opened U.S. In for are accelerating cases is in last and we have expected encouraging. We begin building five. four to C-Guardians, now XX Europe, quarter which enrolling and at total trial month a our with of an cases are has more enrolling patients, our accelerated. indicated site European for four trial, enrollment been sites

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

a Regarding high China Japan, once in pleased year. level agreement are ongoing, have signed would interest. An was representing potential the and of with discussions our in that distribution last are be complement distribution we interested seeing we to executed partners agreement very CGuard

be most the announced EPS market important us dominated very certain CREST-X existing standard a a is endovascular of intervention we which as yet patients scientifically to advanced is prevent February, European our disease. of another arm technology as investigate in and that validation to as carotid acknowledged the significant to such XX CGuard approved market procedural widely of trial, U.S. asymptomatic an would Asia we CGuard patient strokes markets. We've less for than this participate the In and ongoing stenting surgically trial care sites for be course significant predominantly the to important to the We use for optimal STEMI an included platform treatment the anticipate completed of important first to and completed treatment soon. focus in be and effort. readiness is the for as with treatments view option

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

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

Craig? work of in the outcomes set With paradigm of we turn this I'll goal the tremendous how our unlock potential managed. EPS, call tirelessly best the for toward financials. rapidly the a the of carotid tools Craig With segment. CGuard our to stenosis quarter to is patient of evolving offer second broadest that, continue to changing review of believe over We we can market

Craig Shore

Marvin. you, Thank

the resulted and second from quarter trial. sold CGuard trade or commencement due increase study, the a in expenses for increase XX.X% This in This from related the of FDA shows, was to $X.XX and profit the XX.X%. in to and represents mainly XXXX. Net million of the months and Administration U.S. reduction for occurred $X.XXX one the reduction second which offset XX.X% during as million occur For XXXX. $X.XXX for operating June XX.X% stents loss to to during gross $X.XXX an current Drug goods diluted and partially period in the for to $XXX,XXX increase predominantly miscellaneous in June an growth quarter second sales markets $X.XXX million, compared existing the of ended million diluted XXXX, million share Gross the Food XXXX. of Total new second months quarter increase for totaled $X.XXX this $XXX,XXX second well net was U.S. XXXX, XXXX was used share resume quarter of million related compensation. the XXXX. was per due compared second quarter as the revenue to in volume three adjustment XX, was sales in C-Guardians for clinical per to of increase and of second This an in basic June the CGuard during $X.XXX by quarter and of increase for for of XXXX of in expenses, did of $X.XXX basic XXXX. of due a three margin XX, to the inventory same the profit a driven million months to XXXX second higher activities same of cost million not ago. a quarter $X.XXX share-based This year quarter ended increase primarily EPS of period. loss increased XXXX travel Gross to from were revenue XX, ended period compared the of to for by or the This million during sales $X.XX $X.XXX XXXX, compared that a increases three expenses

remains ongoing million and XXXX, to the equivalents bank new to sell as Of rule were of deposits in the million certification of cash XXXX. of CGuard short-term of there changing uncertainty As of $XX under XX, cash, XX, timing specific June to $XX.X the structure. Europe the note, December environment MDR regulatory compared renewal

body remains to call without would now focus secure like work with any to the for the questions. notified to delay. turn operator our I Our over conference the to renewal

Operator

Haynor is Global question first The Partners. Instructions] from [Operator Ben from Alliance

Benjamin Haynor

Congrats progress. on the all

distributor First little most bit sequentially. a guess, looks you math numbers. the out you've other on doing due And it you then you which bit. gone off doing comment ASP is element a just countries? there? far me, like I also QX geographic I'm that But little presume that direct how in countries the the a also right, thus in was for the of to I currency, to called If declined mix there are relative the guys can

Craig Shore

Craig. it's Ben,

question. Okay. Thanks for the

up So that because was grew XX%, actually a it you about, if was mix, material. slight Marvin spoke in revenue There look and units only the XX%. the XX% our was we impact, predominantly it but wasn't exchange, change at

turn it over on you I'll the update and Marvin can direct he So now an sales. give to

Marvin Slosman

for the thanks Ben, Yes, question.

direct in model end we the in the to France, of and expand the So and toward are plans beginning that of next likely direct year. right UK now, the we have year,

color the up by those will partners. come buttoned next some process likely of as those on as distributor in with those certainly, openly get those territories transitioning more our we But quarter. yet of announced we're haven't We

Benjamin Haynor

in it. I or wondering as the repeat, of but Got all procedures. then that's seeing versus share maybe platforms market to stent remarks, there. Okay. other revisit share growth could growth the you're the And And carotid XX% a carotid statistics if mentioned earlier was you prepared XX% not you

Marvin Slosman

Yes.

off it we calculate we when procedures. So market calculate share, of CAS

XX%. stenting surgeries. competitors, carotid markets, of as procedures And to So we over and in some in we XX% mentioned, versus than not our up have more share, open cases, XX%

penetration, market within we use a commercially. guideline proxy environment, a certainly as we this to and but stenting of our course, that converting important as overall look to objective, is the current and at the equally market, So CAS goal CAS a expanding growth surgeries

surgery percentages gain So it's segment. sort more stenting transition within those stenting and existing of the two to pillars, endovascular higher share

a So marker big for that's success. our

Benjamin Haynor

makes sense. competitors looks clearance. of of your Thanks you to with seems you of things European have for That any of Kind it TCAR it like clarifying procedure. there. the yourself side one have that may Okay. pursue silo kind going that And on And is guys guys on that? not market then to regulatory thoughts the

Marvin Slosman

within option. European considering ongoing an is the TCAR that there acknowledge alternative certainly delivery need market, We an for Yes. as

more use a and many direct fact, of the access homemade vascular surgeons In they that things prefer, to carotid. kits other

the to transfemoral of with to more drive an market think So system. X continue those certainly will things we're I that about stenting. combination excited alternative And serving our

We toward surgeons we're our procedures stenting surgeons to an excited of system. available the XX% that by within transfemoral about CGuard rate use solution, well, option. with option of vascular transfemorally, have even a within done We fairly somewhere drive we vascular as the now but everyone for guess high a best TCAR around are conversion European so being as community the that can course, overall offering

have So opportunity. to that thrilled we're

Benjamin Haynor

it? update, is to Okay. but there, on on track for C-Guardians. the the efforts about way on the think missed still Great. Switchguard, development Prime enrollment and And Maybe those still thanks right you're CGuard then track for remain the I this, for

Marvin Slosman

We've and Yes, Ben. process the I regulatory moved the so, part engineering pathway. phase development of we're and now through and on the to V&V think

So before Assuming relative regulatory which but phase, track things about there, has our certainly I seems be pretty remain on now spoken variability. timing think into what some consistent, to to we're approval we've the

Benjamin Haynor

patients maybe than sense. enrolled? it's remain the be seems makes might on a like more percentage for I it And expect congrats. expected. sites? And if of know those many XX in Sure. CREST-X, that's Do CAS you arm That have lastly me, then sites, how might you to decent XX

Marvin Slosman

a number a look good arm the firm know we the overall. available, don't I Ben. process on options. the behind patient It's Yes. enrollment to stenting forward of a bit We question, is the like other making have CGuard beginning But also in taken the And then C-Guardians you those said, to those There easiest trial. XX CREST-X weren't to with that enrollers, in sites. C-Guardians We and sites path actually started CREST-X follow. well. back were converted actually some participants we've as

of good So both have CGuard a opportunity it's been to to a discussion on patients. options available those for

Benjamin Haynor

for I think questions and on the had. that's progress. taking all all the congrats I and Thanks the update

Marvin Slosman

appreciate Thanks, the Ben. coverage. We

Operator

turn Slosman Marvin the for would This closing to like any conference concludes session. I the question-and-answer over to remarks. back

Marvin Slosman

everyone and Thank support. call for today operator. thank like you, I'd taking to your the ongoing

continued the this and are our progress. We year of half November next of quarter quarterly first extremely update the and from proud through progress forward and to the look in the

Operator

today's conference concludes This call.

Thank You and a participating, have may for disconnect you pleasant your day. lines.

InspireMD (NSPR) 9 Aug 222022 Q2 Earnings call transcript