NSPR - Earnings call transcript Q3 2024

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Operator

Good day, everyone, and welcome to the InspireMD Third Quarter 2024 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank you.

You may begin.

Charles Padala

good and operator, you, morning, everyone. Thank for Financial Results you joining Call. us Quarter Third InspireMD the and for Thank Corporate Conference Update

Joining Financial are and InspireMD be available Commercial us Chief also today Officer; Q&A. Executive Officer, Marvin will Craig Shane Officer. Slosman, Chief for Gleason, Chief Shore, from

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

Form For accompanies made Securities reports and refer filed press most XX-Q to updates U.S. more in in on please release InspireMD's with that reports InspireMD's the particularly in these cautionary recently it. described information call, risks, the filed Form risk and on X-K for Exchange our about statements any corporate and the factors periodic this Commission XX-K Form

This ahead. disclaims that call go Except It law, events information circumstances that by reflect as this only after Officer. pleasure publicly required as XX, over accurate please InspireMD today, Marvin, to is November Marvin is call Slosman, obligation or of now to revise XXXX. to or update turn any contains call. my to occur any time-sensitive information the Chief Executive

Marvin Slosman

year. than like to results. a XX% more CGuard quarter thanks and financial Chuck, million, of total representing with to everyone morning. for last begin third you, the revenue growth I'd call of Thank strong reported of the our joining review over We QX very of $X.XX this

date. XX% suffering XX,XXX in during consistent year over patients of Our commercial which thousands our to representing solidify of proud more results implants benefit from period foundation last implants with than these by same growth growth We're the particularly CGuard were the quarter-over-quarter of disease. strong carotid over of driven quarter, to the X,XXX demonstrate sales of sold markets artery and end results, our nearly

across have patients double-digit stent captured our Our stent outcomes. we best-in-class share has providers now and market clinical leading countries XX where with technology to benefit carotid from enabled

in equal and As We and we over how would of we to have once of the sold in the have again which revenue. CGuard would sales market in markets TCAR anticipate the XXXX, implants Prime approach units U.S., potential offer in half U.S., If U.S. X,XXX $XX a first at international instead to generated in we launch QX the sales of our approval current CAS during would mix the these translated like of global assuming an U.S. million quarter. revenue, sold measure ASPs.

in perspective, procedures revenue million put quarter. the X,XXX further global about To our on sales TCAR reported in current $XX leader market volume U.S. last

our patients market in TCAR So the we already are as U.S. devices patients the the reaching have of global market and even terms entered nearly of not half treated, yet. number leader,

positions our U.S. believe future procedures into our SwitchGuard cleared. business continue for System for revenue the We Neuroprotection significant market, of once introduction the along our growth to that entry TCAR with

once we carotid and sales standard we the margins new intention CAS in versions while growth a will As to XXXX, to approved. in in drive look market continue in significant both U.S. TCAR and both establishing with investing revascularization

premarket with during agency. submission staying to third review facilitate results from evaluated And and to The device the primary sites submission efficacy our trial of XXX the data C-Guardians disease While safety we complete, application, treatment Interventional Prime a of is based overwhelmingly U.S. event the Course months regulatory Leipzig CGuard which of of forward X-year that submission patients of adverse we a decision, modular of U.S. the the the such prevention. Recall timely clinical our FDA. and market the major at artery stent rate through procedure, trial topic showed this stroke year. opportunity, an date. our approval the by carotid and artery the across our or in Europe. C-Guardians post treatment was to the We PMA, for now carotid of XX quarter, reported enable earlier positive rate lowest trial embolic on submitted enrolled which, approach event efficient carotid The look utilized endpoint a CGuard X.XX% XX the our would on positive, and U.S. launch a for stenosis clinical presented protection for the any to if

FDA the accepted launch period. then our XXXX, submission decision review approved. we plan, a are to triggered from prepared Therefore, on anticipate operational and we a September notification received which XXX-day execute a early PMA aggressively effective if was We robust in that XX, commercial and

X As $XX.X XXXX. this proceeds an a would tranche, private in the transformational trigger tranche up to FDA placement million July upon million positive we reminder, pursuant receipt past that tranches If the C-Guardians additional exercised, second approval for the the of milestone-based the would the triggered announced financing the $XXX.X of premarket next gross fully first company, pivotal from to in raise presentation May of second data. year of which, like

which include including sales remaining which States, commercial of Soleus, support regarded and show for CGuard members their are premarket additional grateful our financings company After of institutional of share to in of operational half as OrbiMed, Today, support the I'm approval, what pending the pleased as Wace, completion SwitchGuard trigger pending a earlier tranche who XXXX, mentioned of quarters our milestones, submission our to build based consider Velan X very vision, Board which CGuard of the investors be and include ideally U.S. back the today. our from in highly we in that anticipate stent, well United Prime. our of PMA, world-class of Directors. I seamless positions commercial Rosalind, FDA continue Marshall strengthened receipt plans. In to commercialization X We to to new our CGuard we clearance to reporting the current the to with launch. I for would TCAR us Prime executing kit facility the a and modular especially we of a approvals on continued headquarters our new anticipated parallel the and support to our Miami, world-class we've transition are out positioning and Florida, by engine have to launch U.S. Nantahala, facility This

and a and strong all supporting which has sales, infrastructure, teams field provides Florida device the ongoing of medical rich top-tier resources support operational are support access established, that of our to build in therefore, South other demand us talent continue for build-out and history of innovation while base clinical are outside to now fully and we ongoing. With the approval, U.S. prepared Prime CGuard to SwitchGuard anticipate serving success System. the U.S. on upon Neuroprotection we U.S. contingent our

pipeline. Prime. stent Turning device the developed procedures. TCAR Prime This a FDA and our the we that announced system, pivotal our use significant now for the study during application including Last tool complete offering next-generation our exemption specifically TCAR-indicated step for represents initiate to enhancements, to approved month, CGuard carotid TCAR investigational an with CGuardians implant forward X of set CGuard best-performing toward a

the will next debris Prime. circuit during to platform procedure. accessories, it prevent loss and and vascular provide minimize a top blood closed the carotid traveling and an to designed a CGuard during which As features embolic support the blood stenting the set next-generation returning cleared, a filter combined SwitchGuard reminder, is through generated we've With procedures, neuroprotection brain, the TCAR in best level patient input a from to procedure TCAR once integrated to passing surgeons from and implant tool world's developed TCAR performing performance with TCAR of carotid the

procedural and was physician our and base and intended to tides TCAR toward an ongoing a both further reimbursement the endovascular time standard shifted carotid was products when said done we've performing programs of broadest address in As innovation first before, product care. anticipating revascularization CAS investment the and

an acute Neurosurgery, stroke Prime tandem Siddiqui, severe thrombectomy to lesions. now study State Professor with into announced to previously of of strategic growth feasibility We the and market and Jacobs of stenosis Dr. Adnan carotid early ischemic agreement in Chairman a at conjunction with Vice and Turning in of our with York Institute we that conduct New presenting the Buffalo University or occlusion initiatives. entered for CGuard patients

CGuard carotid artery Prime the proprietary prevention MicroNet procedure, feasibility we As of stenting in procedures. with a its is reminder, mesh this during embolic superior study designed stent using believe these provide safety stroke and and to acute our demonstrate will

Craig? and call strong to At the enrolled anticipate commitment Craig patient in neuro our community this to to review financials. to a of the reflects the strategy. turn We Our long-term critical this imminently. like will be growth over first that component represents the I'd our point, investment study

Jeremy Feffer

Marvin. Thanks,

September or the X in year. to from new during the period existing same increased growth XX.X% markets. For $X,XXX,XXX by by revenue months XXXX, increase This ended $XXX,XXX and last $X,XXX,XXX was driven XX,

primarily or to X the $XXX,XXX during of compensation, ended margin by to interest third resulted ended quarter profit the gross of financial from money short-term was the expense. million months XX.X% due $XXX,XXX million XXXX. for loss and or and The from for income $X.XX primarily decreased period in XXXX $XX,XXX to for by $XXX,XXX increase gross $XXX,XXX of decreased XX.X% in were the diluted market for the quarter income the September XX, an period to XX.X% diluted the an $X.X quarter increase quarter $X.XX in $X.X the from for profit from XXXX of I XXXX by investments million, or in of or decrease third third compared third securities, an $X.X same increase the from just months period This during million increase last in in development per XXXX, to driven $X.X year. year, $XX,XXX XX.X% expenses. Financial miscellaneous was increase last or basic the increase the deposits. resulted in same expenses third mentioned. Total net $XXX,XXX, bank share income XXXX, quarter $X.X marketable X.X%, operating increase This an clinical and XX, X share a totaled XXXX. Net compared September million and of For per of XXXX. of same compared funds during loss a basic factors Gross for

as our of to were This million XX, XXXX, of As marketable remarks. December XXXX. million September concludes cash, cash compared prepared equivalents XX, securities $XX and $XX.X

for We Operator? will now the call questions. open

Operator

with [Operator question from We'll first take Sandler. Adam Instructions] our Maeder Piper

Adam Maeder

ask about nice ready going? here to Maybe market Remind kind U.S. ask on able in that activities around product, us of update to the also get fully for confidence you're transition that that the U.S. to level hiring. targeted the force kind ability the get quarter would I launch. then headcount supply start, U.S. And Miami about standpoint, and specifically I to to thinking for in there? headquarters a supply couple progress. be the of the from you'll specifically the to launch and wanted how and follow-ups. running. then, you're ground we kind an And about some sales doing hit of Can is of Congrats commercial a I How new of manufacture of had of just

Marvin Slosman

Great. Adam. hear to Thanks, Good from you.

the last home with by as our of So to way, been and base of And in We're thrilled talent operate Miami a great and where the have a together in by question the new part the we've talent. interest can let we the company of first. amount overwhelmed, be gather to our company. facility. me level It's the unified start

thrilled of operation we're to base really here. So have

In ability through place have to strategy. into X it other operate right Aviv the meet our and the Tel demands, on we're supply own strategies one our then to a And facility. obviously we're that putting and our contract approach manufacturing continuing we now, of terms from build

making So we're a demand going these the is what making we're requirements supply significant into plans from net significant think and we the believe to market. result meet from I that investment be that will sure

grown our So we've with we're simultaneously growth. flat-footed kind our of the operating pace that continue Again, got X to business working market here. significantly to stool years. over keep we're not all legs of We've that

talk good So we've in team to formula feel a we're and that can we the bit room onboarding the got approach of. we me. a got how currently. him Shane Why commercial with advantage I've let the don't like here take I

Shane Gleason

morning, Adam. Thanks, Marvin. Good Yes.

the So in we've a of year. approval been half first as next know, launch you predicting and CAS

year the So to and our starting on been team start field put the commercial plan this next to the literally early game year. build has leadership team then

in hired. the our And So really attracted. have over the we're roles here in X X of business are I've cardiovascular level XX interested a we executives that there. best well have the on and of I'll been lot say, way people in those some space that in roles years, been thrilled just various first commercial senior I and with I'm for

track So roles I'd about fulfilling that as say we post them. and we the we are on have those enthusiasm excited other

Adam Maeder

one or mind? focus of more on there physician Do cardiologists specialty. That's to The and guess question of your Is be throw And interventional that. Shane targeting number a accounts then next accounts question in year? surgeons one follow-up wanted commercial the question I of a is out Which I'm the U.S. good you around that Marvin initially vascular -- have guys. do on strategy. to commercial you And next for kind certain trying color. you initially? of think that for and kind specifically have Thanks to the I way through strategy it's you I plan would gate more the

Shane Gleason

Yes.

So we're go for first are performed, and those approval taking procedures interventional be with the that's interventionalists. neuro to CAS, to is and being likely to cardiologists going going be our specialty going piece, the where and most

our be to spent. So time we most expect that's where of

more the primarily know, with into But the on, stenting get we're enrolling think those get surgery be the approved TCAR the world study. products. pickup for I a will who TCAR you community broadly, it As which from we when our doing be enthusiasm more will And vascular and are to early carotid interventionalists. be procedures, more going we'll

performed. where We're data. contact close have being We know procedures the the here. are with in We leaders thought claims

Our the to think, as without made use as to I excited trial product available are it's sites, commercially. exception, soon them

idea using gaining among this is our and be make sure product of know this parts job. one focus So really an the are we'll to of physicians enthusiasm and terms in the product. targeting, physician that we that targeting, be in that I've to repeated have thing we'll The going using easier is interested

our navigating to make early them. available So can approvals a committees of product be getting and lot those product we on efforts so that will the

Marvin Slosman

energy a procedures Yes, just on there also add our in focus picked my We done neuro study. the community, currently of Adam, that neuro lot But invested broadly, a setting. in in community, community the specific and without stenting, early currently think label. on is up lot focusing why of think know many we're is let that Tandem they're me understanding that in we That's also the is comments of specifically. we CAS you part more a being that feasibility also, optimally that attention that and CGuard cases, suited I transfemoral in

So initial be that's Shane in the investment with the gate, said, as of out transfemoral our side. continued related focus will anything TCAR

Adam Maeder

a Makes there, into sense. you for And for last segue initiative TCAR the good Yes. guys. the just ongoing. me, that have Good one color

and just trial the I'd differentiation guys bit curious design, and to to and are I'll try of IDE So marketplace. And study, be bring about you C-Guardians enrollment approval? a in terms the little features potential and the there to us then that that in you back X, pace what also queue. can about SwitchGuard tell leave of the potential product it the hop trying more learn

Shane Gleason

I'll Okay. going there, Adam. keep

C-Guardians IDE clinicaltrials.gov. So approved. X, been that posted It's is on

tailored system X planning NPS Prime is TCAR CGuard there. what have there in a procedure with is short a available TCAR So for we X-step C-Guardians commercially approach. using out delivery the the we're really that's the

-- step same CGuard that C-Guardians will the Prime X next with SwitchGuard stent Our be is that NPS.

a in to get SwitchGuard second. I'll So

NPS. patients XX available the So CGuardians X, it's with commercially

So SwitchGuard, before We're we to We have through first Move sites be and X, year. don't -- to deliverability system. think there working we of have but with on and ready about we're on the end talk we efforts features specific the CGuardian our this there. -- all enrollments of it, the now, to expect I focused contracts of really, focused access the usability,

has deliverability late study returns on there And our at what's I think leading I are hit I participating. had say preclinical that versus we something surgeons and where mark So vascular currently was that we've summer, usability, that can available. making GLP advantages the X early this

Marvin Slosman

our they'd lot great we what to feature a with these performed to like only the like and set of efficient of it TCAR been that able to feedback have relates to level as I'd effective. being strategy, advantage procedures customers over XXX,XXX SwitchGuard more in and to how from improve that, our add make as mover assess the we second that to having can procedures experience

so that really sets to And we've program. taken launch our heart and into feature those information designed

one next just our me-too will out plan but that be So a to at is really not come product, with performs level. that

Operator

[Operator questions turn this at closing call for back time. further we comments. no I And show the Marvin Instructions] will to

Marvin Slosman

you carotid pleased joining like Great. ongoing and to launch our today very to everyone support the revascularization progress, of forward of this the call very novel for with the with U.S. and our Thank CGuard for and thank Thank much. mission I'd we We're technology. to look year. approval the next lead market you.

Operator

you. program. participation. your today's this conclude Thank Thank And for you does

time. may disconnect any You at

InspireMD (NSPR) 12 Nov 242024 Q3 Earnings call transcript