NSPR - Earnings call 3 2023

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Operator

Good morning, and welcome to the InspireMD Third Quarter of 2023 Earnings Call. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that this conference is being recorded.

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

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

information only publicly update This required to disclaims after to obligation contains this XXXX. that as any circumstances by revise law, call. is any as or X, November time-sensitive reflect or information Except call occur today, InspireMD of that events accurate

to It to the is Marvin ahead, turn now go Slosman, call my Please over CEO. pleasure Marvin.

Marvin Slosman

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

market both validating procedural proved focus of tools, superior be a our further mission physicians broadest quarter patients strategy range our our along carotid with and optimal milestones, a implant to several and revascularization third transform company the The transformational time providing next-generation solutions. with for on with to stent the

CAS brief decision of start neither to focus, expanding include standard patients, enabling but monumental by risk the for shift stenting today remains surgical both recent objectives with would previously I internal or covered. asymptomatic coverage artery our like carotid which against reimbursement and a of procedures by CMS, were national to mention a Execution

shortly. into those will details get We

of over revenue quarter metric to procedural revenue the on our in sold, X% Measuring period terms $X.XXX million as success discounts price comparable in of devices market for XXXX, a X,XXX transfer sales growth of a our pricing. more total the be we continues a In our third financials distributor our volume our XXXX. our measures accurately generated key nearly Unit average of representing way served growth share key model of by driver objectives. territories, sales of

in the data XX,XXX from Stent drive focus, nearly date were C-Guardians patients we remain baseline utilization and expansion sold CGuard performance than As having a the established global of awareness, at with trial in cornerstone more in X,XXX the our days VIVA world-class conference. and market enrolled experience our clinical to plant XX-day now a present to data of pleased clinical few IDE will studies. ago real-world We

designed trial XXXX. CGuard a of the which As year, line a support next of to in of in the approval PMA of the C-Guardians would first us to reminder, possible submission half sight U.S. half in is the EPS second give

analysis measured in X.XX% C-Guardians the of be of date collateral enrolled myocardial rigorous all-cause system. data and stent DSMI adverse results. are XX considered of Metzger, Committee. Reviewing death, the carotid sites XX CAS primary performed XX adverse Events prospectively intent-to-treat by as through from mortality, All stroke events, to at or XX trial Clinical measure total study to by single-arm is the CGuard The PI XXX. adjudicated and the patients day utilizing Dr. U.S. or a the endpoint at if days, from of including unprecedented crowded presented procedure any the through the XXXX major stenting post-index XXXX, July XXX artery days, Europe, most June results Chris events infarction of events, major as a composite EPS were or in incidence stroke

significant to outcomes of results add as the alternative body practitioners to compelling effect pleased stent way of Stent a is and at compared and current results VIVA and important to CGuard community, showing delivers in patient opinion demonstrate most of were first-in-kind the which CGuard the alike. share endarterectomy. key and raising gatherings vascular of neuroprotective These of specialists care should revascularization growing standard short- long-term CGuard carotid end evidence end outstanding the of and that go and awareness the among of the leaders among these long the vascular other toward We

Revisiting announced that our with was XXXX. National planned primary topic in of of standard follow-up and Stent We trial performed and June expectation key study cases whether just also recall patients, new risk anticipated first human surgery. On approval in achieved symptomatic this delivery drivers that implementing IDE a our CAS our of first Determination, had for XX, results as considered on half this moment. a year with we And we enrollment endpoint includes CGuard XX Study towards NCD, the in or Staying Prime that is issued of completed of asymptomatic market transforming high progressing for coverage both the the something next trial, CMS revascularization system. reiterated months. half for Coverage second the the to or for one in be stenting. of October cash

We for both of with market CGuard good options, CGuard clinical procedural an our standard believe and of expansion our that demonstrated to ] EPS with to the date, patients results. sales updated broader is addressable toward This Prime part nearly market establishing performed and who the stenting. procedures for The clinical consistent TCAR, U.S. determination and cash, shift greater approach creates patient-first will that options meaningful strategy. draft a long-term the for very for rigorous best-in-class thousands of published NCD coverage in studied outstanding memo CAS foundation This adds of peer-reviewed in released to journals of now care integral that of X,XXX including results both was endovascular were are July. a real-world has trials, the of for opportunity tens a [ access very Recall which patients. in enthusiasm is in

amongst story, The leveraging were some stent approval support U.S., continue activities leadership our third-generation the of as of we Medical month, time. for the CGuard hiring Executive we vascular Stent of of to of I Last CGuard pre-commercial announced remains surgery first of tremendous the world-class Clinical new and stone over the to potential a in opinion be VP build and Patrick of proprietary the driver which Patrick team. for experience XX Verta outcomes its he half implant, shift an supported field away years, initiated Affairs. with its has much bodies. regulatory having of out our impeccable medical carotid mesh. The we in consistent what the reputation approach first clinical anticipation and brings performance our last In in consider XXXX, have we've MicroNet leaders, Dr. from key advancement the advocated and

promoted VP significant announced as commercial our level. expanding Tal North responsibilities Officer, capability support function of also after our a to global his to been to General impact the Chief Cheryl in Gleason and has growth. having Global America and Commercial of our Marketing, hiring business a Shane assurance on affairs of We lead Manager global of And quality finally, building scale X expertise months with and tremendous regulatory

to to testament best a truly our call our Craig? behalf our to preventing commitments word as difficult without close is based remarkable Shore worldwide. pleased to It such re-welcome team devices would profoundly Craig bravery patients now their on I'm during a company mission to with deliver I Israel a tenacity to operate CFO. to the our objectives back allowing for like on time. team, strike interruption our of and and fulfilling the life-saving in deliver and to

Scott Gordon

Marvin. Thanks,

of completed XX, CGuard in patients $XX,XXX trial. IDE XXXX, to For ended a States million there revenue the our was offset predominantly a XX, ended we the ] September increase have our months X in of sales X $X,XXX $XXX,XXX EPS existing in in $XXX,XXX geographies And as by June enrollments September This further was XXXX. and to no of X by compared CGuard XXXX, during the increase months commercial million September in decrease XX, was months XXXX. enrollment driven the accordingly, United an [ the ended clinical $X,XXX revenue

months the same XX, during from the XXXX, in For period ended to XX.X% September gross $XXX,XXX X $XXX,XXX profit increased XXXX. by

X third This an Gross gross September resulted increase $XX,XXX the material the miscellaneous September to the in to $X.X driven XX.X% during of factors million during in million, X quarter third XXXX, ended increase expenses by related XX% an compensation predominantly associated compared $X,XXX for ended XX, months to XX.X% due operating the just from the profit increase offset was XXXX, revenues months XX, mentioned. of and the margin increased less This $X.XX in XXXX. or XXXX of from Total for expenses. or million expenses. increase labor, by increase an quarter

deposits. or financial XXXX diluted increase the quarter the and and the a share interest a market for $XX,XXX to net money quarter XXXX. third of period for compared quarter $X.XX third million share of marketable basic of in $X,XXX was totaled XXX% the or XXXX bank $XXX,XXX per primarily of was income This an $XXX,XXX Net Total loss XXXX. for million basic of funds $XXX,XXX $X.XX loss and income due per securities, third short-term for compared in to or to increase from diluted increase $X,XXX same investment

That were cash as XX, September and XXXX. short-term investments equivalents deposits $XX.X concludes XXXX, compared $XX of As bank XX, prepared our remarks. of and million December to cash, million

the now call for questions. Operator? will open We

Operator

Ladies session. sir. be and now [Operator you, the gentlemen, and Thank Instructions] question will we answer conducting

from question Sandler. of go first Please ahead. comes Piper Our Adam Meader

Adam Maeder

progress. kind Congrats And little data you print a to opportunity QX follow-ups. more. then the flesh about give messages quarter? just trends last on I and of talk performance the start, of operating a week, kind you the in just wanted the excellent to I presentation to key bit handful had of the the out interim the Maybe Can

Marvin Slosman

the for thanks Adam, question.

be continues And commercial to outcomes and continues drive by in our of be the So think clinical of which to way data. growth is outside I progress performance message the strong. U.S. to consistent,

and Our are comfortable becoming more with distributors, CGuard. more I think,

more And called recognizing them to all that residual and of In we're fact, also I think we other our engaging had U.S. momentum is the benefits the just the a day markets full is paying in U.S. distributor the them. what's happening building with outside in

consistency continue to So this those markets at and growth, terms we'll numbers foundation point. revenue of of our and in as that we're in real seeing drive there

Adam Maeder

just war. That's around initiatives team safe. helpful is Can kind ability staying members I Israel-Hamas all And thoughts are about to question question multipart you your hope color. the on of a My talk of next your U.S. any in Do kind market? efficient this then of impact the along anticipate to future as manner? forward you And supply an any guess in any or one sales well. hindrances the I commercial push to

Just or alternative you inventory or efforts? taking steps precautions any proactive -- are with management manufacturing

Marvin Slosman

and direct not question, on far, keeping we're to perform alternative but goods locations of for into supply of the sitting not a for mitigating by examples impact we've Adam. the Thanks Yes. some had things things our eye Obviously, practices good put by deliver inventory, the Thus other our and very war. -- place And have any chain, securing way still. ability of circumstances. there finished we're on just close way at advancing -- building and that put are under risk looking

according a to as much term, short operating the all well. plan our team is toward of shift focus U.S. But continues there. pretty in Our

of couple everybody active work have from folks extra is reserve. We a gone be have up But done. the to picking that duty to

terms relates of consultants plan. of our outside testing of Israel activities We're U.S. on and are and and based toward kinds it those work approval. to things. changes all there. of progress our our effort regulatory Many In as Nothing actually and

and most that as think at sure ground and there. to a if to we're there, make sound, good see making chain that good different results I sure right our but critical are we're this So on direction continuing that is remains supply looking now well also into production progresses

Adam Maeder

standpoint? to about outlook. over Marvin. if a of thinking I for broad kind but great the hear, certainly QX fulsome strokes line color Maybe or have give was recognize any business don't That's you're as guidance, top to the from there. XXXX can Thank you as response switching in the forward you well about you wondering how

Marvin Slosman

Yes.

transfemoral we countries CGuard So to I in offer Prime sets, until TCAR able to on CAS to we're the this working we frame growth our want to countries to at is point think new consistent that growth the area that effectively in continue say our new and which direction obviously, those system. operate way in We the tool XX serve. delivery we're of aggressively see

to point. market. to we've a at presented will obviously, up according different believe this how very we new things to what tools we But dimension those can the think I consistent penetrate remain

is stent performance and it to that of convert which U.S. in U.S., Our surgeries is different first vascular will objective the outside using U.S. the our end the of to as to be no outside same is do that, by the the

So There's being a being there's practiced. still done. lot endarterectomy of a of surgeries lot

And not is to in the most continue so just goal have stent market, to premier convert to but our importantly, surgeries. the

to So remain And show growth that plan continue consistent. consistency our well. there will think as is I to

Adam Maeder

this any the point? you If could just push internationally? a know little I Prime able have commercially was thoughts helpful. That's Mark an when kind Marvin, I unpredictable, give CGuard a European little those bit maybe and there, latest to of the MDR and is Obviously, Are to available approval. but at bit TCAR update CE you

Marvin Slosman

Yes.

as the longest new in think, this get process serving that cycles. We're the somewhat MDR now. we're good launch a and will But in environment the which mid-year hopefully I certainly countries pole here, waiting to XX in that tools XXXX said, regulatory frustrating. regulatory be has tent are general able through the whole position been you for to anticipating in be prepared, the ability the remains just but into I'm the to Europe

Adam Maeder

you we U.S. in -- improvement there? we you Nice QX spend start to wanted and This P&L hear for Wanted one can do margin, to you think Craig then you. you forward in about similar to And I and welcome 'XX launch? outlook the Craig, as to about continue year-over-year gross helpful. from ask terms the a of back. That's do 'XX drive of for question. growth prepare how guys of think kind components, ask OpEx as to pace

Jeremy Feffer

Okay.

on more anticipating thanks, start focusing the the wouldn't spent to amount money [ to welcoming until there, talk sales higher I talked Europe. of a as we few be get a a States marketing for bit as also and activities I that be Adam, launch. positions studies back. start huge United of the quarter, So spend TCAR, particular me in expecting but we here ] in and mean major. in we for little more we To the about, closer nothing the fourth doing and a

Adam Maeder

first that's on of some early think to into study, my pointed is I the work clinical for a Tandem start then doing 'XX And clinical pivotal. the And which good the Okay. still last I also Any there? segue study, targeting early of 'XX think you're TCAR a timing the are date. more question, work? feasibility that outside you specifics The on design? What's Lesion U.S. half for you trial latest or

Marvin Slosman

start let's Yes, yes. the Adam. with Thanks, --

the with start Let's last one first.

area. half still of in EFS progress are first that Tandem to in the for XXXX continue and that enrollment We anticipating for

conversations well X a the FDA both have for on gone as well. our as pre-sub basis EFS, separate TCAR had very conversations note, we've which to study -- the Tandem Just with

the So we're details, now the procedural midst to protocols, this all investigators enrollment. aligning process of of buttoning of the just in up right begin the

think And first assume half so those both them it's of safe that we'll studies XXXX. I the in of to initiate

to details. get all we As those

roll-in setup there. there's to know, a you goes lot get that the into effort the of and administrative As started

remarkable by looking that our community cash will neuro from response system. community forward for We the focus, and what those on we've foundational has the within our both TCAR system mention community. tool to But as is both been EFS well the carotid we're our on having had to surgical both I neuro that set added as think underserved a fronts, the

Operator

Haynor question The of next Partners. Alliance from comes Global Ben

Benjamin Haynor

expansion taxes congrats off y? regarding are numbers? coverage patient guess, on x now First terms for that, x addressable me, it's What was what's the I the population plus your national determination. But of lives? If on those view the and and in

Marvin Slosman

question, Ben. Thanks. Yes. Great

stenting in sets procedures in first. carotid that those CAS be vascular What which I both amount first is about a market end this tool over think very XX% What plays of surgery that next that terms invested XX% to versus what are a to from we that there XX% How behind that is order the we by range is of out determined, or surgery let's years is is is within certainly to right? still revascularization. first, the call of tremendous be several know or think we a We shift why that broadest in of know to it, options, percent TCAR some give us energy determined. both decision CMS. the of viable a is XX%

of default It's opposed surgery conferences, baseline. is discussion assuming sort interesting to stentable endarterectomy some that never which just as that becoming -- the or at you've of before a heard the now lesion, is the being the

really us, to set coverage CMS the the market is we've tool got opportunity for the to is full make best So that which implant. regardless and fits coverage think access sure strategy, up perfectly our I opens which for the used of of

I be we're timing feel The good is shape of think to transition. there and question about in So and the determined. percentage still good

Benjamin Haynor

the just anything the obviously, there? conferences, the additional color going then see at at VIVA. that -- that That's surprising any a you maybe Or sensible you that's on thought off? helpful. things Any Okay. discussions -- And there? these lesion where discussion surprises mentioned on hadn't is And regarding just

Marvin Slosman

unprecedented. we is Well, being XX nature I think just let's a to even unprecedented deliver, presented. most the about really that complication think able days, in of surprising rate results remarkable the been mean what's is sub-X% I

seen standard It's platform question outcomes. a frankly think of is unique that been these goes stents beyond in care. terms of really become a has it of never this before I So will just

mention previous this also at will in I values X,XXX patients the we've rate. X.X% studied that Now experience about our

lot because just be what's it's result like So transition, the in and being talking and able decision opportunities but it's momentum being more will best those we and There how and do the really -- from procedural outcomes clinical for I procedure. that's I CAS listen, in and itself ultimately, discussion, think in and think combination to implant be But of not a trend, to points by patient be that right? best that momentum position TCAR. way the best the about the in of lead a more a implant will translate outcomes going outcomes

Operator

and question-and-answer Ladies our have you. reached to Slosman now Thank end gentlemen, hand over of Marvin we closing the I session. remarks. Mr. will for

Marvin Slosman

to I for forward XXXX would our execution in plans like call beyond. everyone the finish XXXX for joining and We growth look a to toward and thank strong great today. advancing of

Operator

Ladies you, today's and you for you gentlemen, sir. event. lines. that Thank and concludes disconnect now Thank your attending, may

InspireMD (NSPR) 6 Nov 232023 Q3 Earnings call transcript