NSPR - Earnings call 4 2023

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Operator

Greetings. Welcome to InspireMD Fourth Quarter and Full Year 2023 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Please proceed.

Chuck Padala

Thank you, operator, and good morning, everyone. us financial InspireMD conference results joining full quarter call. for XXXX year and you for fourth the and Thank corporate update

CFO, Joining Marvin InspireMD from Craig and us Shore. are today Slosman; CEO,

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

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

Marvin Slosman

company. share our tremendously fourth for quarter, productive Thank you, remarkable Chuck, morning. I'm to and thanks to XXXX everyone a this pleased completing for joining the to call end a

looking focus the view half growth the reporting with in continued XX-plus this we of best-in-class revascularization primary as our OUS commercialization We approval forward our have market carried this half as served lead our the first platform, of the first the results in into States from and X-year year our to well carotid year markets. a on United potential XXXX and in energy trial carotid to stent C-Guardians endpoint CGuard continue new enthusiasm mission to the as with in

quarter $XXX,XXX. from impacted XXXX our by CE work care. and market of and standard methods carotid toward market of endovascular CGuard CAS superior review quarter to growth and and evidence the inertia these at investment a million, was MDR, or basis, and impacted we on purposeful anticipating build gold outcomes Our tools, of the make fourth reimbursement of that of on our our generated year building patient sales the stents, focus TCAR record advancing year-over-year XX,XXX our done real-world stents, potential innovation create an with that the new sales We Mark We broadest U.S. tides standard compared XXXX to as addressing a markets of a we to both awareness to X,XXX in a sold of I sales market plan continue up penetration to global to more growing year-over-year, as to implants share the our fourth $X.XX our or post the XX.X% XX% globally. We our that outcomes procedural suspension of technology medical this regulation, we to device representing experience. lead growing Medical move building and sea growth XX%, surgery CE more date the when reflecting Even performance. sales it regulators best-in-class than but than body commercial the of an time CGuard as on temporary to fourth cover will real-world time of of we believe our of our what potential. We data generated shift catalyzing the XXXX the our from away change indicated adjusted MDD, approximately with last by framework. quarter November Directive, temporary circumstances, brief to approval. Craig leadership be marked from towards financials considering CGuard as Device our quarter in transitioned shortly, wanted European fourth the were revenue total of Recall XXXX. beginning OUS expiration negatively Mark

development the CE The Mark in approach patient, our required changes broadly, from rest and and Another us granted, focus. and these was MDR in product under formal while addressing derisked with our our countries, the be recertification our device in continue MDD medical timelines U.S. topic markets our European OUS and significant this provided increased from enabling during our our MDR regulators removed notification to requirements, in this lengthy under priorities we ability transition like continue under challenging now the to as uncertainty EU-certified highlight of of and MDR. we've to was process. persistent in the invest pipeline to sell With MDR recertification to comprehensive to parallel industry

Vascular and Ohio; designed November Chief and in trial, at Turning XX-day Health Chris of at at is last Ohio VEITHsymposium, place the C-Guardians both our trial CGuard which to in Columbus, C-Guardians, took support data of principal year. the pivotal trial of to presented XX U.S. Dr. VIVA U.S. IDE then follow-up approval System the Prime in Metzger, investigator from of which

single-arm day index major As events, patients the including CGuard the carotid Europe, to our all cars post at through XX DSMI post XXX prospectively in and stroke an system, any stroke the procedure. Between procedure or a important in XX reminder of sites stent were primary July CGaurd XXXX which incidence included infarction, and of the U.S. or Prime. XXX study from XXXX, results, enrolled performed trial including also day is next-generation composite June the of mortality, a adverse ipsilateral days of XX endpoint myocardial death,

of MicroNet X.XX% mesh innovative with and XX-day stenosis our of carotid lowest unique of the pivotal treated continues with follow-up. our our or neuro reporting MACE acknowledgment to With application, carotid to in results data remain had through the PMA, in of on presented third XX-day track in primary endpoint with were CGuard, endarterectomy, the experience. validate rate any procedure to CGuard the anticipated timelines, DSMI CGuard, data of with of these Patients half in FDA, at approval These results real-world guidance. first the for we remain [Indiscernible] anticipate our a carotid best-in-class risk submission qualities this This consistent XXXX. the prior midyear, year. XX-day rate premarket of XX-month in consistent possible date. We high trial on from quarter utilizing the by followed report artery timelines United protective Based it's States of

continues and our to II for advance devices study our now look major intention as we to CGuard shaft product SwitchGuard with short enhancements. procedures tool of Turning accessory with TCAR next-generation our our programs. clinical clinical along neuroprotection and system, C-Guardians set development with TCAR

just Cincinnati, a University PA adviser Surgery Cardiovascular traveling carotid insight few the the As at of to is CAS, Health carotid and blood and blood Dr. brain, designed and Missouri; to in TCAR act loss initiatives. the a and as prevent in at an Patrick act close of integrated of St. for Philadelphia, Jefferson We that established II, and Hospital both School to and Chief and debris weeks bring already in field to extensive build a providing Good Professor Professor of Systems knowledge, Gray, enthusiastically at very passing William during lead of Chief to to and in and Dr. Dr. and benefit University the minimize our to PIs ago company. announce wealth in interventions Dr. reminder, Louis, an to Geraghty, Mainline of were Vascular Geraghty, our Medicine experience Surgery through be a we SwitchGuard Samaritan thought are fortunate guidance filter embolic we Washington the Thomas Ohio, patient multi-specialty Division Wynnewood, Pat as returning of Together, the pleased agreed us will Muck and to in leadership circuit of They procedure then an direction NPS procedure. objectives and as able knowledge from it and from group strategy. at these that their C-Guardians the are leaders stenting join Radiology during Muck, Director to Gray generated

the in these with carotid expanded we their Also market at or provide MicroNet both with to State with are meet to designed tandem comprehensive its U.S., opportunity the is lesions. and individual unique to CGuard these demonstrate availability Prime Dr. in procedures. broader the reimbursement. treatment mesh now of feasibility for as We less early occlusion tremendous in This Institute in offering plans or is ischemic we of Medicare strategy, a proprietary or feasibility CAS options October, believe during fourth is artery changes high coverage for of In this agreement our CGuard and CGuard stenting. of of expansion carotid York these patients. TCAR Centers patients by validates Chair conjunction approach. reimbursements that which CMS in whether be lead timing provide quarter, to stroke to superior potential to TCAR, with with standard New will study for stenosis and Vice at risk and a our to The announced Adnan for or University Professor patients approval the carotid and prevention Jacobs to stent the and presenting include via of during of and of using will safety embolic enable and us Buffalo thrombectomy to The solutions. implanted the Neurosurgery of study acute and CMS our Siddiqui, coverage agnostic Services invasive conduct stroke endarterectomy. the Turning an stent-first tailor asymptomatic either Medicaid a needs strategic the CAS physicians Prime severe stent acute

to study the our component unwavering community reflects Our long-term represents our in critical growth investment in strategy. a commitment and this neuro

to this share in approved anticipate has enrollment that QX patient study, we of are We first pleased and our FDA year.

I Craig? call leadership goals the the years than a to general experience to welcome the Vice the and growth Executive Pete brings management joined truly achieving review turn financials, objectives. At addition over turning to financials. to more of our America. team, and of North to InspireMD I'd world-class over as latest like and Manager like is what and who Ligotti, this January President Pete is General Craig the I'd XX to capable Craig commercial of in point, Before believe for to call

Jeremy Feffer

Thanks, Marvin.

total Gross increased Mark $X,XXX,XXX overall the markets. This XXXX, $XXX,XXX the from of ended XXXX. of expenses. XX% and $XXX,XXX profit resulted recertification, increase increase quarter near gross increased due during fourth fourth $X.X XXXX million to expenses the of $XXX,XXX fourth XX, This primarily loss $XXX,XXX XXXX quarter decrease miscellaneous quarter funds in to $X.X predominantly of deposits. Net quarter an income and fourth compensation, to driven the XXXX. December XXXX. fourth million interest the per $X.XX XX.X% in the compared of to $XXX,XXX, to securities, and income $X.X higher new during was to XXXX, of and basic end increases to for for a or of short-term XX.X% expenses X a revenue, by $X.X for in net related for in market the or share compared the existing million XXXX. for trial. Total X diluted increase was XX, XX.X% by marketable XXXX period as the or loss per the million compared by ended the million, This money from compared the of reduction which fourth due C-Guardians $X,XXX,XXX bank of increase for in basic increase we during fourth quarter and of investment or share-based subsequent diluted offset XXXX. margin was increased revenue the the of profit clinical to quarter to fourth $X.X quarter offset increase in months fourth the quarter fourth of growth XXXX salaries is totaled the the XXXX to quarter $XXX,XXX same XXX.X% million $X.XX from to or an Gross share the months December in occurred For CE expenses quarter operating XXXX. Total were of completion for for of $XXX,XXX from XXX% primarily financial increase and a of This

equivalents, short-term million As marketable of our of XX, now were XXXX. That questions. for remarks, securities as to December concludes open million $XX.X $XX pre-prepared and XXXX, cash, Operator? cash and we will December call deposits bank the compared XX,

Operator

Sandler. [Operator Adam Instructions] from question Piper first Our with is Maeder

Adam Maeder

some just to about us puts finish but CGuard and nice just guidance as kind a to of and the the think that could wondering Maybe standpoint. potential start, we new know walk through line And be of pike with you on year was business Congrats the we SwitchGuard think about international the XXXX, down for I follow-ups. from don't the you year. I a takes out as hoping have of some the business Europe? couple may coming specifically products top then had this about in And I there, Prime

Marvin Slosman

Adam, thanks the question. for

European to as our in our We'll heavily do relates so. business, we're it continue to So commercial continuing to effort. invest

As perspective certification, been And a challenge before a which channels that MDR has the you development of under it the was from we of this challenge. MDD. to of a MDR advancing allows to bit product know, now of us open some up products, a those a new pipeline overhang and look have bit

it open new are product invest to markets. heavily and would into in looking double-digit given So we'll build try the markets no It our grow aggressively, to pace. continue grow But our that, to access the to business. to I to a say, to a market. continue that great to and it's plans hopefully integrate that our pipeline balance, continues We're we at foundation limit on to us

Adam Maeder

Marvin, helpful color, I appreciate That's that.

to CGuard and it? on approval, just Prime on any 'XX sorry push 'XX? in that can Is bit, you put do Just to come that a Mark expect CE you event? point but finer And little you SwitchGuard

Marvin Slosman

Yes.

is 'XX. in to CGuard Prime hope Our have

I delivered to as some body our have said, have our by We time. ability which files been, reviewed, notified get restricted somewhat for our to been

able quickly, CGuard that, that into to Prime we'll process, 'XX. so hope market go the opened will And in integrate that review be now and that's up we that

what the it assessing relates to potential return on that trying of and market As the we Europe and out how looks SwitchGuard, we're TCAR that advance still to our in investment figure through like. channels

into So Prime likely get as for but is outside quickly as we that the purposes, will our it market shift of plan CGuard can. to 'XX,

Adam Maeder

That's disclosure still strategy there for is, journal we ask the press potential the form line a then about I with it. I'm to of release C-Guardians helpful. to will be from at are ask good U.S., I guess, trying wanted over And I I got commercialization guess data the you the pivoting to consistent past lines. back call, time hear the timelines -- to of in the publication for what top tracking community for the medical results helpful. the Just a any half on expect full investment investor and/or in would of disclosure in the wait a should color presentation or to a kind or strategy meeting year? more company.

Marvin Slosman

is did as Yes, we're more to setting to that, a is we what do period a want to to XX-day setting much disclosure We there Adam, in robust to out that our time trying possible. that to why reasons The as happening appropriate it data prefer in in think I our pick do time conferences than conference would release of we've the intention obviously as data. disclose done quickly able to intention press format. time. we certainly with previously. a just There's challenge the but this We're do and that and being to that trying with do are is what of see it how looks, more lot as

that gives know, a possible. out greatest little us you summer intention we're as to But quiet, trying quickly response. As format to the match it as a get in so our the gets

Adam Maeder

the are was plans half commercial us. and I sales and got about there maybe kind to hoping for kind And will spend 'XX? for if hiring. I illuminate the that year presume When ask any that's you helpful. just plans force in of for of could OpEx it. just you I but color you That's about today? was Where around exercise, the I a to look of back Craig, of talk more onboard folks? the

Marvin Slosman

how of Shane, launch begin so to to the and So you We've is time a of our most architect year, of tremendous intention figuring commercial the on the approval approach on our with as we territory back so coverage amount out out build and go-to-market forth, the get infrastructure size, mentioned. optimal to build spent and strategy. to half

So back we're is lot a as be well. developing infrastructure, year in. board tools, the General on half done there's terms that's as between U.S. to the those our be of heaviest of concerned, got but infrastructure hiring investing and then all We've now things training as would work far in of on Pete Ligotti now that a Manager as working

addition So the effort ready to having we commercial support in a want team to full to go. be of able sales high-powered to reps

Adam Maeder

if a me, just for And more helpful. That's that's okay. couple

U.S. study. to So the I TCAR wanted about ask

should commence? patients and when share in the to you've and on of that the even study can to that as number back what a still Marvin, endpoints. then terms want I PIs. So think those you expect just timing good. study about are follow-ups patient half for we announced that And is 'XX event? SwitchGuard, design of commercial sure And we make timelines

Marvin Slosman

Yes.

in very out Adam, entry SwitchGuard So meeting the a TCAR productive map mentioned strategy we had our FDA call, pre-sub U.S. previous to into we for and our as with our

following so And their we're lead.

like to the some addressing We advantage also this as sure were position We we that second that to Advisory we're amount mover world-class gathered as from technology. is that make they open developing want tool of topics Strategic tremendous surgery the a those felt community and take addresses important. of that next-generation sure of our vascular set We can the long make of advantage some Board the feedback of things. a

pathway. that design into ] integrated approach the device get then adds V&V [ and that the of layer and next regulatory our and So we've into feedback we

structure identified we've is our PIs. in answer short got and place. simple a the So We've

to in year our study terms enrollment our the finalizing FDA remain will depend the to approach FDA, started discussed get on I late that of likely consistent, for 'XX but late and in with think have approval. But direction we've timelines that availability we that hope previously there. validate We and this

Operator

Our next question Global is Partners. from Ben Haynor with Alliance

Benjamin Haynor

for sounds me, quarter? provide quickly on [ How do just to like will off can study. that up enroll? you stent other there? It you tandem design, the XX-patient First the Any color pick next lesion ] expect that

Marvin Slosman

you. to from Ben, good hear

or we've things thesis allows data other that we pace a at I Saddiqui the as to to true. drive really the continue is is along. We're CGuard Dr. not at the a Institute believe perspective Jacobs going with provide we the thrombectomy this profile that acute and in fast EFS, us be is a to from march very to test structured FDA is to sure intended to event. think group The This applied. as setting performs and be go going how to the go behind are in to being do to finished theory the a carefully, to behind deliberate manner, safety whole things case what make it EFS

And enrollment. any so to put timelines I wouldn't

what's I know suited think acting that's not a we the the physicians from that. CGuard think that And important taking community that based dedicated stenting on our on neuro There's the We a feedback is of most that feedback. place. in some we're settings. of for carotid and lot commitment making optimally there's the is to sure these label for that

validated, to then that that step first sure from go a going make is there. take step we'll as to it at big and time a and use thesis we're EFS a So

Benjamin Haynor

Okay. it. Got

about flowed guys, but surprise C-Guardians, that's the then? I So you that's good. we of from since then just share VIVA last and on XX-day you And the reactions with guess know in that I call, for a [indiscernible] seeing big the methodical data talked kind not can anything there, approach

Marvin Slosman

was a to perspective, was which to very in to Ben, of that with presentation approval. foundation a of tremendous on remarkable steps overall, next of movement our great consistent have. real-world and have caught lot present people to get the but follow data, our From say won't I confidence it favorably it was by that a there's received. surprise, we've to the ability here prepare comprehensive I to got our package was think also X-year amount so and and forward Obviously, we secure take been so FDA our FDA. up on But the data XX-day far, a experience,

point. to look next but the we'll excitement in this to as readout So that this process, up step next

Benjamin Haynor

Okay, then sense. that makes for Craig. And X

have kick Is as R&D, year year C-Guardians running kind this and how should be up model On thing there any we you in particular that through -- anything this that II that should about? off the the just year? goes that of or thinking quarter we particular on expenses in the a they anything step later as

Jeremy Feffer

Yes.

think well for for there's that you I for II. as the think trial going as to a C-Guardians SwitchGuard, R&D, should ESS be the step-up

just, to yes, within I quarters, of would couple a start So the first already include step-up.

Benjamin Haynor

step for -- continue up couple step does then -- then and up? thinking, and to or level up Step of is kind step a of Okay. that the off quarters out

Jeremy Feffer

no. the no, step No, it off. In then level first quarters, just couple up a of and

Benjamin Haynor

helpful. team maybe Anything you I And bring there? full that do then quickly a you can team? How big for out us mentioned guess, That's them with help a sales is reps, how you on? Okay. -- both high-powered else the bit of that little Marvin,

Marvin Slosman

Yes.

considerable done this we're some modeling scenarios. and both I We've think spend time seen working different we've before. to of through amount a this,

market, number think optimal direct XX of the reps somewhere the obviously and support with dedicated structure clinically U.S. is I full-time sales other the things. for in ballpark

around we're models so And our that. building

each make to skis. same In of terms robust response of getting and the that the we're in is anticipating not our very absorption But of the approval. markets goal addressing that time, to we're sure market, a we're appropriately, our ahead at

market strategy. sends go-to-market buy going address we're ready signals robust, markets CGuard. we're and they're period to what and kind But fully get as the would I obviously to about hard locked time. are can that take commercial most sort runway working we're that our we on a us people figure how to use out X-year on anticipate those in of going these loaded to fast -- probably go of and to It's as to out So in figure of

can So market lot inquiries reps the being talented imagine, And you first as in and this they lot a had as love step. us direction we're really architecting a next headed. we've see carotid step the of of from that of plan's sort inbound in revascularization, this

good a inquiries good indicator of inbound how So can place. a are we always in land

Operator

session. back hand our comments. like to for the I question-and-answer would conference over to concludes This Marvin closing

Marvin Slosman

Great. really operator. calling Thank and a for robust you, to We XXXX. in appreciate today, thank we're looking calling forward everybody in. And very you

Operator

conclude Thank today's conference. you. This will

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

InspireMD (NSPR) 6 Mar 242023 Q4 Earnings call transcript