NSPR - Earnings call transcript Q1 2024

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Operator

Greetings, and welcome to the InspireMD First Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Chuck Padala. Thank you, sir.

begin. may You

Charles Padala

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

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

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

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

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

call now Marvin, over It turn Go CEO to my Slosman. is please. of Marvin pleasure to the ahead,

Marvin Slosman

we market Thank platform. carotid morning. we the carotid XXXX, were you, joining I'm XXXX for during best-in-class leader to with in Chuck, this we first and momentum our CGuard be as our quarter of mission able which thanks our pleased with that call exited to revascularization advance stent everyone a sustain the to toward report to

EU ability build continue topic representing sell our of to pipeline under wanted under CGuard that With in we from removed recertification few we also performance. markets enabling first will million We our the our quarter nearly product OUS in in generated $X.X million, formal growing cover our over our development I this revenue uncertainty in to with continue on first to touch certified a MDR now our countries the granted, to growth XX% provided highlights Craig and shortly, reported as parallel focus. XXXX. financials U.S. we've while quarter MDR of total derisked $X.X of but

the sold CGuard XX.X% sold XXXX, quarter of X,XXX We of the stents XXXX. over during growth first first X,XXX of representing quarter during stents the

Our XX,XXX stents experience sold date. now real-world CGuard exceeds to with

Turning the stent stenosis. now C-Guardians the CGuard arterial evaluating efficacy ongoing carotid carotid safety of to of U.S. system our trial, pivotal the is which for and treatment

of abbreviated ipsilateral or of XX mortality, composite reminder, or DSMI trial a events stroke XX the stroke procedure. myocardial day including day from the a XXX as endpoint this post of is to incidence days post-index through all-cause primary As major infarction adverse any death, procedure

XXXX, also Course of as This presentation study. Metzger, May Leipzig, XX be Chief the by Chris on Health has Interventional in and C-Guardians XXX Prime U.S. XXXX utilizing July the carotid from of outcomes abstract Between enrolled X-year CGuard prospectively patients an We presented known in Ohio Dr. the the next-generation investigator single-arm been Vascular is June lead were Europe and which study XX the the stent performed at at XXXX, presentation including at our recently for and in LINC, system, accepted scheduled Leipzig announced platform. CGuard sites will Germany. System

in analysis in the in trial fall which the intent-to-treat Recall be VIVA XXXX MicroNet the just and X.XX% gold rate myocardial XX-day population. at the with death, all-cause the mortality, follow-up was population from infarction and of presented of X.XX% that the demonstrated protocol stroke in standard carotid CGuard believe like innovative mesh to these results We have potential position analysis implants. the to our

approval premarket would XXXX if we our positive, submit of in This $XXX.X to transformational a later would this half or of time prepare last first tranche application, from line for approved. the Assuming the are launch U.S. unchanged million that of while results the a XX-month XX-month It's on commercial data PMA be continuing trigger year to to outcomes financing prior is first we up guidance. also the noting announced May. from C-Guardians worth track

with that Board by Nantahala, of Rosalind, certain X private with members the million, each placement, tied $XX.X million the for achievement to led and we prespecified exercise Recall from Wace milestones. of terms received was of of InspireMD warrants Velan OrbiMed, which the Soleus Marshall $XX.X participation upfront the upon tranches

release from the public is points follow-up the pivotal trial. end related secondary The to of X-year first C-Guardian's of primary and results which study

subsequent our a CGuard we've quarters half Prime targeted X for CGuard of brief the of of clearance trigger funding which sales As announcement system, PMA tranches the from premarket FDA the kit and XXXX. remaining C-Guardian's TCAR stent anticipate next potentially for receipt of back would SwitchGuard year; United milestones of the are receipt prime stent include half in the for FDA which of the of in X of to the that carotid the reminder, approval, the completion States, the commercial we first

platform enhancements, complete Our plan if next-generation cleared, offering CGuard set Prime study our best-performing TCAR compatible the implant. enable submit system, including a and tool remains of with neuroprotection kit on accessory track, and SwitchGuard C-Guard will to our stent TCAR and

blood As an to stenting passing a to SwitchGuard to the it reminder, prevent brain closed to traveling generated designed loss the the the filter procedure and through in during during carotid blood from embolic returning NPS patient the integrated circuit procedure. a debris minimize is a

and our addressing and toward said population innovation when the TCAR done tools, both broadest further CAS patient care. reimbursement was standard technology an methods of in shifted a anticipating first and time investments As the procedural endovascular before, ongoing tides we've

October, and patients. include coverage asymptomatic expanded beginning Last is toward final to we last which procedures and of shift of CMS' the from standard-risk a decision surgery CAS stenting less year, believe by both away marked what coverage invasive highlighted national TCAR

Radiology With industry were We CGuard in Dr. we of implant Good of pleased Surgery be Dr. in Louis, lead PIs. Vascular Geraghty, this very to and in are EPS, announce well that Hospital Washington will and change. believe to Director Samaritan we at positioned and Medicine sea Patrick Chief as the Missouri, Muck, of St. addressing Pat in our at University past Professor Surgery February School a serving leader Program Cincinnati, best-in-class be Ohio, this

to a our these strategy. leadership established bring Together, knowledge, of and to join and and an field They we that Muck TCAR in very insight able us guidance knowledge thought and initiatives. Geraghty from their objectives group carotid build already of we're Dr. Dr. of extensive in be multidisciplinary as experience and benefit direction to are fortunate leaders interventions, wealth providing

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

stent acute its demonstrate using these designed procedures. We study embolic mesh with stenting during safety proprietary that will is superior stroke our Prime believe this procedures. in to carotid provide feasibility CGuard MicroNet and prevention of

represents we this FDA The long-term a be and quarter. this growth critical first community in strong of reflects commitment the strategy. the investment component patient Our to enrolled our study anticipate study, our has approved the and to neuro

this to point, over turn I'll financials. At call Craig? review the the to Craig

Jeremy Feffer

Marvin. Thanks,

quarter to first from XXXX. of For the was increased $X,XXX,XXX increase during revenue the by existing XX% first markets. quarter $X,XXX,XXX total predominantly driven of in XXXX, This growth

of quarter higher from the training primarily first capacity of for build This anticipated to costs was a profit the or $XX,XXX XXXX decrease for volume first decrease a of of new from profit increased for Gross XXXX. $XXX,XXX, requirements. of gross $XXX,XXX resulted quarter hires XX.X%

share-based first increase recognition resulting due XX.X% first of of XX, XX.X% ended compensation of an X quarter million Gross compared This months of of for the the March quarter Total margin the the million, million of second XX, from to $X.X quarter grants during March $X.X decreased the to from and XXXX. primarily XXXX during $X.X XXXX, to or X were for the the was higher XXXX. expenses increase during months XXXX operating XX.X% quarter made XXXX. first ended

of This increase XXXX. for investments quarter increase Total $XXX,XXX, first income compared of in market was bank $XXX,XXX primarily from in to the XXX% or deposits. to quarter increase due $XXX,XXX money marketable an funds financial was short-term the first for income and securities, interest $XXX,XXX

first the diluted loss basic of $X.XX period or in or basic and share for quarter million $X.XXX Net a net share compared $X.XX and same $X.XX per XXXX. to million totaled diluted XXXX the of for loss per

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

call the questions. We open will Operator? for now

Operator

Piper the [Operator Instructions] comes question Sandler. first with line Our Adam from of Maeder

Adam Maeder

here. I submit is progress I trial the package really on that you around Maybe at start, C-Guardians the to ask about this LINC. and question data more quickly and guess see going that set Congrats later we're the how the can information wanted to to month to FDA.

the couple of clock get process we had could and start? better FDA a Just trying when review follow-ups. a then sense their see for And to I

Marvin Slosman

Adam, thanks for the question.

the efficient our relates gives approach, chosen and felt fastest like So submission FDA, as to which we it to a that most approval. modular the pathway with us we've approach was expeditious

it data, then be the module, and right processed FDA to with which around September time this sometime So once into frame the final will anticipate we the or shared be present goes we now. August

and submission with will and be right our on, then. seems submission the all certainly So we've to is that that stent. take hopefully, our date now landed place that familiar FDA

half that in most of year. to hope this the the first way get to we so efficient approval next is And

Adam Maeder

next to continue product. switch lines over just track. time or the TCAR I to for confirm to that the And SwitchGuard your I to those question, wanted wanted

you are to Is the C-Guardians correct? the end year So SwitchGuard And of still II in approval in you by expecting year? the are the a study XXXX for commence calendar then U.S.? late that enrollment anticipating still

Marvin Slosman

Yes.

landscape, me let the for approvals here. guess, So present I all

first the of have system Prime the our plan our by in neuroprotection CGuard followed approval SwitchGuard So second CGuard the the of Prime full of with TCAR And kit the to XXXX, half a is CAS finally, in for of accessory clearance first 'XX. half 'XX. indication half for

our and performing us encouraged gold vascular feedback new lot what to a continue enhancements the TCAR surgeons gathered they procedures. from from from our TCAR establish we've expect on feature to set they've and to standard and they of of build a their believe So offering

and So into the CGuard then both progression, finally, And of from that that of indication the a with the approach our to comfortable bit regulatory we're then feel unknowns SwitchGuard. CAS pathway, time effort. handling with of the with we've we little how built course, the and Prime TCAR transition

Adam Maeder

II, C-Guardians start is still that by this later year-end? year to expected

Marvin Slosman

that's our That remains Yes, plan. Yes. consistent.

Adam Maeder

moving then lesion And tandem feasibility over early to study. the

just here And patients. see the lastly, study kind think like And Street heard enrollment correctly, I expect these trial are And this? kind maybe good then that? quickly very is how I to a I What sick then set? understand in expected then can like level do And confirm And you just do audience of more Wall have that a help first outcomes enroll? you patient we follow-ups. community expect look the or data? couple maybe should of for when to QX,

Marvin Slosman

question. Adam. Great Thanks,

the whole. that neuro start a really me through the let So is the Tandem the to to trial focus EPS fact with the refocus community as our attention with

So label look Tandem. notwithstanding objective in our trying to a for specific to

to continue focus to goal on the Our neurocommunity. make we sure is

FDA So that we that patient as in approach. of cleared enrolled, enrollment. different It has will a XX the said, And patient first anticipate that, the very be is scheduled quarter. EFS around set objectives. second is we

stroke by And in is because nature which are mentioned, of the as measuring quite acute these the you scenario. standard by we're patients different success an

population. really we're trying sort what's segment and because have obviously, the considered to that, measure it's success to stenting, against of of to important work be a we'll carotid measured that standard So through

a but it those I big highlight a the define that's the speaks all to being outcomes thrombectomy and different how success neurocommunity of definitely we it's look outcome done, the in terms like. think protocol of with in become what

clear that we'll EFS that's and So we we're sure the present from present feedback, that especially data going work to the as that, hard to accordingly. that make get and

Adam Maeder

there, Marvin. color Good

Just a more, may. couple I if

out of the P&L. kind light. switching was that for margin to a rebound to 'XX, just the to near for call quarters? then little for margin offer broad maybe over any of you we up subsequent QX at to in think level Just expect bit XX% juncture? strokes the that to Just Should trying Gross high on Anything through there. XXs this want gross cadence 'XX and margin gross to

Jeremy Feffer

people them starting for Adam. growth. hire I'll for increased and more Yes, that, forecast to We're take train

and increase reason So that goes sold, goods in the the main to QX. cost that's of for the

We in XX% to be the United only of compared selling selling quarters, When higher. the later some user of expecting we in prices much the in have get a launching we're United we will where user we much distributors end upturn they'll we're much Don't are the forget start price. actually in go getting directly, via are Europe, price XXXX States and also higher higher to Europe. the an end actually currently when States

Adam Maeder

ahead sales aggressively going the half you one just spend. going think And of to Craig. the how are U.S. do just the launch in I force OpEx the to then OpEx you, of more we forward, How kind about XXXX. spend first mean start up for of build on

Jeremy Feffer

definitely launch next in closer get the States. anticipating mean the to -- higher United of over going about X years force closer the it's we're X states. sales I to Yes, we as go over a the operations in XX-person and

increase we'll quarter, for people people to more and be but manufacturing our So the is also U.S. well. also more as and facility OpEx each costs adding going

Marvin Slosman

operator? questions, other Any

Operator

At back closing I the over turn questions. this would to further no time, like to floor for comments. management we have

Marvin Slosman

and to XXXX create continuing time Thanks taking call in for momentum and the Okay. Thank forward participating. thank value join get today year. ongoing We've to support. everyone much. you begun to as later look I'd significant to for very we for the with the like the

Operator

Thank concludes you. teleconference. This today's

at disconnect for may your your you lines You this Thank time. participation.

InspireMD (NSPR) 14 May 242024 Q1 Earnings call transcript