Earnings call transcript Q1 2023

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Operator

Good day, and welcome to the InspireMD First Quarter 2023 Earnings Call. All participants will be in listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded.

turn over to Mr. like I'll the to call Now, Advisors. Glenn LifeSci Garmont with Please go ahead, sir.

Glenn Garmont

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

Marvin Joining Chief and Officer. Executive Financial Slosman, us Chief InspireMD Shore, Officer; from today are Craig

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

contains and as For and by XX, accompanies described more that it. revise in information most occur reports this InspireMD's recently is reflect time-sensitive Commission any made please disclaims information InspireMD refer about law, Except only XX-K with cautionary risks, periodic and accurate publicly XXXX. that circumstances in call. XX-Q obligation to U.S. any the to Form The update statements after the Exchange press filed Securities that or InspireMD's call, to these risk or May release filed today, the factors as call events Form particularly of information on this required

It Slosman, is call Chief the go now Marvin my pleasure over Executive please to to turn ahead. Officer. Marvin,

Marvin Slosman

last development by significant The Marshall our private $XXX completion Capital. for Rosalind, financing call most morning. this a of placement up Wace InspireMD's OrbiMed, since doubt, update financing a and Nantahala, led of everyone most million. the transformational thanks Velan joining you, was our is Soleus, by to of significant and with in Thank Glenn, participations Without history a to and through milestones the the quarterly one

institutional also offering. have Board These participate It's are noting regarded elected number certain our also most the investors. worth members that of medical technology to the highly amongst in

growth company's fuels disease strategic to vote market. by of and change of goal confidence standard We the carotid our inspired this humbled and the both therapeutic enables are which our in care

engagement, upfront capital, with totaling an are to the $XX.X fully each to of million following tied we initial milestones to milestones. Pursuant tied received warrants The the additional exercised. tranches million XX.X $XXX.X four in million gross

the line U.S. our trial; Prime CGuard the five stent the IDE approval, Prime second, announcement CGuard of fourth, third, approval receipt and XX XX-month First, top the of commercial carotid for of FDA quarters for SwitchGuard system PMA, system; readout first the C-Guardians FDA from market. cm; of the in ongoing the data receipt FDA clinical from of premarket carotid trans sales and

for our a catalyze indication U.S. architecture. funds serve countries, and The lesion execution, products territories, approval and are advancing including to business Mark and U.S. the our intended and including tandem in launching of base our new milestone CE further current our the establishing operations in CGuard commercial

making carotid sheet inflection in this a through balance technology. strengthened, of our commercial drive to patients from novel to build the to CGuard deeply infrastructure our U.S. of can we who artery the accelerate to regulatory while broadly benefit significantly out class many CGuard EPS by stand commencing advancement available disease the world With pathway way committed with advancing plan value

implant performance unchanged, our focus The mission of patient is which business to outcomes. remains on positive and

surgical infarction and CGuard and short that well from reminder our death, patients peer-reviewed nine EPS endarterectomy. of superior demonstrated lowest stroke as the those competing long-term to rigorously by data unmatched compared of systems studies superiority myocardial X,XXX have enrolled first complication of rate outcomes measured clinical approximately generation as a As designed, the as stent clinical

our in million, generated This X.X% increase markets. of EPS sales was quarter driven a revenue of XXXX. We Turning in representing now by of $X.X to X.X% served first growth over XX to total quarter. CGuard the the

we shared the to first in and November our our of created of quarter. loss certification last shipments, the in sales second of a due As XXXX reporting, temporary restriction result the in MDD gap which sales quarterly half a in was

is maintain It to for testament focus is work InspireMD despite interruption were this growth stent able CGuard the for temporary able sufficient access importantly, avoid best significant our were patient generate note that and that of with patients entire slight volume we're able procedural we year-over-year address in successfully to our to markets of and It inventory patient tireless more to of restriction, a loss revenue channels for but the our to availability we to in team maintain needs care. and shipments.

under directive the in CE marketing the our transition Recall delays medical significant in new medical the the and in lapsed EU certification. transition with certification regulation device its the audits temporary European year, by that and or MDR regulatory November MDR. approval application regulatory framework, documented MDD from This framework, well bodies existing of govern sale devices and XX Mark and of of which as regulators resulted processing European last

companies The the challenging the MDR revisions, industry years for its purview. medical all has under has delays deadline entire multiple than taken three more device changing requirements undertaking and fall MDD and deadlines, the made EU combined this serving update that medical constantly This for at transition requirement certification risks. with market device with to a complexity, changes, putting

complete to efforts. In possible proactively process to which we able as partners sales, shortages, our to have we to with resume successfully continuing inventory reestablish avoid are our cadence to work distributor available the and provide now normal much MDR while sales done as anticipation, in

than greater CE with territories served in As XX%. Mark a reminder, our share exceeding some enjoy over of XX% market half we

two standard the and on CGuard delivery growth with surgery new stent enable ground will system. efforts to share continued our platforms the the stent believe of of launch together a conversion with We accelerate care of endovascular

range broadest uniquely base, positioned With delivery accelerate believe the Our mission first endovascular physician CGuard last of full we with convert serving implant vascular of this to are a an standard the to remains first segment surgery we best-in-class medicine unchanged, conversion. to options line a EPS. multidisciplinary

turning now to U.S. activities. And our regulatory

utilizing sites XX IDE patient and recently trial this Our in C-Guardian successfully treating recruiting a very patients. milestone that was the generation forward trial step treated stent first advancing stenting next Prime, trial enrollment robust May used a pace U.S. continues the We for company more clinical on for at company's marks X, significant active a CGuard announced with with Prime the marking significant CGuard This test platform. a setting, in in procedures.

we've continued rapidly this of Since Prime in the quarter. set final end with that completion enroll case, of first by the anticipating CGuard patient to enrollment

higher performing offers of constructions much once and handle we carotid staff which new and approved and gives an tip the to reminder, benefits Prime degree including numerous confidence utilization stent catheter trackability This will easier. believe a innovative and and which a launched. As its in CGuard makes design, revascularization, to and contribute confidence advantages physicians stent physicians much deployment

PMA Americas. in we've as critical U.S., vascular in including hiring advance of will and the to our In us enrollment activities of U.S. commercial we market. in process preparation completing space, the commercial our After get readiness commenced Shane test the C-Guardians, parallel, go-to-market CGuard to submission closer approval the of seasoned lead Prime GM Gleason, [indiscernible] executive to the the a in

the of CGuard the business remains EPS To the patient drive we've terms single of we delivery value important fully platform community. potential In vascular new core realize developed focus carotid outcomes. as in pipeline, utilization of stent most our the implant full two platforms the the of across on CGuard to specialist variable however, as broader the

compatibility CGuard the utilization and platform plans which Prime, protection In As implant. regulatory available TCAR best development, for development with with be our our noted platform. test standard shaft will approval, believe SwitchGuard, earlier, our stent versions we TCAR launched combination, continue in we of both to transcarotid short advance will enhance neuro and

financing, investment proxy tremendous space we which as for the we're transformational potential that with a future. a this toolset value to focus our breadth incredibly focus market this key as a The unlock time of of this this winds as our market change company serves differentiator the a transition. bright evolving yield as segment. work In believe and of We a reinforce us and revascularization rapidly will our our stent-centric as of on tremendous we will endovascular proud be summary, for and work direction in we to first carotid of for total look lead

quarter that, the call turn Craig? I'll first to With financials. over the Craig a review of for

Craig Shore

$XXX.X other you, in into Marvin. entered warrants warrants like in a this would common with I securities a healthcare by sale aggregate by of shares regarded for We bring Marshall begin prefunded investors Thank led investor's highly up review that to a and to election morning can each participation or at recent financing. significant million. agreement of Wace with the purchase our

million additional This bring an tied we four milestone-driven million of received if are to initial an totaling exercised Marvin of warrants would fully to gross indicated, million total the approximately cash. $XX.X for with upfront, $XX.X $XXX.X grand warrants million. a $XX.X each tranches us As

warrants FDA a and of The following clinical for C-Guardians the FDA five Prime the receipt transcarotid States market. trial, receipt milestones, PMA, of first our XX including data CGuard the system, from the system to premarket carotid of for tied stent approval CGuard commercial of in IDE quarters centimeters XX-month reporting sales Prime the and United the are the ongoing the FDA from approval, SwitchGuard

increase for revenue increase of by driven was to $X,XXX,XXX a EPS. quarter increase sales now X.X% This generated Turning We the in total the of quarter. XXXX. first $X,XXX,XXX, CGuard of a X.X% over

under the that Mark to of During shipping orders company's backload CE over the the to quarter, allowing company past The the reinstated of half directive, to worked and the remainder shipments months. the company was the the countries. second the reduce resume the few EU of sales MDD accumulated quarter product

quarter EPS for not with inability first underlying temporary remaining We $XXX,XXX in quarter. backlog approximately quarter for to revenue to ship market ended of the is of CE the demand Mark. half the real due of the the product a expiration quarter-over-quarter of during to the our that the believes CGuard InspireMD first XXXX representative the due of increase company's

to under review process for The company MDR. to continues expedite the the recertification work

labor. by XXX% in material a This increase resulted and gross or of revenues, in March and a from For the profit three previously during related $XXX,XXX ended $XXX,XXX three the the as $XX,XXX XX, decrease $XXX,XXX months write-off less in to increase XX, XXXX. from ended months mentioned, $XXX,XXX profit XXXX, associated March increased gross

XX, FDA increase were factors regulatory to related of to XXXX. to increases three expenses and increased expenses compared XX.X% operating three $X,XXX,XXX increase was an first just the XX, XXXX, the and XX.X% quarter in sales driven $X,XXX,XXX, months by $XXX,XXX of during C-Guardians expenses. for mentioned. quarter This months ended March ended to March the from for marketing margin the XXXX first X.X% XXXX Gross during of Total study, primarily or due expenses the

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

XX, cash, $XX.X the as quarter. excludes transaction XX, March subsequent were of short-term XXXX. compared bank deposits December the first just the transformational to cash as equivalents and end financing of As the $XX.X described XXXX, of course, of closed to million This, million

the concludes That financial review.

We open call will for Operator? Q&A. now the

Operator

now you. begin the [Operator We'll session. Thank question-and-answer Instructions].

of from Global Haynor Please go The Benjamin first question will ahead. be Partners. Alliance

Benjamin Haynor

Good the congrats questions financing. morning, for Thanks gentlemen. the taking on and

Marvin Slosman

Thanks.

Benjamin Haynor

capital accelerate and First could other it particularly other any bit me MGuard the that with it about raising, off for products might little talk how R&D impact? just a indications,

Marvin Slosman

a and capital And financing gives as that the working I which working us to you of We've been able time. for we're really acute think point we've that exactly things Thanks. in of possibilities to this this those excited that good which excellent stroke fuel Hi, number timeframe we've of appreciate the accelerate some the question. an about is different number acute indication thought into It's pathway forward. move a continuously stroke, which this lesions us reasons. a in mentioned I I one the we're be on for But tandem quite got those and a as think for consider well on [ph]. gives indications. it there be to highlighted projects which particular, having is for capital transformational new Ben. R&D We

marketplace. to that the move we've opportunity prior offer in so the the calls. forward And get So mentioned that's CGuard that we can one in just of things what best example of

So opportunity this for is us. great a

Benjamin Haynor

is it a it. a design like that to Got of trial tell? might kind thought have then in on do or early And look what indication you too

Marvin Slosman

us that Yes. on to financing pre-sub advance expectations that We're unfolds. for working submit our and to we'll aggressively. this allows Obviously a a shortly have more right as a of now with you pathway protocol that good FDA information and to effort

the back FDA. process of the up that but protocol submission So we'll the to in touching be shortly on and market to one,

Benjamin Haynor

it. got Okay,

scheduled on the What that there. stay here? kind tuned ongoing readiness, have should of be you And what hear activities So on expecting then commercial What's to upcoming front? now? do we

Marvin Slosman

Yes.

Gleason we GM on real a as we knowledge, of leading in with the begun outreach of has comes the surgery the marketplace the skills So mentioned, the of and physicians Shane space to as experience interventional in hired well as this Shane depth business. U.S. of process both side and the business. many vascular side of our the already as

and next months, a sales strong building a there's architecture imagine lot the few the presence that can market. over goes you so And organization of into strong in

trial U.S. of with the things XX we're we're proud our in the is sites participating fact that the One about IDE currently of in

both well just with into of so a gives great approval. the of physicians, on terms market in understanding baseline these launch how it leading a we and think contractual systems have we as hospital so post administrative effort start as about the us And

So we have there's clear architect a a that ground a and so once the done place. very takes hit lot but running now between of it approval to takes implement and what to understanding we that be plan point,

Benjamin Haynor

word Okay, hit. XX that And CGuard be got on first that triggers, the like a fair was that Prime soon it. centimeter trigger you the could to the one come? assessment? And me how clearances curious. and SwitchGuard just It the could Is seems then I

Marvin Slosman

would it the of on readout at sequentially think data. I the one, you a first top line be So look take if

future So we closest one if is you point, will. that that in the obviously think

then But separate time, those we is short the for third, current The at well. with occurring the you that four approval of I on the CGuard TCAR sequence And general second the milestones. And SwitchGuard for see to IDE been over shaft would our PMA the that's be current IDE, as and look CGuard obviously, things obviously, solution we've the just in. if for Prime think timeframe the able Prime.

Benjamin Haynor

point for Okay, that during clarification a way about that of resolved to It current backlog for got any it. there QX. it, And had shouldn't then me. Is just the and think like be impact you the lastly, right you sounds quarter? any

Marvin Slosman

a new and in being I make that prioritized And Yes, has to the in inventory. accounts that to Ben. and everyone that all sure those right about in to backlog to are backlog that Obviously, we'll think to and normal continue distributors of major with being markets way through European and sufficient complete clear get it, work as orders able demand. think shipments a We've back well coming that's is our able to as process itself. cadence the

there. you're We're as working through as So correct that possible. I quickly think

the now, readiness freely space. European of in not and the for we're time, into where Although to a we point continued our sell period to at had were we a market production ship able and which the for be is

Benjamin Haynor

Thanks Okay, the questions, the and that's gentlemen, on helpful. financing. taking That's for it congrats again for me.

Marvin Slosman

Thanks, Ben.

Operator

Mr. I'll And to remarks. you. closing the back call Slosman Marvin turn Thank for over

Marvin Slosman

and everyone you. and patients today extremely to a the time allow on any I'd Have Thank continued execute at for to like taking in achieve. our plans is call about we appreciate for well to to I'm the the support. and transformational than and shareholders support. other what company's we're ongoing thank ongoing join history, financing positioned excited what extremely that day. benefit the us to will More point good alike, the the

Operator

today's concluded. Thank The conference for you. now attending presentation. you Thank is

disconnect. may now You

InspireMD (NSPR) 16 May 232023 Q1 Earnings call transcript