NSPR - Earnings call transcript Q2 2020

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Operator

Ladies and gentlemen, good day, and welcome to the InspireMD Second Quarter 2020 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through November 4, 2020. to CORE call Relations IR, like Gordon, to firm. now of President the would turn over the Scott I company's Investor Please sir. go ahead,

Scott Gordon

for InspireMD Stanford. us conference results call. you, Good everyone, update thank Thank morning, and corporate for quarter second you the XXXX financial and joining

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

light InspireMD’s operational be During forward-looking statements, in address management results, that or performance will making the expectations call, pandemic. future this statements for COVID-XX of particularly including

Forward-looking risks results involve those and statements may other cause to statements. factors actual from that differ materially

For by the more recently it. risk filed risks, call today release press SEC Form and this refer most factors on this contains reports time to the Form XX-K and particularly in Except InspireMD’s that Chief revise information the my statements about accompanies to disclaims to turn is this update to today, or events required the any these cautionary of periodic that Form The that accurate is InspireMD’s It with Slosman, call. described over obligation call, of after filed in content publicly the pleasure any Executive circumstances or XX-Q, please X-K as Marvin as Officer. information reflect Marvin? sensitive call only to X, law, occur information August now XXXX. InspireMD

Marvin Slosman

for call webcast and all the thank joining you, you and Thank Scott, today.

and pace included I although fulfilling the and are our in cases, and specifically respond even talked life-saving stent that producing to I'm As outcomes, I on that rise continues the pandemic to created. uncertainty call, at it’s COVID-XX and great deliver products our effective slower carotid continued operations procedures, placement, the with pre-planned proven persists, reflect volume to placing pandemic. challenges happy customer's about earnings safety than as on superior world globally, quarter pressure poise of still we're and to global commitment amid back critical a COVID-XX the elective Despite our providing needs. with first the team pandemic regard healthcare in report in

these will our of facilities However, as I To as gradual volumes and be discuss which well the practices people financial Europe, expanded of Government’s shortly. healthcare by and avoided emergency were adversely as impacted results territories, sure, tempered lower procedures throughout QX the COVID-XX. elective diverting resources reopening are and conditions. even attention treatments result restrictions a system, seeking fighting on implemented to for

advancement period operating a I us of measures this emerge our for challenging of proactive to our from during as continue crucial by imposed for us commercial has to business to perceived largest for approval Brazil of the reach created, throughout however, our seeing continued is times. procedures success some and CAGR exercise with XXXX. ensure in the the announcement gradual which $X.X largest anticipated during see a costs. extraordinary would sixth supply and with and circumstances, world. this continuing for procedures that and Brazil, MicroNet-covered in Underwriter’s the In CGuard help of the we resumption head-to-head $X.X of go to lower Acculink. of and our hope recovery. as The trial, evaluated have SIBERIA approval to Brazilian in offering Abbott with in expansion and in operate which serve Paulo, as silent milestone second our our for announced critical second we've full CGuard significant health use the quarter, forecasted versus an our our achieved after particularly evaluated continued stent. accomplished time America, taken with which SIBERIA creation. and and headquartered important on development by marketplace, And of runway a provides this million company, open equity expected controlled. The sheet under COVID, the infarcts it announced our stent strong June, Colombia. look or surgery trial proposition value of as with more randomized the international growth brain offering our we raise MicroNet-covered implement the the market it's elective high pandemic to financing advanced authority product us important conventional of risk either to markets, better We've This XX-day possible; a nitinol associated value populous critical shaping Option to South revascularization CGuard challenges study $XX.X is even one evaluation, billion were Acculink have In serve the and versus one-to-one QX year, now the like cell Despite ranks cash the results to pandemic the meaningful in SUPRI, as expansion of is a the reemerge Acculink. global of qualified Also efficiency to Labs’ in the three an and a XXX proud we medical to by these that Argentina accomplishing a as of We evaluated healthcare that who patients with and clinical we for distributors from silent growing of the decrease we carotid our consuming showed important We that for this one to the such positive the the focus share threefold Acculink, reach our and an the fact emerging a with country from a on stroke clinical of the partnered in are proxy São will further of achievements heart standard registration which our we also was trajectory expect confirming body and EPS with to is In will that carotid way supports the are, disease. a balance provides The plans technology. XX zero infarct in milestones The and artery to adjacent growing and be system. distribute critical a programs with long study the critical the stent. validation death, to versus post-procedural of for milestone market that expensive to up care in the the pandemic, add to as milestones. in data X% America, resurgence impact We're we Over-Allotment very its CGuard prior work encouraged South represents and and days. XXXX The attack million. levers we'll serves key offering. markets, of as make additional growth evidence the as included This quarter opportunity ensure well including healthcare crisis continue ways our this or completion policies CGuard at largest brain at drivers to managed even

months. myocardial very neurological delivered strokes, stenosis transient sustained protection paper or years results of to the infarcts against data, stroke too been XXX XX-month The the intervention, other strokes the between study’s one with promising. This stent we events. days follow the No details consecutive post-procedural trial post-procedural Without five Journal. At a results the occurred, real-life deep the Additionally, results to initial and CGuard for only unselected with implant the the treated XX-month XX from carotid XX EPS CGuard occurred patients no from into in and of the months prevention minor neurological continued XX EuroIntervention going carotid published XX and events. adverse days event have patients up PARADIGM MicroNet death. MicroNet-covered after

revascularization obstacle As conventional versus surgeons, to perceived a major market, artery carotid data procedures. is also ongoing stent than but widespread XX% more our concerns stenting only efforts safety not convert surgery, this of the who more critical endarterectomy to to vascular carotid perform are

approval design the conditional the period XX, comparison is protection we compared requirements is Investigational impact impact million the Accordingly, a from to upon our to with already testing of trial XX an that that in Exemption ability more first FDA the modalities sterilization study allow the last with performance of The completed than InspireMD believe and XXXX, XX, to We prohibited issue the United of FDA the June now That within us We've of $XXX,XXX granted visualization quarter the the Recall that we EPD significant support quarter initiate perspective would year. had approved approval. to second agency extremely this employed generated $X.XXX of pivotal step shift from letter. of device, of U.S. trial. and testing with revenue of according well ago. year, initiate for market that pivotal stent-embolic the Having said we for June we be experienced the FDA alternative an we first half to addressing specification positioned on approval stents $XXX,XXX same IDE the or our a a three the conditional to days case. approval initiate our clinical XXXX, to turn total With makes a have year the for first product us are previously to months compatibility terms approval would that indicated second. toward from into concurred to contingent sales ultimately and regulatory IDE was of together shipping results. I otherwise our gain The essentially in Finally EPS. additional like data application difficult will study States. to with receipt Device believe partner year-over-year the a COVID-XX our CGuard device. full ended enabling the us the an quarter that during as last of

generated June XX, and pivoted months did as treat procedural the XXXX. For softness to to six physicians patients. of volumes and in as hospitals million realize $X.XXX QX same XXXX compared anticipate revenue million period the in $X.XXX total we We ended for COVID-XX

Germany. those our IDE our South As our in in key Spain, but pleased and our in notably on activities, to seeing several regain the to I'm a addition in timing, nature initiatives least growth into procedures continue expansion terms in markets reminder, elective of execute And region. planned in we in And are Italy, in that share at report progressing. procedures signs markets territories, Asia-Pacific rebound to European of of carotid stenting U.S. to elective we're America, are

device, to of with development. which is quarter, indications MicroNET new leveraging also last pipeline, our use our in stated protection I along a As research for into I and expand in numerous advancing see peri-procedural opportunities CGuard

at So to where and carotid and now driving continue to am running our intact. for ever believe other that proposed withstanding on as revert our cash optimistic treatment we the see for runway. represents our same pandemic a team and work are To organization, the like we're take quickly rebound, toward remain the dividends normal pre-pandemic for necessitated entire artery by extend challenge progress us second the paying to we already a potentially innovation continue as forward levels. in look shared efficient demand during company culture, ability operating vascular firmly the always product disease, that worked prepare initiatives conditions true pandemic, as to back expenses new advancement quarter I our organization, credit to of lean time, enormous still well I we're the long-term is additional and supply lookout to close needed. would I technology to the new ways both the anticipated a as our adapting At a our while ensure to goals. by InspireMD to as support the as we the These

have look our said As evolve strategy rapid market next carotid CGuard carotid that aneurysms, in expansion and the way is the we've in performed poised the surgery vascular a of standard This a vascular toward strategy devices forward Part who working and endarterectomy. much conversion is additional peri community on an our We I've ongoing aortic with as condition protection our of market segment vast efforts priority. view disease significant than procedures the peripheral what pathway. and of why advancing to before, technology number already our platform surgeons same through exploring more of leading we care, years. have is initiative procedural this surgeons aneurysms a in backbone abdominal strategic as vascular artery superior EPS, is With includes artery disease, discussed go-to XX% important portfolio. carotid the revascularization an remains disease done. to endovascular vascular to artery that We thoracic coronary cerebral for the of believe we coming

now developments, as Asia, with we've associated indicated contracts timelines Turning internal certain for Besides been America. quarter, Europe, these and approvals these that and other to and achieve market we our distribution extended challenges, milestones with in channel to has new work Latin partners been in growth. product last COVID-XX we've countries continuing registration key pursuing

We're additional under to that's that French bifurcated and in of remains the strategy. place particularly our special despite French being sales a our for now delaying growth to addition in market model. of the European CGuard addition hit reach We're pillar In pillar to expanding in the consideration with discussions with puts health a allows Brazil, authorities. advancing report our in market by the the pandemic, strategy hard pleased to faster us option the access standard This reimbursement reimbursement. French approval direct EPS our

Asia to financials. both our business, addressable and in of regions market distributor Pacific, as with and Craig? such, that call China I we continue high potential of turn highly our partners Asian Craig for than more valuable terms are And the markets thus these double Japan another discussions over expand to quarter will both priority current represent second these review a for in markets. with In

Craig Shore

you, to everyone Thank joining today. Marvin and

of highlights the financial XXXX. second key quarter for some are Here

mentioned, to former large months was three June ended For decrease to revenue were during the were COVID-XX. in XX, that the to months June to three months accumulated XXXX, patients from ended X.X XX, due XX, hospital June did the EPS XXXX as XXXX. as EPS This postponed volume was is CGuard March ended months not our in third-party previously decrease resources by three The compared June of $X,XXX,XXX $XXX,XXX XXXX, during driven to recur ended months due XX, the shifted predominantly Those XX% the sales June CGuard are XX, backlog equipment the million the XX, with procedures in CGuard June ended Marvin XXXX. $XXX,XXX to due fact during procedures was decrease months as EPS, This during mainly months XXXX to ended generally three three ship unable scheduled that that made three mostly XX, which a of also during shipments sterilizer we failures. shipments non-emergency decrease we affected by large three that ended XXXX. the

XX.X% labor sterilizer receipt increase during XXXX, $XXX,XXX ended decrease in the by from product the June which months Gross XX.X% a received the margin the gross company XX,XXX a driven of of minus revenues, miscellaneous period June reductions of in related XX, $X.X the volume And the to recorded with the flow in the recur decrease ended XX, mentioned. three Offset previously quarter due delays salary three $XXX,XXX reduction by was addition, decrease process, to ended or In operating compared net costs. June reductions This loss of per The in due decrease Total million, a of to expenses decrease XXXX ended loss related XXXX. sales immediate XXXX across $XXX,XXX for the our and Financial XXXX the reasons prior MGuard a a decrease COVID-XX three and diluted gross June $X.X for of just EPS, the same to temporary and same ended net mainly XXXX. of related or period a decreased June for XXXX The $X,XXX,XXX were the share the not related $XX,XXX former of EPS in three to CGuard our in three expenses mentioned. $XXX,XXX same $XXX,XXX ended for quarter the XXXX, associated XX, $X.XX to during loss due $XX,XXX This to XX, XX% reasons to less compared clinical there $XXX,XXX the the cash June during XX, million XXXX compared of was to XXXX for for compared gross sterilization and primarily the three XX, ended mainly June board the $XX,XXX IDE settlement period months offerings. $XXX,XXX primarily approval did in of profit expenses of miscellaneous following offset in from the same were by during second for profit similar year quarter ended resulted in ended XXXX. in XXXX. expense interruption months share compensation XXXX impact diluted the XX, and the decrease from months expenses. compensation during the I've the XXXX. XX, to months in for quarter on almost basic totaled to per to $XXX,XXX ended an the months XX% XXXX, agreement basic $X,XXX,XXX due $X.XX a underwriter XX, quarter March in of an June with for XX, third-party $XX,XXX to period material

questions. cash As the that, Stanford, were XX, $X,XXX,XXX like of I'd ahead. as to XXXX. please go now XX, compared equivalents With of XXXX, and to December $XX,XXX,XXX call June cash over turn for

Operator

Partners. from Thank you. ahead. first [Operator from go Alliance Benjamin The Global Instructions] Haynor question Please comes

Benjamin Haynor

Thanks all the gentlemen. the progress. questions for morning, on congrats taking recent Good and

plan Brazil Just look kind first what approval, and timeline regarding on what does easy off like? of the super is the me there for launching

Marvin Slosman

question. for transition. an Ben, thanks Yes, important It's the

geographically, as are SUPRI sub-distributors prepared context market, well contact a in approval, for the registration their the both organization. their within as we were large there Brazil, of sub-distributors. very As constant is with so we

of and effort advance we this, pre-training can hard the registration pandemic. was so the for approval has online, and of by hit the which, most did Brazil been as you particularly to of prepare much in imagine, And

of our really the pre-planning, as they are that into aggressively marketplace. contracts beginning pretty comfortable now And of the ahead they all So because the and feel and very CGuard able it's they rollout and about procedures in to will go initiate embed now place, CGuard be to confident product.

it more well been we'll that's COVID work video context normal, this will much feel progresses that effort within new the accordingly. than become the as we resolves much done. and prepared how hopefully, the of, And hands-on have see itself, to obviously, of So of a issue

Benjamin Haynor

Got it.

the in waiting everything to completely groundwork's of get just and So place there kind there. for out Great.

– sorry. ahead, So go

Marvin Slosman

Yes. The okay. orders orders registration correct. soon That's The placed that's was as – were completed. the as

established. all So, was the firmly groundwork

Benjamin Haynor

Excellent.

upcoming you pursuing the of with dual standard special also that front? and pursuing of pathways reimbursement. So us give developments we at mentioned then, the time, kind in the should you're and a how reimbursement the on France on the you then France those pathway Can expect sense work, kind the same

Marvin Slosman

Sure.

of approval the in pursue approval the format reimbursement from designation preclude level. achieved were data after higher that stents. identified that us what more existing already that CGuard special that and the France a they within our aggressive CE Mark. what timeline get with reimbursement consulting in much for going But on carotid order asking for based the a and in in to we've We doesn't exist; pathways our firm able one So we for to France to we was is have two be sort believe

to are to registry backbone by of are health So, existing patients their a this opposed in a part in as having approve that the the level of off deeper of more and code. new that authority enrolling will scrutiny obligations terms take code time, working of a order a and bit there

to then and strategy pursue receive because So if both exclusive. reimbursement And sooner, there. launch the to we our mutually was commercial develop our we're code prepared they're not existing decision

direct Our in to thought France is. is basis go it as on a

amount so, reimbursement that take think of context able ASP. of that And I to the of the within being in fits well advantage for full the strategy

Benjamin Haynor

special if then, reimbursement, sense. And look makes does timeline on That would come? the what it the like

Marvin Slosman

that X- it's XX-month somewhere range. in We’ve been told that to the

understand components it's in think standard the probably We accumulate of put we've that, data, and I will hope the window. necessary begun sooner. to much but in protocols the the go XX-month a So that place reimbursement

Benjamin Haynor

though. quick, it's still So fairly

Marvin Slosman

Yes, absolutely.

Benjamin Haynor

Got it.

have kind And as authorization have And of over endovascular things some you that a then, mentioned invasive conspired, big traditional of just not these how like you procedures to open that prior the has seems about it you like open the the – envision mystery held changing carotid maybe been about number the thinking in invasive not-too-distant kind procedures requiring So less of carotid revascularization revascularization sounds converted the there of future? of over traditionally have maybe years. stenting things Can less why in somewhat and maybe over to carotid picture, carotid a have procedure. back may years? how or talk stenting than things fashion a the

Marvin Slosman

Yes, great question, Ben.

first I expectation that procedures. And did did the in not. weren't higher there protected according clinically just context mesh much think of stents, generation endarterectomy MicroNet was of disappointing think I perform I that open carotid expectation surgical or covering, at that would probably our frankly, carotid that with was against area stents evidence to first the not that open mean, stenting just cell they perform level. great a

embolic fit understand is stenting, think to less from to they And occur so post-procedurally, context what's the think and only we these same post-procedurally, that's performance showers terms in in perspective. data MicroNet beyond our the post-procedural events which first we're meaningful are are standard what of about many where and is we're occurred. comparative It's stents, the of level many as issues prevent events. seeing that clinical surgery, I what but our And from advancing in generation so, being these occurring open cell against the most of a not of superiority endarterectomy of is well I able also important discovering measured

and comfortable along is we there. the go solution also So we that through to I advancement focus have think through advance surgeons innovation there's get the CGuard system accumulated more we're think best a open with level with certain opposed Clearly, data to to demonstrated EPS, and activities. our and the as our we've other of and technology, and have with our efforts of that them the commercial doing centers which procedures, we endovascular vascular delivery excellence system surgical

Benjamin Haynor

embolic And correct devices Okay. those then some case? I'm on but is stents, the early in That’s being of me protection the of those kind of wrong, terms weren't used recollection if helpful. of first in always procedures. types they my that Is generation of carotid used

Marvin Slosman

Most protection cell referring able of time procedure itself. of mesh, open is the covers provide embedded the through artery. embolic level was early for when is stents the there being mesh stent in protection. have a which that filter did system I CGuard covering not actual post-procedural The during and the to version our MicroNet stent, the to a of extra

Benjamin Haynor

guess kind of Right. were pretty – was filter protection But much the devices I embolic now I that to referring used… are they

Marvin Slosman

Correct.

Benjamin Haynor

procedures, first In filter recollection early the weren't least always stents of on. generation, kind I that? my was in were some misremembering those another. carotid Okay. But early or that the devices on, at used fashion Am

Marvin Slosman

think that's Right. I correct.

Benjamin Haynor

develop is as into device devices you're and if XXX(k) fall it. assume the then Got can you Is there that? you the And correct those, would that those you that would mentioned share more FDA, peri-procedural And advancing I well? on or any development. with under do

Marvin Slosman

run opportunities, can and things. advancing catheters gamut from number within options portfolio. other other the mean, That's correct. advanced those through a shorter filters looking carotid context We're full of of at different I our a

vascular make in all much opportunities at us broadening our available that look portfolio to a continuing community, more available part the and the CGuard we're much just the surgical of into So general. more user-specific to are to as

Benjamin Haynor

progress, morning, in be touch I that's on sure the Great. we'll I'm Congrats had this soon. all Okay. gentlemen. Well, again and

Marvin Slosman

Ben. Thanks

Operator

Thank call. you. now comments. question-and-answer return [Operator to for the closing the session Marvin of Slosman the Instructions] This call concludes I will

Marvin Slosman

Thank you.

in heroism, with of hope by the to recognize affected staying be health frontline are are the well our and and Many like efforts people sacrifice are and workers is their continuing many COVID-XX I'd customers by as our and our saying been incredible the care workers have selfless care employees safe fighting healthy, and to as frontline Let the COVID-XX, supporting by that and these conclude who are friends, me I of pandemic them. healthcare we resolve, thoughts our for everyone others. inspired

has unprecedented team InspireMD. includes to all pandemic requires the thank look with forward to the you represents response, respond your all, very stand As we that at the been world ready much market, an We unprecedented this support. said, normalization and us and challenge, to which and our for for

Operator

Ladies much. conference today. very call that concludes gentlemen the you Thank for and

all now may disconnect. You

InspireMD (NSPR) 5 Aug 202020 Q2 Earnings call transcript