NSPR - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the InspireMD Year End 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 on 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. the end be June of of hour approximately X, replay the after the webcast call available will one XXXX. A call through to Core now Gordon, Relations would like turn call I to firm. President the IR, over of company's Investor the Scott ahead, Please Sir. go

Scott Gordon

InspireMD Good update the conference end Thank call. us you, you joining results everyone morning, Andrew. XXXX thank financial and for for year corporate and

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

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

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

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

Marvin Slosman

direction of of recognition optimism utilization, delivery despite superiority design weathered by of of historical focused medical and the these proprietary the InspireMD, stroke patient unique endarterectomy, Scott on other value advanced within multiple of way We as in disease a XXXX have invasive disease. is the device CGuard and work, year CGuard's healthcare continue EPS unprecedented Inclusive advance not achieved began call treatment highly stent it the CGuard and a our and procedure. impact establish result and all COVID-XX, webcast for only system and year awareness, that across The physicians built and become positive to all carotid important most platform set clinical you, and goal and specialty our milestones clinical thank community of prevention. artery XXXX during amongst the outcomes artery carotid stronger vascular of to CGuard, options, a a year. joining the in growing the a throughout surgical around by particular, makes Thank the our in as challenges today. evidence body as of many as treat the community of but specialties we at to and of all you of the carotid choice technologies transition measured

focused determination. Our as of growth stability, on our focused team's mindset. to Execution first our financial during performance these footprint, served of availability we all and continued with commercial our times patient market remained with priorities, our the of a strategic steadfast products

to effects levels more pre-pandemic which performance a was and to year top CGuard use we remarkable COVID-XX promising will remains priority. for procedures growing of to expected, carotid served success. headwinds one-time historic events, year normalized the anticipated milestones return vaccines restricted of our treating in a revenue customers rollout life. and for continue As primarily return even the of for experienced and way our artery markets markets. Supporting XX business by have positioned our with disease EPS as extraordinary and the grow Even impacted unforeseen our our to across we elective globally procedures We and of of

number EPS the of systems to carotid We sold best proud and stent grow in performing XX,XXX CGuard market. the patients the have date, receiving to over are to safest continuing

CGuard global market key registration we and goals, We continued for medical secured registration and availability with distribution in Brazil, achieving regulatory CGuard device More Latin penetration product agreement an the the including in devices to investment medical partner, largest the a Chinese EPS EPS recently, in enabling expansion America. of our market for commercial market.

market to receiving also the our To are business Global States. tenacity. Device a permitting Exemption slate. dating FDA and market. former that the United or the with for pursuing this for cardiovascular biggest pleased with successfully the in We in IDE advance US heart to clinical who partnered recently end, initiate our in consultants, approval that EPS the conducting upcoming application expertise clean pivotal CRO, the are of global we CGuard and achievement Bringing world-class InspireMD have methodically settled our clinical provide a clinical CGuard with study to we've dispute will trial measured priority U.S. year the a support is Perhaps a XXXX to past top back with distributor with a was IDE to trials to significant Investigational from us objective

pleased to Chris trial lead renowned named has the of trial we announce Metzger world are the agreed now investigators, conduct who IDE Additionally, to interventional Dr. the C-Guardian will cardiologist, study.

System and addition stenting leading announced strategic guiding and as who pioneer Directors [indiscernible] Dr. researcher execution. trial actively the in the planning Brennan, of York, carotid assist the our Christina of Dr. he welcome effort to the New remains Roubin trial Gary at our will Health involved Board clinical well. in also with in previously We We Northwell artery

needed President Vice both of implement the Mr. Development to step delivery the utilization Mr. solutions Tommasoli broader financial Patrick complete Sales market, our C-Guardian a company In of addition, ability company for operations as is as first as Initiatives Andrea expanding was funding and Senior execute essential out million. have Marketing, commercial goals. through XXXX, to new our our efforts, of and $XX.X as R&D study, our completed of capital our to to with the with most will a well whom support on we recently facilitate build and to team, Vice of Global oversubscribed continue Business develop us U.S. and Strategic provide including our in Perhaps which CGuard. should impactful strategies greater aggressive pipeline the leadership and targeted senior President adding Jamik raise This the

these with Our the strategic conversion commercial EPS pathway includes across CGuard focus who current expansion and we business work and to will vast of line to vascular that in future multiple share revascularizations. growth This growth making the stent and disease specialties market change of diligently conversions carotid for our surgeons by markets. carotid of a on continue increase awareness clinical for perform foster artery CGuard sea number significant is the solution continued to first treat

and combined and which users France, also opportunities, reimbursement platform. market markets effort highly we plan with growth markets, expand provided our and served training with China to plans Korea Japan, prior as as direct growth online part advancing our of of agreement. strategy. sales of for for our effective a or expansion reinstating along we proctoring have In to Centers the as new establish are our efforts support our Asia Speaking CGuard COE programs, COVID educational go-to-market registration Excellence to Taiwan enhanced a overall our in filed well overall initiatives, of

utilization work update to and soon. providing support Finally, advancing of accessories look CGuard we progress and our new portfolio tools, are with forward broad additions to

Craig? is to open As the or protection closed of eliminates is we to superiority stent carotid fourth inherent value With make those challenge that, carotid with clinically to cell the turn Craig that review improving most to a performance and that clinical of It endarterectomy. layered with prevented either and and offers leading fundamental compared committed and in of advanced of the in establish closed We features embolic for we outcomes we to also with superior change worlds mitigates conventional such simultaneously cell open artery our aspire our has CGuard vascular at carotid types, stroke the or practice unique by into stent best to clinical and and I'll disease embolic in protected in XXXX. and as patient prolapse system. had choosing treatment plaque disease of call alternative platform forward the of of past quarter of is designs. to patients and unprecedented firmly renewed to have surgical the well CGuard be as for as which outcomes the year MicroNet artery look protection stents, the CGuard proposition, CGuard's as continues double proven over to next-generation the a with patients believe care events the carotid compromises year-end it Historically, physicians the solution both the proprietary thus with the artery to artery and demonstrate medicine. compromises changing lumen new demonstrated EPS are embolization. financials. associated procedures look stroke. optimism our unpredictability cause end technology back and consistency entrenched of care we of potential market, prevents remain to how standard managed invasive providing

Craig Shore

Thank for today. everyone you, joining Marvin and to

settlement December of during XX.X% revenues transaction were Here for months months amount quarter a to are as a to XX, agreed $X,XXX,XXX that to fourth Marvin negatively pay three were of $XXX,XXX. U.S. was results. Revenues decrease ended the we litigation some December Per former key XXXX. financial a compared sales. impacted alluded Under our with by XX, three and GAAP year-end XXXX against earlier. highlights charge our for to ended the required XXXX the Total $XXX,XXX, settlement we relating XXXX them distributor to

$XXX,XXX, scheduled $XXX,XXX XXXX, CGuard to patients ended three during during COVID-XX volume from decrease ended XX, of which XX, the months also XX, XXXX to three decrease in hospitals the are December decrease three was procedures of at mainly in previously similar from CGuard EPS December to affected MGuard such procedures by of ended was This during or three EPS the a resources volume months Excluding nonemergency of was COVID-XX. due during decrease generally of postponement compared by sales $XX,XXX period XXXX December XX.X% to sales impact $XXX,XXX in XX.X% due months ended revenue XXXX. mainly $XX,XXX XX, to the The XXXX the December shifting mainly mentioned. EPS the the as impacts, from driven during months to XX.X% $X,XXX,XXX

our related we months product XXXX. due associated This as system of expenses impact increase XX, XX, by governments mainly revenues increase expenses related compared offset expense compared imposed development during a This the $XXX,XXX as $XXX,XXX were XXXX from settlement recent $XXX,XXX former XX, three the expenses accessories, the an the of increases liability of decreased to light in XXXX the as advanced distributor. $XXX,XXX miscellaneous $XXX,XXX industry, former months sales in ended the partially gross development resources we XXX% expenses December operating by XX.X% labor material changes a negative had costs. in decrease December ended This months quarter the the of expenses. and gross decrease the travel was in the during three ended added ended $XXX,XXX three the $XX,XXX by to infrastructure, to economic our Gross well our three of $X,XXX,XXX resulted of gross These to of with negative to was due miscellaneous from XX, worldwide three effects the and the distributor, ended XXXX. of CGuard $XX,XXX directors associated months decreased the of profit we months XX, December loss $XX,XXX margin officers of during offset gross the delivery clinical less primarily XXXX of in mitigate the in XX.X% by profit XXXX. increases due December restrictions in of EPS, insurance for increase mainly in COVID-XX. a to For and order XXXX, $XXX,XXX December ended in to partially for in with of the Total were XXX% insurance margin spread a a by decrease and and December compensation added $X,XXX,XXX, settlement of to period expenses XX, $XX,XXX during new driven

or in during three rates. $X.XX with This the ended $XX,XXX for and share a the resulted loss from ended from changes XX, and loss months $X,XXX,XXX XXXX, XXXX. For December diluted same financial expenses December XX, diluted period compared primarily increased months totaled expenses in three financial $X.XX XXXX fourth net increase exchange Net per to in quarter $X,XXX,XXX basic XXXX. the the for to basic of of per share $XXX,XXX

to compared previously distributor. XXXX, litigation XX, revenue months with our of during ended $X,XXX,XXX December was decrease December the negatively a by the XXXX. For due was impacted to ended mentioned settlement the $X,XXX,XXX, XX.X% XX, the XX XX.X% of months XX Revenue former

settlement As I U.S. sales. previously required charge we were stated, $XXX,XXX to GAAP against this under

ended of revenue XX, XX.X% XXXX, impact, XX ended from to of sales CGuard EPS decrease XXXX. the XX, decrease hospitals to generally $X,XXX,XXX during shifted with was due to XXXX There EPS to by a as CGuard months affected months $XXX,XXX decrease such the This December postponement the mainly Excluding months $X,XXX,XXX, scheduled twelve twelve XX, ended the from of during resources months was during December December COVID-XX. XX.X% from in months XXXX, in I are the of the EPS mainly a a as XX XX% impact December also of COVID-XX. patients ended the was said $X,XXX,XXX $XXX,XXX volume to procedures during December or during their sales which also ended Prime XX, decrease by XX, $X,XXX,XXX due XXXX, compared procedures nonemergency MGuard XX mainly driven volume

expenses, XXXX. the same the XX December XXXX, in X.X% ended the in decrease by from profit decrease was decreased December miscellaneous decrease $XXX,XXX XXXX. to related process, to by the $XXX,XXX negative this to FDA XXXX, $XXX,XXX accessories, expenses the as year X.X% on an in system of and of December Once pursuant new was to increase expenses. months XX XX $XXX,XXX infrastructure, distributor $XX,XXX,XXX, related to $XXX,XXX XXXX, of which new approval above added due December months less December not set XXXX. our facilities did expenses, for settlement travel former to expenses to These projects, partially XXXX in offset year expenses. XXXX Directors development for and the of our to paid for to margin and as that our our due promotional $XXX,XXX This and to former $XXX,XXX recent XXXX expenses decrease and primarily during in compared for regulatory the changes EPS, Union, upgrade December a with a year offset in in in resources expenses quality during $XXX,XXX to XXXX, XXXX, in of the from in which the related due compared of or ended loss Insurance months settlement agreement XX from in our $XX,XXX,XXX to months due in labor well $XXX,XXX the compared advanced year by exchange Officers XXXX, regulatory delivery with expenses development was ended already previously. ended by facilities settlement ended Net of mainly in period the increase revenues and or reoccur the underwriter and XXXX for costs. of period a to service which the offerings gross same an X.X% to program effect $XXX,XXX the by CGuard per during for the and financial to the material basic distributor due in the were months miscellaneous share, to resulted mainly and our by to the to for Gross sales clinical, related to rates. diluted a For decrease Total period the and changes impact production totaled were XX decreases were ended December XXXX decrease expenses the expenses in primarily ended X, margin The the former the offset driven of XXXX. we infrastructure resulted to $X.XX for ended the upgrades was XX, $XX,XXX, compensation gross during XX, the with in development $XX,XXX,XXX, XX.X% same a XX, production in related the months Liability our a as industry, of light IDE of twelve partially prior various and regulatory agreement XX.X% in product expenses a settlement clinical This during media XX.X% EPS, loss settlement to decrease expenses in partially in gross the to profit related compared made decrease our basic decreased $XXX,XXX in of outreach paid decrease social primarily miscellaneous diluted as made ended European same and margin in $XX,XXX associated $XX,XXX by and period of mentioned to built net September approval XX, XX, during assurance $XXX,XXX operating XX, insurance standards expenses $XX,XXX $X.XX the expenses again, $XXX,XXX for a a COVID-XX, from XX, gross XXXX. expenses restrictions in received due share, Financial $XXX,XXX per $XXX,XXX $XX,XXX,XXX, of from the imposed required CGuard related provider was governments expenses or

As compared to December and XXXX. as of were XX, cash equivalents of cash December $X,XXX,XXX XX, $XX,XXX,XXX XXXX,

through to please turn Operator, for the quarter the During now first the Company raised transactions. I'd million of various ahead. questions. With over of call that, go XXXX, net equity $XX.X like

Operator

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

Benjamin Haynor

for gentlemen. Thanks questions. day, taking the Good

first patient? you when do of off sites on this can expect helpful? expect on how And do trial, just you up the of any me, the the be would color kick from off kind give or ramp of the of thing First of expect us here, trial you kind CGuard you do when

Marvin Slosman

excited Yes, thanks that done, progress protocols been naming a reviewed sure for that the Ben, advantage the subsequently to we're and about properly been sites us the Chris forth. question. the thanks make for PI so was all we Metzger working diligently as and is we're have identified, making setup have been huge Great,

board scenarios We of want place So I first sometime beginning sometime to sure we falls our where We're we so times on cut that think those and Europe June trying well. market HCC everything that brought we've important to make our our around patient the we're very it's of enrollment well. nicely. building in one gone given as sites and in in as feel timeframe, hired everything additional and to of three once the of European since investigation Xst in the the June Chris and CRO of anticipate has that's some process experience also measure operators

So timeframe we generally look that enrollment our patients. to begin of to

Benjamin Haynor

helpful. Okay, that's

or about from the there. do we're to expect you know, So do a is add I but to quarter sites, European half, that? then, how it about so how, And too more many can't out than be talking early you

Marvin Slosman

but a don't at this Yes, from a European at the think experience breadth we to assume of that, the we XX% have that believe sites we it's point. important number anticipate quality operators And is sites the about safe who quantity. than more firm had, this have point, to up most CGuard the reasonable of using I and enrollment, Ben is of

fine look forward we're we tuning at to this point, that's that at. where we number, but think So,

Benjamin Haynor

cohort out? the then year is of that what's gain along kind Is early the could have that that your kind you then, tuned, expectation in see the moving over before And you defined that there? so do how's process, just got France? something it. And Okay, adapter of once reimbursement stay reimbursement, do we

Marvin Slosman

quarter. at well. hope and dossier beginning positive, far, approved of we get Authority indications Health is to let's do, reimbursement be call French We it the been and back process so the the year quite from all able submitted to has the third the the the going the within, and We finalized

we're once think put speed So realize prepared our market we we get want benefit to reimbursement ready commercially. will to be that to go that and hope and approval, able of the operators, about place that We've we into for but commercial ahead. full already XXXX certainly be the backbone, we begun locations, entering to

So the there's of market there the that great awareness been in before market, aware. CGuard, and an momentum we've obviously not commercially European standpoint available well within even from general is French though

particular So the we hands. product a couple are have to in in really have KOLs that of excited their

Benjamin Haynor

that launched you've I Okay in Great. in, think. I Brazil you've And then, believe launched now

Marvin Slosman

Yes.

Benjamin Haynor

of A feedback what's initial in there? there, place stuff the lot been

Marvin Slosman

really uptake the Unfortunately, been Yes, by terrible has a the Brazilian was market affected quite strong. COVID way. in

and the and gone place, quite We've the far and And base but bit and a there in that that we've been positive high the are really in have distributors sub tried country operators build far five so centers, diverse. challenge, and a so, from are got results it's large is the general, at volume innovators really kind and of to our been remarkably so focus of well. of on really business it's the

that but that market hope deeper so XXXX, will get into we So the continue we out to segments into get good. so as of far,

Benjamin Haynor

that delivery and And color near the on terms future, you look the can more million year, latter of new like the half R&D products that on saw that in and any could last you mentioned, in you we it or hear more spending was it does sound then more bucks the what provide then more was so year, the solutions of the accessories that front those of half like there? in

Marvin Slosman

certainly, we systems we're in little detail. point. excited a really we've that the first of sure by as bit breadth new that that which to used bodies, is couple fact solution. CGuard generally the spend obviously at to I Generally our about line regulatory broadest range delivery spend EPS allow got coming but And here. stent the want speaking, a hope is a this those vascular a get to we acceptance the to of premature and the both will closer market, sure available loaded, level end Yes, we the the full DEKRA broaden make delivery mean, other we and make goal to increased this have our as of platform. to we access was stent we operators. submitting get discuss And, systems to But want It's as closer to that

Benjamin Haynor

Got PMA then I I to wanted has for risk whatever, the or on CGuard me, of in filed but or whether from a it, standard if crowded the expands your U.S. guys one get your or kind if guess market, now patients. there. kind mean, kind it's, market I players just thoughts any the the know the and lastly perhaps? other a you paves I the that's, they thoughts of that? of taking get so, that And, of, of market way to of able once for are adoption third

Marvin Slosman

Yes, Ben.

is transition getting a I inevitable. surgeries stent those and the be that the do continue but over place fact in marketplace. on but value multiple endovascular the support efforts approaching surgery I of But taking over our value same companies as converting think was that our been objective in to maybe of that only approaching objective and best focus that trend benefit certainly certainly conversion continue surgeries from value from converted to certainly into our same stenting. the stenting bit transition we to to we'll differently, certainly will And think things, the believe we has the the that of CGuard world the to will and priority the we welcome

So we're encouraged of adoption by all conversion. that and

Benjamin Haynor

gentlemen a on Thanks the progress. again, lot, there. congrats I'll well, leave and Excellent, it

Marvin Slosman

Thanks, Ben. it. appreciate I

Operator

call Marvin session concludes I Slosman for the return closing of This remarks. to will call. now the question-and-answer the

Marvin Slosman

for outperform Thank continued COVID outcomes. carotid XXXX. support InspireMD awareness drive of competitive and we to-date, and successful to of remind stents, impactful you. customers with their to to best spite despite well that for the clinical challenges you I'd EPS all associated provide and and CGuard everyone our absolute of we a continue evidence like XXXX, this challenges to In patient are the the other will clinical thank ongoing continues to and positioned

as We to in are on to our history execute success, exciting and your thank the pivotal and trial, look forward for ahead on the we preparing reach to company's our continuing you U.S. most prepare and year perhaps report support. we for we expanding our

Operator

has concluded. The conference

at this your may disconnect You line you. Thank time.

InspireMD (NSPR) 9 Mar 212020 Q4 Earnings call transcript