Earnings call transcript Q2 2023

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Operator

Good morning, and welcome to the InspireMD Second Quarter 2023 Earnings Call. Currently all participants are in a listen-only mode. [Operator Instructions] After today’s presentation there will be opportunity to ask questions. [Operator Instruction] Please note, this conference is being recorded.

I will now turn the conference over to Glenn Garmont with LifeSci Advisors. you. Thank

begin. may You

Glenn Garmont

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

Officer. InspireMD Slosman, Joining are today from Chief us Executive Marvin

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

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

The of time-sensitive after reflect by to as information revise is today, as this accurate InspireMD any August publicly disclaims call only required information that occur except obligation or circumstances any or law, XXXX, contains call. that update events X, to

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

Marvin Slosman

of of to everyone that you, I'm with solutions our advanced and the morning. CGuard revascularization our the lead a stent carotid our pleased foundation time to carotid proved built Thank market call next-generation company Glenn, second this joining for as we be to thanks platform. on quarter transformational XXXX our share for mission the to

to generated quarter million quarter in financing nearly system the highest up $XXX.X revenue date, The to of capital. total for XXXX. to the as Specific revenue first XX% second date sequential stent representing second growth and quarterly CGuard well XX% of CGuard XXXX the our of produced as our growth of $X.XXX over quarter our carotid successful revenue we our to of over of financials, new highest million,

acceleration the growing to of quarter volume to performance we volume as our X,XXX territories Foundationally, XXXX. and and second quarterly during the and first a have quarter success key during Mark on of experience We of X,XXX sold the continue measuring This the XXXX focus our during stent more to and record quarter metrics as stent systems of established and CGuard date. Procedural data be compared utilization. XXXX sold the market EPS continues share. to we approved best-in-class XX,XXX real-world than use of reflects with CGuard CE baseline unit

awareness drive will implant and As the expansion, we performance our remain of global focus. market cornerstone

of upon prespecified up completion placement the with to an to the $XX.X million trading with warrants of for milestones achievement million XX the tied $XX.X The by days $XX.X following. transaction or of tranches million, X issuance the are May each. private a in milestones warrants of financing additional announced to $XXX.X expiring million We following closing tied of followed

CGuard The and commercial value receipt the of for the the secondary quarters system CGuard of the first approval carotid systems. specialist serve -- fuels of the X-year of our C-Guardians plan a broadest tranche delivery plans SwitchGuard system Wace, ADCM significance to the endpoints validation to in as health pivotal OrbiMed, tier our neuroprotection by completion Receipt artery through approval It and growth leadership disease our this Velan business Prime We of release of primary and States. X of stent CGuard system, United Prime of FDA study is tied from to to premarket XXX for trial. results of follow-up related investors, FDA and of direction. a stent transcarotid with and carotid Rosalind, world's offering company care of treating of market top and recapitalization the of of Nantahala most some community advancement long-term complete our strategy Soleus, neuroprotection Marshall sales including

transcarotid and CAS transfemoral both offering and developing neuroprotection company systems. only the As

the with optimization foundation we focus way of the to on a business, approach. our forms lead this results best by and implant look the the procedural to Prioritizing market catalyst clinical of as comprehensive

of now enrollment of to of day carotid and clinical CGuard a is of X the enrolled and IDE EPS for the to The recently, support ipsilateral C-Guardians infarction announced U.S. in on safety eventual to at trial, of system The FDA XX completion a and Shifting the clinical evaluate trial, across XX stent in death which our is the primary we incidence the our stent CGuard endpoint programs. patients composite to the follow-up. of Most trial's from stroke XX the myocardial in is approval days artery objective system efficacy XXX in United Europe the stenosis. States. of Prime stroke designed carotid treatment updates which centers X-year

activities advanced in features our trackability XXXX, increase CGuard half pathway. of anticipation to the United stand novel who this time a C-Guardians planned offering pre-commercial results we in the the approval approval of in just the include EPS was to benefit to a XX approval of to submission broadly United in CGuard line in launching the the lines Enrollment first in to of States half delivery and CGuard system, acceptable to premarket build-out the XXXX. with initiated in those make also of cash of sight the completed treated have successfully months, Prime functional and in includes patients States stenting in of technology. and ease next the and half If of achieve our regulatory year. deployment is anticipate from we we with first which Prime next-generation results team potential available world-class the that improvements cases Notably, CGuard included trial the first-in-human stent In included infrastructure second

and both good expanded stenting, expansion -- clinical both July, first access and to very demonstrated of are the By This procedures market update coverage be on our whether adds for patients date, to and shift an high symptomatic a endovascular CAS to integral issued coverage best-in-class results over EPS this decision in a U.S. for This symptomatic memo has finalized market or peer-reviewed CGuard towards patients, Prime for surgery. risk to considered drivers expected addressable options proposed performed would Broader real-world be meaningful for in of CGuard of optimizing which patients, for of cash superior a way is and TCAR, is our and X,XXX enthusiasm, for CMS with coverage standard foundation approved, approach. for stenting, if the XX,XXX procedural strategy. sales both cash part and rigorous market represent decision to studied of results. October results. further trials for recommending opportunity over an establishing

remains our expansion of endovascular approach performance surgery implant, as leverage shift some and we've an toward our reimbursement driver of remain away potential trends consistent for proprietary will This which from with our MicroNet the the of we as story stent outcomes advocated first The of cornerstone clinical next-generation priority remains fit the time. CGuard evidence the mesh.

Turning now to quarter. the

As is Shore, recent will in our I quarterly Chief from procedure, Craig now financials the recovering Officer, Financial detail. cover medical a

This sequential For second mid-February, the million revenue includes of second approximately temporary for CGuard with was the X.X% first of XXXX. quarter by a ended over Prime XXXX XXXX, impacted quarter and of our a a over we XXXX backlog generated the increase of quarter first of of negatively $XX,XXX $XXX,XXX. XX% growth revenue. QX and million, of quarter our total we $X.XXX the of CGuard as that product suspension until CE revenue Recall result, approximately mark $X.XXX

ended ended months $XXX,XXX months by XX, June X during X profit $XX,XXX the gross to $XXX,XXX For XXXX, the June first from XX, increased or XX% XXXX.

less XXXX, ended XX.X% the increase ended This X profit gross during driven XX.X% labor increase profit in as June the X mentioned during above. XXXX, offset by related mentioned a associated XX, Gross material the and from percentage by increased in a from of June revenue XX, expenses. $XX,XXX margin, to $XX,XXX factors and the gross months resulted months in miscellaneous before, as revenue,

grants operating second $X.XXX expenses in for expenses America recognition legal VP and Global in the an Marketing expense the of second expenses. to or made for in Total of of $XXX,XXX increase during million due the primarily and This the to quarter expenses compensation-related salary increase second million, and to quarter share-based of $X.XXX quarter hiring XXXX. increase of of XXXX General are X.X% the North to increases XX% for mainly due compared increase XXXX, was of Manager

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

of we and the equivalents of of upfront and cash of This expenses that cash, deposits compared approximately bank pursuant million securities received XX, financing short-term earlier. million XXXX, May, as the to were payment XX, I net discussed to terms an that includes $XX.X XXXX. $XX marketable in June transformational million December private $XX.X of As

will now questions. personal turn we back my concludes This for it remarks, and Operator?

Operator

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

Adam Maeder

a In congrats nice versus go a on bit of U.S., share wanted the I kind maybe just of Craig, as start, a little just deeper And to little like catch-up outside understand quarter wishing Marvin, sounds better speed drove of bit performance recovery. better the the there's Maybe progress. It you on what the well. to market capture dynamics.

I bit the but of out then So in And go know just provide year. half on guidance any just on broad the the lump I public part there you just the domain, have deeper don't wanted color question the little or on can QX, second back and a to of results. that the I'll QX you strokes QX

Marvin Slosman

on Adam, the call, for thanks for being question. and thanks the

there day. I of field referenced payoff in and backlog. the be partners. terms in As just being think for you our strategy this a general, our the We're it was investment transition distributor catch-up there, that in our relates customers think to marketplace. of I in day to stenting lot our of continues But Europe, continues focus a carotid and strength And to grow, market as to us bit in that able working is with to a

to Now continue through to drive cadence utilization the of that our MDR work operating the we kind have we're back normal field. scenario, MDD, worked in and and way

think touch know, group I and a continuing of and just distributors on very a This is you we're a a and to business, good assembled team, we've day-to-day great as basis. execute

was we I example, conference a It for to continues the market think in two and the live well-attended create awareness to we continue year, conference. at So strengthen, cases. Leipzig, this had LINC

that I think, the IDE exposure work the trial us U.S. in does as in helps speaking, so generally our And

really vascular a specialists. as to environment global it do So relates in we operate

those in results, we're with so continue pleased to invest And and really we'll area. that

it European to definitely There But we seasonal QX. question, your all QX on is our to European way, and -- the and will think our and strengthen share the advance we to predict tend as continue relates that that impact and numbers our grow build business a is market. to relates the in for I things market. QX by expectation As for served it balance, and

well. markets, XX just South Europe, America it's not as in So but

Adam Maeder

have the How do think And just for And from your the NCD is the memo? you. implications is just the States, next key question United kind bigger-picture, around here the your that proposed open-ended finalized. in of I are for broader a business? takeaways What you about question market

Marvin Slosman

Yes.

certainly So question and contemporary that discussing. it's great topic a a we're all

proposed decision, the is that good and believe coverage we for patients. foremost, first First,

think catalyst that's with platform this alternative of set everything patients benefit the is discussion of business technology haven't this better as else, we And their from better clearly, think of to with marketplace. a building yield coverage options, believe intended that and to that broadest changing broadening been opening delivery care procedural in I So physicians otherwise be and we outcomes we're above decisions I implant available best a the good. and options the for will around standard

October. of balance, see to many this we're to as what timing full memo to a years, as and just carotid of we've the this for a as decision proposed So I the whole. this we able market in unfold, for we final perfectly coverage continues decision demonstrate certainly on direction as that And think outcomes. look this in really think and suited we great we've support patient helps the this terms take and to space and decision transition forward poised advantage CGuard is in been invested But

building and we're it. here business So really the around energized by direction our

Adam Maeder

the there, TCAR I a more, of to I regulatory if U.S. the just commercial the couple understand looks as wanted wanted lines well SwitchGuard to time kind and pathway about what And may. ask Europe in better system, both strategy as next like.

the in color crystal it's particular. on what think get clear of today, TCAR lines wanted about bit more time terms to I for a you've little I in CGuard system, talked just but

Marvin Slosman

Yes.

work our at a will for this regulatory the effort. stunning it pathway point, we're guidance I following by this advance protocoled be certainly system that that So we're from Right characterize we continue in and to determined which would area. sort looking now, a Adam, approach, way, regulatory of following

And looking so I the market a access, both develop forward U.S. very interesting that Europe studying been system to we've and in to think able in and real in are

And that we're looking as the and some the touches to of overall of of for specific so be work bit finalize sort direction. we that, able regulatory I in pathway, clarity FDA in we'll just We're as time a to some feedback. with the overall this there's terms lines. just quarter on detail of provide last meeting protocol through think to relates still it more But

in a form. So we positive, and that's can we this hope study practical to that, begin

Adam Maeder

SwitchGuard subsequent TCAR want system, CGAR launch future to speaking, XXXX. just not-too-distant after or is TCAR United talked too it I the product. And that not right, assume first you -- in about States but half come quarters broadly the make commercial lines, potential of to in the the sure, could reasonable much for have the depressed that in time here, And just

Marvin Slosman

Yes.

So great.

topic. waiting able the the then run good the a remains itself question, system system FDA concurrent short that that of studying the system from take we Adam. to things final this of device able itself, same. our CGuard have and all stent to And concurrent device is approval approval and shaft same our for it's with stent to a the concurrent again, on the feedback stent the is being the process stent will sort as close and be our approval of we're SwitchGuard, with study approval expectation or equal. itself we'll So Obviously, system be TCAR and on very but TCAR the But to

time. a able we'll that the that to or And hopeful so parlay on quick about we're process same be both approval into fairly for

Adam Maeder

me. then And just question one for last

you're Just U.S., bit on in the how maybe little prepared. to you getting go-to-market speak the strategy a of can kind

about You pre-commercial prepared talked activities remarks. in the

on kind that that, ahead the about and line. first sales are how And of 'XX of out elaborate Just a infrastructure thinking kind team please? of building half you time

Marvin Slosman

problem. no sure, So

was a organization U.S. a for So about our hired Shane first to the we structure of of step the architecting X VP months Gleason support And and U.S. business the in as run ago, Marketing. sequence the that sales and plan Global in direct

the how And put beginning so this has strategy. well think taken both challenge it's Shane both well as serve support organization our But the world-class go-to-market operationally plan safe subspecialties of and that to structure within to a as building on ability enterprise and I to in assume and pieces, that to we'll place as interventional. sales we're build community, surgeons as multiple the vascular going all

a to over a we're point plan here able create But launch. in And get is so where months that that out, invest next whole with continue to and in of approval think that's I to and we're this warm can so XX the a just we until lead-in as tailwind NCD to full building have point a we'll take we start the the and and the whole. advantage very U.S., our overall created been for both stenting process

a forward leveraging we're experience to strong and So our parlaying into that U.S. launch. looking European

Operator

Global Alliance ahead. Partners. comes from Haynor the Please question line Benjamin with next of Our go

Benjamin Haynor

like got coming What's activities. quarters in kind reach everything but be take quarter, coming the team that, going that to is up, are until got FDA of management of the moving your C-Guardians What beyond focus? and C-Guardians out? Now focused most precommercial you've enrollment up you this the on mean most it going the to well. you've wrapped I seems along meeting

Marvin Slosman

thanks Ben, the for question.

goal amount work, tremendous us order accomplish a as to there's in in related on So you of approval XXXX. to know, executing for PMA the that

So certainly the own hard PMA get the amount we're a sure to tremendous all enrollment working to pathway is approval, in is context to its now that regulatory team the the steps as work that SwitchGuard well. of is complete, necessary of following studying make

strategy finally, managing growth Europe. our and then and just plan in maintaining And

characterize funds in It's accomplished. forth. that much going able executing milestones putting about all down way. financing would this to mode we've And been been on our and we've heads forward. I our it in has good now that execution We're So very these set secure

pretty think this these can and clear so at commitments. on a we pathway making that it's meet I we is but point, these sure easy, all successfully focused that all variables nothing we're manage

Benjamin Haynor

plans outside to go here. mentioned And internationally, any to place commercial take of direct then U.S. the that any organization kind the you changes

Marvin Slosman

at I Ben, discussed think Yes, we've this length.

and one making moment. keep much try for strategy We pretty But toward strategy going. of the what evaluate international figure want current any best our growth stable the the every that. our the continue to the go-to-market certainly go-to-market immediate markets and U.S. in is to changes to shifts in of We out for terms momentum outside were

it's in to accomplish. and think small is in to best a in us front the U.S. many I building tasks focus the test are of organization, a of our that attention our not interest which to related direct

So been want kind leadership U.S. next partners in get distract to I ourselves under successful we we've to growth. from distributor that and of launch. cadence a our months' stabilize to don't Europe for the great maintain effort able And think XX

Benjamin Haynor

that is I of complete recertification, in it That certainly Is didn't CE makes for will notified sounds of MDR. kind the everything sense. maybe the the And at? review And by catch and kind correct? But you're this where you're like that on document get then just correctly. Mark body that

Marvin Slosman

European midst the touches of of of seemed correct, life body, We we've system their all document it's by as own, which the review clear all actually a take expect were review, with this that's come given of sort final to But it Ben. ability the to weeks. process. within for to that shape in and health continue shape Yes, those to sell notified as think MDR our that we officially in under ship good coming be I -- and certification relates formalized in we're to we're good MDR the expect the in there in April. MDD Europe, and But the in to reestablished our

Benjamin Haynor

lastly transaction you with miscellaneous maybe G&A, a those? I that things the legal question. know, about more and you quarter? unless to what's or of so housekeeping the had again, expenses for $XXX,XXX then the Or On recur way me, to right think those expenses. not Are that And expect don't of associated during

Marvin Slosman

So actually, and Kohen maybe VP with Senior question absence is that in of let is who Amir if us the address of that's today, okay. Finance, Amir our with Craig us being I'll

Amir Kohen

fundraising, there last There some so it's to to from year, cetera. it's from and Half expensing transaction and is including shareholders noncash I nonrecurring in is think legal expenses. prepaid compensation after increase -- it's it the expenses et letters, ground increase relates we a some of and actually do had specific so

Marvin Slosman

Okay.

calculated as raise. answer, the our last and Ben, fund that through nonrecurring year through is it's as So simple those well both were

for set we're that. So

Operator

would to back This to any Marvin closing remarks. Slosman Marvin? over concludes turn I our session. conference for the question-and-answer like

Marvin Slosman

Yes. time for the encouraged being Thanks look very and again for call our balance into successful for everyone year InspireMD. of very for Thanks the joining to XXXX we're and progress joining. today, the by forward

InspireMD (NSPR) 8 Aug 232023 Q2 Earnings call transcript