NSPR - Earnings call transcript Q1 2022

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Operator

Greetings and welcome to InspireMD First Quarter 2022 Earnings Call. [Operator Instructions] At this time, I’d like to turn the call over to your host, Chuck Padala, LifeSci Advisors. Thank you.

You may begin.

Chuck Padala

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

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

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

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

Marvin Slosman

France cases $X.XXX site, trial, X,XXX randomized the of QX our first XXXX with revenue initiating expanding of systems as our stent CGuard enrollment the for enabling sold sales commercial expanding C-Guardians keep in professionals, pace preparing in approximately and We quarter department approval received proved members global into world-class We including the markets, regulatory R&D FDA new for direct of added well to in our logistics with our more representing our to be our and XX including and as InspireMD a productive very accelerated busy European European CREST-X sales marketing first engineering growth. at UK hub, our to markets. sales prepared trial, our served team, enrollment seasoned for X and million. expansion direct programs and bolstering

with sales was better InspireMD foundationally $X.XXX order prevention, to revenue comprehensive standard stent-centric capture devices business focusing any convert approach, care mesh artery results compared a less than is a ever-expanding of as our are of Revenue more delivers with to and in CGuard currently of for can standard through strength surgery. this year-over-year price open sales million, its of size vascular dominated enable In proprietary this in this growth a Best reflecting emphasizing billion care more average further sustained It MicroNet other and superior By cartoid maintain unique design is short to this delivers and stroke approaching CGuard which and disease. on disease which The other all carotid outcomes, CGuard system top this the company. recognition. X,XXX protection enable sales specialties QX a priority to in sold. $X total invasive procedures distributor Our treating of indicator change establish line clinical we fully direct as and of market proportion carotid to stent term a and is this accurate the different unmatched artery we and global surgically for long addressable stent both the patency and market, a mission at our new volume to depend a to to in to endovascular-focused procedural note market market. approach endovascular the to our share make all we platform, markets ubiquitous partners, care results. stent on important to we addressing markets major patient units believe on XX% conversion patient

planning direct facilitate more accelerate hub will and European our market of during conversion Our a XXXX. for distribution

Turning IDE to enrollment the in trial. C-Guardians’ our FDA advancing

training enrolling accelerate site three there, with in Europe confidence continues enrollment with start and our CGuard. three plans plans and more site for Patient sites U.S., currently XX in with investigators, continues quarters. enrollment the with gained first next the with to expanded more Our during all experience in more along to two rapidly

trial Our current outlook of anticipating in QX remains the completion enrollment XXXX. consistent, the of

talks distributor believe an standard distribution We and less complement as partners with for offers dominated. our intervention the which opportunity surgically existing in would interested market for Japan in CGuard care representing as predominantly procedural Asian signed in We year. the continue agreement last CGuard, China of endovascular-focused

the community reporting, and for previous tool the will our growth and specialists our address as are to surgical encouraging. to shaft greater in been Both for short offering announced of we new stent for enabling broader as EPS. procedures commercial option designed the far, KOL our system, our change business CGuard evolving of transcarotid foundationally of development of endovascular navigation a pathway with will planned delivery set our a anatomy in has be with patient Prime, believe accessory thus greater devices available challenging platform transfemoral conversion be we a device, CGuard SwitchGuard compatible to facilitated As Thus well needs launch by versions and set group and in enthusiastic those CGuard performing Prime of to indications. to a landscape broadest CGuard clinical and procedures. from flexibility TCAR feedback standard CGuard XXXX the utilization early both will

tremendous rapidly With that, our set broader quarter call to first financials. a clinically chart Craig our potential outcomes mission patient the carotid EPS CGuard we to is to provide and with managed best I’ll proven prevented are system, new and over to of unlock how this stenosis is market our tools strokes evolving segment. and turn growing this Craig? the As how of in course review

Craig Shore

during for XXXX. This the driven $X,XXX,XXX sales in of EPS CGuard quarter increase predominantly the was a of to increased XX% increase For year the revenue to XX% to first quarter the well from by post-COVID-XX ago from million in million in XXXX. of increase returning first a of This sales $X.XXX X $XXX,XXX mainly XXXX, as hospitals quarter as in growth markets period $X.XXX the volume environment. same from new million existing demand due and was first

compared countries, CGuard addition, profit $X.X due of number. If reported million, in was margin quarter reported XXXX for we do the issues. of first restrictions, expenses period. related an XX.X% In March compared supply Total countries increase used driven in stents profit the three XXXX. due $X.X the loss and not FDA the FDA eliminate in in increase $X.X conflict the we growth the during were the diluted U.S. million a write-offs, for these sell were would XX, for $X.X Ukraine mainly have prior per per XXXX. quarter for period first $XXX,XXX basic in or totaled of been share first the was first impact the commencement same the XX% XX.X% ongoing trial. versus Gross to increase during operating to primarily XXXX, to to Due of sales by quarter currency diluted of EPS component XXXX limiting growth. resulted the Belarus increased This gross a which gross study to compared from to and the X to decreases increased our basic loss expenses a clinical $XX,XXX Russia, Net in share-based for these XX% QX, during the of ended versus XXXX. there compensation. to of This net or share year C-Guardian to C-Guardian for of $X.XX $XXX,XXX year-over-year and million by profit a XXXX increases first quarter $X.XX Gross $X.X million of and quarter in the million and related of months

March over XX, now of $XX.X XXXX, I’d to cash December deposits XX, were equivalents for As call million XXXX. $XX as the like and turn questions. short-term to operator bank the of to million compared cash,

Operator

comes question line Ben [Operator question. the from Please your Haynor of with Our with you. proceed Global Alliance Thank Instructions] Partners. first

Ben Haynor

Good moving seems things congrats morning, the for like on the gentlemen. nicely. are and taking question Thanks along progress. It

investigator co-principal in doing he wondering cadence cases past. be to been CGuard in I to prolific or his Dr. the know Poland, similar I pretty have was the like has someone you on Now Metzger in case slower? if that you expect slightly

Marvin Slosman

ours And carotid the probably in for Professor any the that of certainly and will of physicians world. be procedures we to top trial Yes. quite anyone contribution of with thanks the he world. of time, volume Piotr his stenting Hi, been CGuard question. believe referring on with par and the to, the Musialek in has you’re some most Ben, KOL a experience person the has for the is

in in about the we’re Professor a he’ll also incremental as co-PI in investigators involved So and enthusiastic Europe our be driving effort general, with there. incredibly leading being Musialek enrollment

Ben Haynor

Okay, to already Europe are kind first? in that great. what and go then ones know direct on on What intend of in hub list? guys conversion direct but a And agreement direct you the distribution do to countries the the you I you’re signed. France, next

Marvin Slosman

Yes.

it’s the and of process direct the in the both. fine-tuning we’re And – France on now, Ben, the we’re countries. right in So other details UK

in imagine, can that in areas. we those have given the many distribution bit fact you place sensitive it’s As agreements a of

this products details higher regulatory basis, space logistics the able a in calls. a a in first advantage want the make on that in, position we model the is a subsequent So But to we’re now, be to on and put engage the and hub the that sell much effort be take through in will calls. a get and much it sure with the of control are working basis. more to efficiently on pipeline, on much doing a perspective direct direct our that subsequent from control topic direct to number to plan There ASP countries more more information of certainly step sure make new market was that of we’re but we in cleared but to

Ben Haynor

Okay.

So, stay tuned there.

Marvin Slosman

Yes.

Ben Haynor

that forget I first in did enrollment do guys? think cases? that And the where done you if exactly the be in then I available have the arm? stands trial the trial prepared correctly many CREST-X stent in And cases hear remarks so, are you on the and to how you you might

Marvin Slosman

Yes.

considerable a in now. done We is out. amount right to there of are Obviously, preparing first logistics be to paperwork be for sorted cases

arm sites. the to trial. That been for working milestone of diligently participate in locations CREST-X right lined executive We to are we committee been have thrilled And the get C-Guardians current huge us. CREST-X a to the some are approved which have up, stenting the was of with

more in we moment, that we right quarter have the the that CGuard hopefully, much And those share we view at operators are you on so we we for now, of sites. arm. stenting number firm detail preparing but certainly can those interested a during a But and refreshed enrollments, the will And have that in don’t being is bringing think to contributing detail.

believe will So, enrollment. help that considerably effort in we CREST-X with the the

Ben Haynor

don’t that have any that the better I That’s I on And of sense arm you that? What Okay. have And know other stenting arm any that behind what decent helpful. guys there. heard color – additional thought progressing? amount how on information, do – the then but had there, is a CA trial guys have I you if was you

Marvin Slosman

the make I don’t we that, have specific to point. any at specific have robust. details CGuard continues side and Ben. at we for number available – But share. of you can similar this a enrollment, don’t provoke that We We feedback, to have But being point. measure but certainly more with have hope the don’t quantitative don’t, that that we a this stenting We enrollment heard

Ben Haynor

just fair Dr. stenting for CMS may guys there kind in of reviewing determination to event, on Okay. anything front that match you was heard? of coverage then of kind both been to have the kind in think CA. have made of Dr. the suggesting likely more expand back and and your national That’s that Metzger And statements enough. Is I that coverage near-term on of kind process Lyden the KOL

Marvin Slosman

the for of except stenting and that hope does We obviously, details, encouraged us. more risk. trend that of And the of here. certainly any be a we have by the would contribute And are side all approach. the don’t to cover to those We effort milestone supportive endovascular then and tremendous that business standard begin CMS

the of to that encouraged by on have any that huge than don’t again, progress. are, try enable the continue and a we We uplift, other are for support So, to all general. would details we for and industry-wide space in be the obviously, that efforts to us change going

Ben Haynor

then And all that And decision for submission plan driven you sure. and fun I to me, those development do that on in what then on direct lastly A regarding go deal Prime and remain just products? And CGuard geographies stuff? big for guess the what and activities first? SwitchGuard by partially is launching

Marvin Slosman

Ben. absolutely, Yes,

Right I momentum. into on of got the get regulatory are R&D right direct new think advantage data and these what to is the you we many our call fact in that pipeline take by the stage there. of required the we now, and and driven getting pathway. countries we all effort certainly we launch, getting well of the are to have clinical want products products And full V&V to the that into that through

manner. and of to So, have approvals all place timely in take our continue hope that a those is to effort

tremendous and about different of as incredibly approach. of of what play fundamentally that perspective, to a quality interested as much a basis frankly, in surgeons. really those well offer And CGuard both a the business. importantly, broader products, how comprehensive QX that’s base a the of they we outcomes stenting most are our is stent business. comprehensive this life both enthusiastic and anticipating see the goal from a approach because of stent we And the ultimate to both the vascular to are is matters. and patient as physicians interventionalists We access about is We is approach clinical the launch That

those XXXX. the and So, forward we delivery are in really to in looking available systems having pipeline

Ben Haynor

progress I all had. the gentlemen. and That’s Great Excellent. congrats on update

Marvin Slosman

Ben. Thanks

Operator

are further like closing in over call to no to Marvin the back Slosman queue. remarks. There the would I hand for questions

Marvin Slosman

and support. I the thank you. Thank everyone would today for the for like call time join to taking ongoing the to

proud progress breakthrough the from a extremely year and are InspireMD. We for look XXXX the quarter being to of forward

Operator

teleconference. today’s gentlemen, Ladies for conclude your this does you participation. and Thank

have wonderful disconnect your lines day. may time, and You at a this

InspireMD (NSPR) 10 May 222022 Q1 Earnings call transcript