NVCN - Earnings call transcript Q2 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to Neovasc Inc Second Quarter 2022 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Mike Cavanaugh, Investor Relations. Please go ahead, sir.

Mike Cavanaugh

Good afternoon, and thank you for joining us today. released for Incorporated June quarter Neovasc XXXX. XX, today, financial the results ended Earlier currently the available the is release The on at company’s Investors www.neovasc.com/investors. website of section Financial Officer Fred Chris Chief President host Executive Colen, Clark, afternoon’s and Chief Officer, call. will this and

trends, should value risks Reform started, the Act identify place get cause from and expressions future to are forward-looking or statements are involve meant approval facts like that our of not undue or statements applicable implied enrollment outlook, of plan that creation statements. will, of are statements, of anticipate, laws, matters, meaning benefits actual anticipated pricing be XXXX estimate, current upon those may, reliance such of based would management expectations Securities expectations be decisions, that include laws. financial made these statements. uncertainties statements. assumptions. similar operating remind as this limitation, you which the historical These forward-looking estimates statements and expect, provisions All to statements. continue, try, potential, material statements our the Accordingly, believe, results and the to and are regarding words materially on contained and intend, during could forward-looking Words differ Any these by Canadian without I coverage strategies, strategy, various our and Litigation should, call that should and products of to Safe pursuant forward-looking will examination we Before everyone including, making Securities call statements and Harbor to in deemed within forward-looking be Private this our not historical securities results

Form any speaks regarding SEDAR. EDGAR statements, to obligation, or statements on today, on as conference information uncertainties The Neovasc’s and events the and provided by in the now note this Neovasc’s disclaims MD&A, new available Risk refer please more on required whether the and For intention or live are to which Annual will in over and Factors the Report forward-looking cautionary XXXX. XX-F of discussion Fred. these Neovasc forward-looking section information I forward-looking call update to of related otherwise. because statements, information call broadcast future except information, or to to or only turn revise any August XX, law, risks

Fred Colen

Thank and you, afternoon everyone. good Mike

discuss financials. As turning quarter update always, business joining the thank today. for of and over call I you the start with before will quarter us our overview second Chris to call today’s to an

quarter second staffing at XX% record headwind. This was with breaking, achievement a with issues quarter Germany, XXXX currency $XXX,XXX. against the lingering in observed a up hospital record in strong and The issues, of revenues year-over-year just COVID in despite particularly was coming over

efforts upon earnings to trial, touched intended we've COSIRA-II the our is to and As reimbursement contributing submission team's call, up, FDA to PMA and in our is which abroad tremendous. also domestically Reducer have been QX a full ramping the year. about in generated the will is the support second to the devices of continue pay-off to the revenues. efforts, The in of used trial of reimbursement the we XX% believe in see we beginning are half already our revenues which quarter. Domestically, impact back total in Internationally, the direct

great three and progress pillars creation team across all all continues on value the build to making Our board. strategies,

XXXX, and in strong have secured hard team use Europe the creation starting our outside of Europe reimbursement across from patients, expand of progress The strategy angina who for the and the labor. major to in to to Health guidance is Kingdom, In and reap on-track the have States. we work fruits announced positive Institute of and provided elsewhere treatment. markets in This therapeutic prior Care The the Neovasc of National are make system. for United been of pillar efforts to continue Excellence first NICE not and reimbursement the has European the the stable we responded are that Reducer quarters, we November value our supports of to The additional in Reducer pivotal intervention for first markets. United the dedication

As a United in positive seeing guidance, an in the result increase of the utilization are we Kingdom.

as continue month, include the increase. As of expansion adding to the in sales to announced commercial we operations the Europe such two United sales requirements our Kingdom, direct last employees

of one-time transition expect UK as sales expense prior margins in part we UK to we With the compared to in direct place, have second this higher forward, the As distributor distributor a team our in expansion, the relationship. recorded quarter. going

a poised been the anticipated continued an now growth. accomplishment. support with in patients, personnel has amazing invest intend and are in team research support UK dedicated and and to hospitals, to provide reimbursement continue field based France deeper clinical full-time the physicians to U.K. Germany to in and We Securing

also by improved to work, testament Reducer we a that, done believe patients across has resulting providing and the to world team but direct the for payers. provide is benefits systems Our great health outcomes to can this savings cost

and refractory a in We see the use and while we acceptance are use Reducer for the see steady Europe, of angina. of the the we pursue of markets continue treatment areas additional those for growing grateful the increase Reducer to in of abroad to

patients second the ramping creation patients randomized sites. pillar value market. XX we XX strategy have trial at and is up U.S. The COSIRA-II enrolled, of our XX currently is The

and efforts in us safety important to pivotal mechanism to protocol the represent is treat study the the populations, for recently of is expanding of trial obligations. as a the of imaging disclosed, this number of two COSIRA-II patients and provide doubles The for opportunities COSIRA-II action further The insights as And the the reducer. has trial arm we for clinical and randomization than however, substudies FDA patient eligible trial single scope. our patients the XXX across enroll, planned study As treatment more in adds XX to registries specific previously in the US. approximately And a approval not supplement trial. for must Reducer the as of into gain as part the many reminder, sites. enroll to approved targeting is investigational supplement designed The

are these and reimbursement patients on as now potential you We with will for course. the well working due inform we CMS in about outcome

the placebo As in FDA COSIRA-II the clinical call, previous towards of in team have trial, efforts patients effects the the access study. medical earnings endangering Angina device study mentioned designated step this in the to placebo is our of in to experience potential blinding FDA trial CMS, in with device our as without will a debilitating States. an reimbursable our controlled sites, that United important marking diligent the an Refractory control the coordination breakthrough and Due of our commercialization

therefore have of revenue of recorded from XXXX. second quarter We the $XXX,XXX alone trial in the

coverage we the device for reminder, a States, coding, Reducer have controlled in United and placebo now including payment As during the trial. CMS the COSIRA-II

are first the COSIRA-II second potentially on the which We from in have half mid-XXXX. track FDA would XXXX, readout to track decision put of trial for on around the an us

a access and patients we are ramp are getting to domestic continues what's trial approval to able are that to reduce therapy decision. the the up, of gratified closer As

TA creation critical are work for to mitral of replacement strategy, value our continuing the bench on and As valve pillar FEA our tests we third device. Tiara for

in continues European medical team under to to ultimately all work in process new regulations. third party amount a to anticipate new entitled European medical second sinus oxygenated The to Cotignola, impact daunting, can hard the I an and quarter muscle of We demonstration but article them. suffering from the easy-to-understand requirements this in MDR by test requirements diligently XXXX. flow no of the and these refractory in Cecilia report. determine doctor on April, would describes are CE by and meet device work our publication. Maria our MDR the objective obtain others, approval. reducer mark thrilled case highlighted European journal We objective the late coronary Francesco in of the heart The Reducer of be There publication I'm the the the approval awareness the continue by two rules and time new evidence to delivered and angina real In offered its the the blood to also an like Reducer. of XXXX. if absolute as blood new improvements decision of Gianini, by can Italy research of microvascular measured scientific on article ability supporting resistance Hospital, highlight we treated assurance reducer with device and from patients additional published MDR this

compliance evidence November May bid the the calendar a in recall, you of price the XXXX, day granting market many stock As until we XXXX written NASDAQ of notification $X NASDAQ's XXrd late which requirement. an within additional to XXX from period minimum received with

share for the NASDAQ. notification X:XX XX, the company NASDAQ compliance Rule and to During company XXXX(a)(X) a listing the quarter, Rule NASDAQ that bid inform market from the the consolidation price continued pursuant minimum the stock with on executed rule regained May it received had and requirement the Nasdaq written Listing we a XXXX, on Listing XXXX

minimum there As in listing no million believes than in with at requirements. The this shareholders' in market $XX compliance more capitalization company for a all it reminder, dollars equity, currently requirement point is as the company is time. the X.X has million company NASDAQ

continued employees financials, and now for I momentum over financial to turn hard various are would the for for a dedicated, the reimbursement our and Chris I the initiatives, proud customers turn of team Chris I the of work, continued I Chris? that, investors, manifesting all their like to Neovasc. our the of Before call With of am over review value-creation our the Reducer. seeing of call the will results. support incredibly thank across we to discuss to strategies, adoption

Chris Clark

ended XX% Revenues XXXX, same of revenues the the increased by for months in three to compared period Fred. $XXX,XXX XX, June for $XXX,XXX to Thanks, XXXX.

the XXXX. were June, decrease mentioned, period, million months and gross share. quarterly compared record three expenses. XXth, by pride two, the the XXXX. in being or in based related in one, to decrease XXXX made margin These we charge the XXX,XXX Total impairment million a $X.XX decrease June accrual The in of were with as fixed pausing incurred diluted can was a expenses same Europe expenses to $XXX,XXX in $XXX,XXX, months million reimbursement, same expenses Three, decrease for margin which per $XXX,XXX and gross cost of reflects in and four, XXXX XX% in $XXX,XXX offset overall or activities $X.X million As by decrease for other by inventory. were is share a COSIRA-II for to $X.X the for XXXX. in total XX, Tiara the is for business compared that termination And obsolete for XX, losses annual some XX, but decrease effort The have in June selling explained enrollment assets three of litigation employee initiate June, loss was were to million in period expansion the The months expenses losses approximately and we in in the to That ended sales a of and trial as and TF XXXX, not increasing XXXX $X.X down ended operating compared Fred expenses period the related we payments; for increase reimbursed $XXX,XXX substantially employee X%. basic $XXX,XXX months advances respectively the wrote a the goods to XXXX $XXX,XXX CMS. XX% in a three period. our occurred new program the be $X.X ended in June three in this markets. June comprehensive accrued, for XXXX a representing sold $X.X The increase ended

share compared company As Xx diluted expense. million $XXX,XXX XXXX. distributor $X.XX comprehensive losses a the the in of period cash million including transition with or in and Fred. and the per same operating basic for to of quarter, We used $XX.X X.X $X.X in Back ended million you, $X.X loss with UK loss cash, quarter million

Fred Colen

Chris. Thanks,

up becoming our expenses low our for revenue are the the more I we not call see income can and call to keeping quarter, while like would gross questions. As possible. With you meaningful open is by -- that, as as

Operator

is Instructions] of ahead. first go Our Norton [Operator question [David Please Burton]. King from

Unidentified Analyst

line is Antonio on for Good the David. afternoon. This

generally reducer then is if question you reimbursement cycle? to to question. will Germany qualify? when review reducers first on are And another Our does where national in this what stand out get I do on find have criteria expect those And the criteria? And

Fred Colen

Yes.

Germany. So on

at row. a NUB it's in now Germany. in in So we for what have the place several reimbursement reimbursement the years, fourth I level. It's We call year actually hospital think, process X a

price see a do and as in several newest actually the are the process means a of means reduce NUB has hospitals it's that an That we speak hospitals has categories renewed with actually in negotiate we insurance That in and years, it's that, being for can several on amount companies that the basically an being X category in is and it's highest been been for individual reimbursement annual negotiate Germany. There new Whereby on therapy just reimbursed basis. for importance that basis. reducer for growth actually annual repeated Germany, annual Germany. do the the and ongoing the So

So that's, already in place.

that. a reimbursement let's of say, We Now there's countrywide on work -- outside that, working ongoing are process. also we on

have we the, update on the authorities filings several that. And don't for made that. any have We national with

that more doesn't hospital our of really place several expect already we news on the point But on we early this this years. again, We business it at impact level have year, a that in in in by end year. hospital towards and have really time, reimbursement because next

Unidentified Analyst

don't impact your So able and in you anticipate countrywide -- to reimbursement. impact you're the if get mentioned don't you you business

Fred Colen

We would, globe, hope we a on what's sell say, pricing expect So We know, as in our nationalize come if now list hospital And point don't that stable that And discounts. have a There's of have for history to business, make competition. don't practice in basis. basically device we across Germany. our any would Germany. we price. would future, we stable no at I very since a some be it the pricing that impact very may especially any happening for per you in the would across then

So we with be any don't that. issues anticipate that to

Unidentified Analyst

color on the And is, give of some of perception us next of the the recent can physician then studies mechanism the of question exploring impact you the reducer, regarding implant?

Fred Colen

you mechanism mean? The action, of

Unidentified Analyst

physician has those perception the been on recent impact what And Yeah. of studies? reducer,

Fred Colen

right. Yeah,

in So of of outside there impactful own what a line and is extremely done the with see the is data. most patients. say independent, we our data. I positive research own much very nevertheless would to is that, it what are with and as results research publications in physicians being that our growth the we their marketplace lot third own call data that's The actions that relates see all the party actually

in see the So, positive that actually the to utilizing start stimulants is it the actually the in physicians reducer of impact and once does the what and way a patients, their own long biggest market. biggest in growth over that the years we observe have where -- driver been that for actually time. we We that seen have direct a Germany, see the we

that France. seeing in clearly are We

at patient had COSIRA-II we you been their and Cleveland and to participated We does the in already are were we signed some positive the is patients study added I tell saw of compassionate going and in big in us up and US have in the the trial that compassionate reducer that's results in also they population which and who it, Detroit physicians and getting clearly UK. own seeing excited what study. extremely in can enrollment about the that support in in participate why the of use, in also the even -- in before the that, use COSIRA-II did clinic,

to population H. and believe Vernon success and I experience actually Operator Please is question device C. biggest growth markets -- ahead. are next all the So from Wainwright. growth own that, we drive the Our basically clinical continues for of world factor is go the Bernardino in drives of and real with reducer in. their experience real the the patient the the

Vernon Bernardino

hey, Thanks and for my congrats taking and the on Frederic record quarter. questions Chris. Hey,

an talked sounds lot you So occur far something about as like for where it Reducer. could a where bit sales the as is -- and U.K. really of a the it acceleration opportunity, direct

what you have that a characterize specific bit little you with to if now you there? force see sales could wondering better Just this expect

Fred Colen

Yes.

own had that market in obviously, a profit selling the obviously, So in And and has the margins But UK when to distributor, and their gross good its in so the really the than at price itself. a is mind distributor own a expenses. relationship. distributor we sell an it different we basically and margins excellent distributor device

the number a Number pay So also reimbursement the difference, we of with well recommendations there, enthusiasm there the that because is only in for NICE. additional have positions based U.K. two, that's already up the one. big clearly we that the see in but device the not from national as as on place expense

treat now able device. for the a an to was to patients psychologist is a recommendation recommendation they patients official these For endured. time there pain to to ever, the deal with with visit prior that these The first be

you that what's see shift big terms in So for a recommended what being of is can patients. these

were even with negotiations able to good and to So we start in very early. the amicable distributor, basically

distributor Our agreement year, actually running had But certain several the facility which in the people as second the for to pay we for with and start the we his have of we a done. the lost in was process. year, July, half the of end engaged market UK fee direct this the in out already to of profit of already negotiated for we the which at distributor have obviously the sales first

the to additional really we great really are for and are with a we in in forget additional business build process actually believe And speak we France, along person that for We big us in as basically strive France, of new Europe. markets opportunities really U.K. growth hiring UK. an the shouldn't us growth

Vernon. us, for positive So that is a very

the remarks, had the the that XX% was currency down was Now strong don't I'd Euro in Euro said I to headwinds. At mean, times U.S. dollar. compared in forget we against extremely of the weak say quarter. the my I backdrop

when a so in has quarter. talk that big achieved had a you impact. about And nevertheless currency, revenues European record We

currencies But really European future and the with us are a also more the we back see normal all European are in scenario. again particular that And we quarters. to but coming also opportunities in what help hopefully in the growth that, So UK. France of will in outside to markets, big used in

Vernon Bernardino

far sorry is in update missed France? as I'm efforts the the What if And I it. as

Fred Colen

Yes.

in We we working, we France. France, contribution that's have so already of well on have else, in revenue everything France numbers year these reps the France. place. as because and that from substantial France. from And are sales coming national from ground So on last in a terms in have in them, = revenue any and we of did had reimbursement We have not they full several hired top obviously we

we didn't, in fact of another that big we the as growth U.S. then last growth the the revenue again, generating driver. those you So the year well big devices in and in now that for the drivers are in the And additional and gross reimbursement randomized because add redirect COSIRA-II that trial, we as fact that's for us. the to used are France, UK, see

couple of just about grows, we you optimistic next penetration really are growths for revenue. that's to expand for outside the why So continued of see quarters. opportunities big And us big the quite

Vernon Bernardino

France forward to Terrific. record again the Yes. progress congrats looking quarter and taking and my the I'm questions. seeing on in

Operator

question-and-answer we session. Ladies the and reached of end have the gentlemen,

for turn Fred call Colen back like, closing to I'd Now remarks. a

Fred Colen

Irene. you, Thank

made great just the quarter breaking in some summarize and in the of me let with we continued our believe strides record across board just say second XXXX I and have revenues business. So, momentum that

long half days to joining toward come, all to And today for our grateful discussing are accomplishments call, very success. we much of in this the We very call. the are marching from that year. back I that, you and your goodbye. earnings confident forward and we to participation thank look With today's the term are for

Operator

That conference. us. conclude today's Thank for you joining

disconnect now your You may lines.

Neovasc (NVCN) 12 Aug 222022 Q2 Earnings call transcript