Neovasc (NVCN) 8 Nov 202020 Q3 Earnings call transcript

Good day, and welcome to the Neovasc, Inc.

Third Quarter 2020 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Mr. Mike Cavanaugh, Managing Director of Westwicke. sir. ahead, go Please

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

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

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

afternoon good and everyone. Mike you, Thank

of by Reducer QX, quarter We the more achieved pandemic. COVID-XX of Reducer implant XXX% are Despite XX% health delivered franchise. patients and encouraged who cornerstone even care are visiting DACH team experiencing the These the worldwide Neovasc by the the challenges the revenue we strong in which difficulty posed countries consist in Switzerland. growth, despite are XX% providers, the a of growth Germany, encouraging, growth important and Austria, revenue implant countries, Reducer their

margin, Given growth European and strong provides our leading acceptance direct the and in the of in Union. sales driving the among Germany Reducer countries the force

multiple million also core approximately up that our August, convertible July impact in $XX.X and refractory Medical has to financing Related perspective, August We QX down now before, are significant of We of We the Strul capped is optimistic exercised midst in to to transactions structure team, fund lockdown quarter. market. debt. work we warrants to key the of at significant opportunity operations renewed life virus at by performance registered large and outstanding small work this assets. the our because May retire product QX, reduced emerging hand through in value pay in shares indicative million have for shareholder, severe our truly want and even of accrued $XX.X would important not same which investors time, Reducer’s the Neovasc As reiterate cash and to patients QX debt have possible prepayment angina we current been the Group, was continued in that results. a disease not is off the the again debilitating every quality thank offering from was not of We to are once by netted investors XXXX. said From value the impact issued on with support. of less want severe I almost capital million penalties. strengthening principal, take we believe $X our company’s interest in a recognize the utilized adequate this of our and the priced a of a March the and XXXX, continued fees. I used strong if cleanup did with the European the pandemic. activities easy negative This market, and this potential. with proceeds COVID-XX throughout otherwise market on The to a their direct money believe by have after tolerate of to flare to

PMA, place third panel it of like the and is I voted for Reducer reasonable XXXX. Premarket Circulatory in assurance Application, would October the effectiveness. The now Although December favor known against the FDA’s used of the a when quarter to Devices X:XX Meeting, XX:X Systems results issue of as Panel which close, which voted Approval the XX we safe after address a occurred the took on that as in Reducer submitted of in late regarding intended,

the relative abstained X was The on third the vote outweighed X:XX whether relative risk. benefit against,

in very panel, granted granted some the have review One, a disclosed. meeting; sham-controlled considerable Neovasc was The history, in of in England data clinical the met its results outcome in previously difficult submitted I COSIRA actually obviously the of from [indiscernible] a set Reducer a that While published the sham-controlled, consists an of end primary we as studies for data to pre-market and patients. Journal advisory three, patient to interventional cardiology the first XXX designation; device for of FDA New population like were we study. our Medicine. double-blind, randomized two, primary without the point would panel the request are breakthrough of study study disappointed The endpoint FDA one

our to X effect clinical also with XXX we COSIRA observational data study with the years. We enrolled in Reducer from confirms up seen over submitted patients current that follow-up, believe X

in-human follow-up also on first We provided data [indiscernible].

filed real-world considerable study. further committed submitted experience initiative to that in Additionally, the post-market conduct we Four, confirmed studies the sham-controlled we COSIRA. robust investigator seen results a from published company

considered all XXXX, we from reasonable statutory of I effectiveness need panel, particularly with we believe the path were totality to the relevant of considering details supported the assurance PMA, panel to of options and the quote, safety devices meeting, subject that be that context FDA the breakthrough population. we December refractory as breakthrough of of also specific treatment the subject the guidance still standard devices into FDA the the Going of anticipated PMA: angina seriously There must documents approval. number patient for of program, with time documents PMA took and the a) data at devices guidance submitting would by limited a the

to efficient determinations the device consideration in uncertainty, of In and the classification device exemption. greater novo intends August treat breakthrough a benefit three approvals, scientifically facilitate For this greater devices, device; the treatment-resistant appropriate reliance post-market PMA, and Xa device risk collection. and FDA discusses and data b) review intended de uncertainty, the condition. uncertainty example, major to development designated of they XXXX, level timely medical Example a collection use expedited breakthrough on a from as pre-market data of post-market discuss humanitarian of to guidance when that from scenarios the

benefits want the patients as access We and specifically, timely pre-market novel meeting. the December appropriate, innovative right and technology greater patient program from data clearly can position assurance in perspective, that collection of all August point options you finally, that working for to data consideration; I factors quote, classification, devices panel’s on needs; choose are pre-market unmet extent Again, benefit data risk here. unmet study safe in pre-market to data about data devices, of our collection approval the real-world supportive collection, advisory Reducer, subject XXXX, addressing As with effectiveness, we medical the support risk consider I approval, robust a devices recommendation. PMA and more risk no believe reliance de post-market April an when presented to access collection, in must collection, the in where the the vote. in submit reduce novo available And option especially I forward availability and to d), and panel of need, would between are for pre-market to But from approval stated hopeful pre-market company did Taking patient with alternative, a post-market panel’s a the reasonable FDA’s the outweigh a request medical this of given Reducer XXXX a of c) of of we earlier, we including patients will and determinations and uncertainty, provide on getting XXXX are the to that submit assure the of balancing and focus guidance post-market medical the await time, volume post-market this had, for for making into consideration all decision directly clinical more the the balance high documents medical this given effective we PMA. on we to at move and safe we to devices. data quality, from have population. impact We when mitigation,

device, traditional and patients. This with life-changing patients it you announced far not important been lives. third update Reducer it able in those data. XXX results soon Europe is a on of And with their for penetration avenue as continued active in to the also that cardiovascular more themselves they acceptance many, those quarter, The will of possible. is Reducer. healthcare consistent see that professionals the treatments. from results And any and the published the market. new in treated that lead It are treating resulted of are into in acceptance with the our in elsewhere, We suffering treatment pleased improvements. the an Germany are have has using is patients the Germany to we for Late implanted seen and to and importantly, developments disease gratifying painful German unique a further milestone the with majority the increasing it noteworthy that so Moreover, is demonstrates have responding in as provides Reducer

Mitral Reducer continue program. and to Tiara great center front on our make has been the we progress replacement While Valve recently, also

Tiara Neovasc valve our medical ongoing. mitral the are CE device system, TA targeting TA under We The is approval transapical replacement a submission the the advancing Tiara European review regulatory directive. submission for Mark of

as have We still review, answered from a filed while many in expect progress the TA additional questions we many more notified The to more the to answers the much body across potential encouraged the with half XXXX. to and targeting reviewers questions Tiara body, reviewers by many at from approval are decision first and is notified are of be and results for information European company we date, not submitted.

D-shaped travel COVID-XX could projections We COVID-XX sets enrollment hold. our profile, low challenges. first the Tiara stated successful, valve encouraged it received in to timing original of replacement transfemoral Most company and transseptal have on which, medical of already temporarily The on offerings result competitive is notably, implants the from the approaching the of our delayed during in system’s if in half committee. is by XXXX. device it implant physicians executive recapturability is to TF, implants due program, supportive primarily device This are from has The feedback important the in unique Tiara-II design, the positive animal first-in-human from apart that and mitral is the development. past lead QX, restrictions,

believe In the Overall, meeting. quarter, our We with are and system. continue to of although we TF panel in size broadly be reached than on Tiara potential more own to revenue achieved market systems growth recent pleased outcome patient the we in the XXX third expand under transapical applicable development of and and the the strong Tiara quarter, in the the Germany. implant Reducer milestone third disappointed FDA the competitive

notified decision We advance for first and half Tiara TA Tiara XXXX. the on TA a Tiara devices in application body the and targeting the CE continue our European TF of Mark are by to

operations to and of We in first through capital also will funded XXXX. progress made solidifying the I structure our Neovasc now Chris the discuss financial turn are call now to results. quarter over

Thank you, Fred.

COVID-XX third the quarter recovery impact pleased with the in the in of top of We are XXXX, the second following line quarter.

as for of basic expenses the to or quarter $X.X an were representing increase and for However, for by the period. for within a in with XXXX, third year financing expenditures prior to quarters. $X XXXX of period we $XX.X the diluted we or driven impact XXXX cost on and million substantially supply our Reducer million the quarter in share The development capital development operations our severely issued in to General XXXX, share at a third the the focus third was overall in $X.X believe margins point legal The period was could increase cash be million, Total by we and of million to third increase consistent pre-COVID-XX comprehensive compared could employee-related ago, mid-XX% XXXX. continues incurred in the costs X But staff. share-based the increase Reducer per and quarter loss Tiara, for of $X.X restrictions million and $XX.X to of the period principally our improved $XXX,XXX, XX% loss Revenues to cost for the in in incentives million, same and were $XXX,XXX target million a products, expense $X.X loss an $X.X were Europe levels increase the sold quarter and our an was clinical operating $X.X regulatory headcount and pursued XX% goods Credit orders quarter loss each Neovasc and cash compared diluted approaching XX, an post quarter this same compared for increase for the for expenses quarter annual principally generated $XXX,XXX million of The as the for in to cash and for compared critical million, respectively, million XXXX as compared respectively, or $X.X basic in $X.XX execution million expenses development the $X.XX driven for the and optimization with chain. fourth per for performance. quarter of the properties non-cash the million. we coming debt had March of $XX.X to trial range. $X.X inflection million expenses XX% the the until were company approximately believe as of margin activities, same to returned sustain $XX same a period compared burn from revenues finances with $XXX,XXX year-over-year expenses to compared XXXX million add and increase company in administrative financings. September XX% increase operations $XXX,XXX gross it $X.X same equivalents by have XXXX, resources The the sufficient on start $XXX,XXX and The the in operations, at fourth rate. of to current expects XXXX. cash to will equity in of XXXX. that at period. hand in a

nature give shares, to market of meeting, retain the the During impact Neovasc due assurance the or to all. we’ll the the panel of no be needed company on agreeable FDA funds the that of additional terms at the company the outcome to can able current

shares. As and XX.X today’s shares full issued share has million with of date, million count of XX.X of outstanding, the company common

and company. as the our the look options path XXXX, determine operational all the this reviewing the we Fred? for fully to are rest into best forward We and of updating we year strategic for forward and market

I opening now for of thank trust it for again Anita? all up investors our want you once to their questions. thank all We to for continued would and Chris, you like open and our thank remarks. listening you, support. and to Thank

[Operator we’ll Instructions] you, take from Thank Leerink. question Wang sir. our And first Rebecca SVB from

Can you guys. me? hear Hi,

Yes. can you. Rebecca, hear I you. Yes. Thank

Is options Rebecca. made trial I’m you Thank a just is the bit my do Can require SVB on more This to Hi. how for I control you panel? potential don’t your to question. the should those and in color Reducer? Leerink. will by a know from leverage address give randomized going calling we a And can little of concerns that very to pipeline those call you money you XXXX, think we much. you – Thank options March strategies should that with advance capital and take the but forward? to had I appreciate how spending until enough products? how you about some Europe, taking

Yes. Hi, that for Rebecca, so thanks question.

So potential on thing or the needs decision as options in you totality. to at That we then await what FDA PMA. might is as that available I call, first have the will have be decision. are can to company after clinical FDA’s said we await see now that that, I able happen. all to to the its do to options in assure FDA’s And And discussions we we first on the all as well further we available with not. looking regulatory the

would to And Reducer that, has itself, an thing other know, always and like in assets, is we so the pipeline. in The point X other as one that Tiara. you company that, the that and the the have advantage, gives us out I

We are in a continuing with Reducer to see the Europe. progress great

with driven, which patient the underlying strength of of experience to was physicians’ the the we growth saw is believe, see Unfortunately, part, where As most little we the lift virus we a we bit But are reduced third the be from the for population. reported, going up impacted now there product more their by certainly with device own demand QX, is big in the pandemic. quarter, really in a again. for Europe, own

transfemoral transapical the as top script. Tiara that. continued alluded my to well both have activities as development that, So I as we have we of the for for program, in side, On the on

forward will we company. the all additional March, a look also We confidently future. to at financing look into opportunities and certainly options we and move we at will now between continue how as look and So

setback Although forward move are have options and will and there’s we and to to still obviously from move this forward for will available here a we was good and company. all has us we opportunities for believe working to us been and the

Great. Thank so you. you Thank much.

take Thank go from from you. NOBLE Please And Demir Capital next ahead. now our question Ahu Markets. we’ll

political line question. does regarding what much case, very a that panel. like but curious any FDA taking later Were you’ll any there timeline give the trials? points you any Reducer’s for the the the spot the just of for points ask my look to your you actually question the on, change I mentioned other extend market, know strategies detailed of And trial actually aspect Thank would trial? the time was to like? I information or I that prolong clinical clinical

Yes.

that these gave was the positive, for by mark supports As before fact panel I the that it the turn I actually as meeting. say that we side. it voted This we clinical data Unfortunately, the obviously the of outcome indeed members, risk. do panel position the as said a would the presented of in I that presented. all we as to that to And are data clinical believe that the because to of for mostly and Reducer the have Reducer. we out disappointed We the totality had effectiveness. the data relates reviewed. it over documentation opportunity want script, we for – that to efficacy Reducer to not in safety – be and detail on and present related an is with did went the very That, safe to benefit panel we that of out this be voted is a believe my the carefully the actually has and through very still combined data why panel reasonable have chance safety clearly guidance, therefore, guidelines specific point we I that more positive

speculate it the not we is first But that. it to would and the FDA’s to beyond However, now I we is, needs have outcome accepting on and await anything and are like of that what meeting. panel to decision, come

do FDA what what see we on for the will thereon from we will pathway regulatory clinical and We says, then the see Reducer.

available already move working to also, though, are the options the forward. to company on a to available in As continue meantime, all we us we have

you, Thank when clinical hear you Fred. you about studies? STI you on this, can the and details the follow-up market might might And from disclose

meeting mean, and wait I just have timelines, or takes months. on But so history, to panel and comes. the to what a FDA we’ll to the the few typically, That’s X based So months that see to happens we’ll finalize after in observations process. see so X on their another when next general

question I think probably I the can answer how that’s best now.

Thanks. on but up strategies or you in process some I will to, my strategies any plant you of implement was close-on know again, be the expect course, any to France. Do last corona, we Okay. to due Germany, team a to Tiara. the delays curious, major And by places plan other move do question not? that in maybe second to like additional little speed bit I

Tiara about You are talking now?

Yes. Correct.

Yes.

we going the on in process process. detailed Tiara are device of through and transapical So the terms very Tiara, for digital a very lengthy marketing

So working notified the we with are body.

CE filed Mark we are contact or a application, And notified and We the have approval body. the constant continuous with in the transapical European Tiara device. for original

have a lot questions. We received of

of have a huge answered questions. We amount

data, We additional and a have so. lot submitted we continue do to of

a done. human the able XXXX QX, of the set half first Tiara sometime and device relates as first the given the CE European we to transapical be more be in there’s And those Mark still sometime we stated some we well, transfemoral the There to be then are quite implants decision would be And to body as approval yet. notified by well. potential go on in half expect anticipate ourselves Tiara more expect, up for animal through questions before, submitted. not that during If XXXX. and we are critical a We needs have of still to answers the first to for it we process a entire program, as implants data

that Noted on us at months actually at So looking I ahead through next another our financing year. first certainly also those the option are of are the program. any financing have encouraging. And key beyond are is least the we And that. we of extend quarter quite think the to for potential run Tiara those milestones that three

very you much, Fred. thank Okay

Thank you.

you. we question the will from Bernardino H.C. Thank And now Vernon Wainwright. take from next

you and much Europe regarding to promising Hi data trial everyone. and used size the of be another is in the use be revenue Reducer, do United think Do how needed would to should a to Europe, So conduct from in should you States, that in right? clinical have one? adequate

before have trial we believe be in the earlier. would we that such of stated Well, range stated that about $XX We million.

think However, wait the about different meantime, at on in a and and I and time. it’s we as in make to have company. need all too just to are decision more continuing point that that options progress this talk early We FDA’s the we to PMA, then

probabilities forward. the the a And ways, also what that looking in as all is best a are at company, as path overall. We many regulatory-wise moving different company and is potential clinical certainly

there. once have we’ll In wait all Reducer, FDA’s options decision that and get that’s we’re update certainly then we’ll it And have at. the on we might all from the and meantime, we more working that on, we’ll once point for we being on different updates and take the looked So everyone. that to

sense. makes That Great.

up taken hospitals there. Europe? useful being really patient. out you lower and It’s procedures has As go in your have companies as they of and environment. are just just swamped in activity? lot that again as have Do continue are COVID-XX crazy through and been seeing by would other elective few Or treating done in far treating procedures spaces What cases a this how to

Yes. Yes. Right.

the DACH, the busy So very and issues, hospital I had should – I in patients. providers we, quarter, but had side. I biggest contributor in pandemic Germany, only, growth QX big the implants strong Austria COVID implantation a bigger call as we actually quarter-over-quarter the and who not should And really a growth is say even on still, which headwind with and Switzerland, in in particularly, where before, side the of although And nevertheless, it, said that. no, Germany XXX% physicians had growth first some with terms are of let’s revenue in lower-level Germany, say, quarter, that’s on was COVID we

is And of quite is going very we the is our why again, said very I’m you encouraging. many impact December, COVID of QX, So COVID lockdowns all underlying growth beginning see seeing the markets patients. the into in we major a Europe again an have because and few busy are in the countries, But business heard demand that that hospitals to flare-ups at therapy European the which and a also least the virus, sure there. in and are, with through that we of

the already of we procedure So in quarter get seen have as a want list as second where the the and to have Reducer before postponed, we patients well. that been has

the in we pandemic say countries. to the QX. our wouldn’t back have is that but really it for be came we be believe we would case in many European QX not So clearly the even that pandemic see plan, Europe, can strongly We an impact in been We see going strong on if indeed because demand. rather

an is there a impact moment. bit the quite at So of

still we for and see to continue the therapy. demand growth have we and underlying seen strong So

Okay.

we are really to some guess, has return at hospital to growth already just because at in excess improvement they all could momentum I to as great and see looks perhaps in XXXX, that So It’s these is is point. the and point able just do can, much like the recognized. because some in lead which the as it lives benefit fact,

not leads very did of did terms not safety, benefits benefit data over the was believe just the lead that think the in perhaps Reducer me. conclude on AdCom so at of But and and benefit then is that safety or broad enough if to about me to and [indiscernible] growth. over is there to same safety the Regarding also the a intriguing they what time, abstentions, safety amount in they enough enough or that the conclusion with

first Reducer of to in vote of pretty would very of clearly all, panel did, clear, I so the price. favor the Well, safety be say,

of be did the factors that submitted. as from should totality in are strong One really XXX And studies factor We I And been to unfortunately, device. all the I demonstrated went And that very efficacy the we investigator other the I through importance trial. think X is the script. I as with that the X there study. went collection. published, think was devices nature data was are for in little think our of breakthrough that guidelines first Reducer We risk, opportunity thing look and which was the data the very patients major independent detail panel, to that discussion FDA post-market from the clarified. of benefit not different I many that at the and over that about that, consistent post-market is on in it breakthrough relates the a submitted that efficacy submitted the for the my have why COSIRA very is there

aspects the panel was that emphasis the study, And was really to as the so submission. possibility FDA guidelines this post-market forefront the I of wasn’t the another and robust meeting. put around as the I part thing on do this propose in think And different put more we at a to of that I did PMA discussion said, post-market the study of think,

and factors, script. I my key those in alluded to So are the much think pretty I that

there Okay. what presented. It a get outlook the lot good guidance. Obviously there’s as was to far through quite a as they and bit

could would don’t a that could go? the very me, saying just Reducer? FDA’s ignore and you that’s the small no still to expect, get chance there’s you they and chance agree why definitely only it to for chance ignore a they – you waiting or efficacy or is you there looks for just for you to and really that because decision that’s approval say so are could still you And that Are that decision

What I already panel given less on now stated much this of I that we stated are approval. an outcome that the before meeting, FDA we where before. already are positive that and

just really to meeting. FDA panel going But really wait what are for to originally on have basically saying to are we given But panel what the the don’t We want not will are We say. we again, see report I and is meeting, – we counting FDA approval. speculate. at happened

and I questions. Thank you my clarification. taking Okay. additional appreciate the for detail

Thank you much, so Vernon.

call. this In time, today’s you. this today’s the Q&A interest session, you for and your of Thank concludes conclude Thank will participation.

now may You disconnect.