CVRX - Earnings call transcript Q2 2022

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

Operator

Good day and thank you for standing by. Welcome to the CVRx Second Quarter 2022 Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker, Mike Vallie.

You may begin.

Mike Vallie

afternoon. Good joining CVRx’s for earnings quarter today call. conference us you second for XXXX Thank

today’s the are which Financial time. call, Chief on financial of contain me Joining are today statements including plans Nadim The today about and and forward-looking Oasheim. as statements Executive The company’s over Yared; its on Jared may Chief statements change Officer, guidance. remarks will based Officer, and President expectations

and uncertainties Chief addition, this a I risks will call In SEC. Company's would the results the number earnings the the that materially President could call including filed Form Officer, upcoming the the to over CVRx's those to due including now Executive release Yared. actual differ in SEC prior Nadim like in filings, with turn and be XX-K identified of issued and to

Nadim Yared

results everyone you, of I our overview joining thoughts will second questions review for by us thanks today. quarter the answers. XXXX an of Starting operational conclude and turning second a and before of And performance, an Thank begin providing then Oasheim, the of rest call our financial with for by quarter. update, Mike. by with the CFO, Jared to today’s I’ll our followed our to review

seen States XX% to and expansion This an positive increase revenue of average impact Our of increase our by centers units to of execution existing expansion into campaigns. volume. increase we growth number our commercial of quarter an new revenue internationally. results total second record was million, in and business sold over a have an awareness was supported the centers, the by XXXX, of the $X.X in the Throughout in quarter from generated In Heart quarterly the strategy, continuing increase continued Failure growth United of second were the the over their XX% and implanting million, marketing implanting quarter. the due resulting approximately U.S., XXXX, of $X.X both driven XXXX. our These strategy,

see commercial second support quarter continued trends XXXX. adoption the to in you development we operational from during to encouraging the and the fourth use want I Europe give now on some quarter Additionally, an stemming of of Barostim. have update made greater to investments during

As a One, reminder, of the expansion and three, our are: expansion portfolio; Two, our commercial innovation continued focus the evidence. infrastructure; of areas clinical product of body the of

infrastructure, sales Let’s begin with commercial the direct organization. expansion continued specifically U.S. our of our

expect three Barostim add the The the about territories, new to we territories bringing three the expectations. and drive continues the organization XX, During exceed per to adoption of added of an quarter to average their sales of and our the XX quarter, new total finishing caliber ability territories. we to with year

our pilot education geographies, headway We select are direct-to-consumer is to branding making patient conducted positive support where with being our new in program campaign.

to to ways for expand program We optimize the will continue look we as further.

with device. our to aimed Barostim continued institutions patients patient select in about who education we Additionally, our are speaking already advance pilot physicians at

the program expanding to-date. made The the additional expanded our marketing and started with has direct-to-consumer to are gaining we we program program of progress first education pilot With successful, this and institutions. traction, been phase happy have both patient

rollout, these to support optimization the programs. expertise successful in in-house XXXX, continued continue of invest including of For will remainder to the of we the expansion, hiring the and growth

Barostim first of year, In related is product our of Our approval three on the half our received we platform. portfolio. of second to pre-market the innovation area focus supplements the clearance

under undergo Conditional MRI receive an allows Barostim for conditions. all who patients, Heart was MRI device Labeling, first which certain exam Barostim a have will received Failure to The or

our new average. programming generator, our XX% on longer factor And prior than was software. is size which simpler tablet and generation for was The second battery programmer, implantable for is a in even life which pulse with has new the form smaller an third

We in launching new the process platform. the of are now

occur is the in events, population first expected the with process, Heart clinical evidence. on BeAT-HF Fraction. more benefit and our track and the of we clinical with provide by final all of Our the expansion body time for mortality XXXX. third patient half un-blinding of collected review the believe to trial this focus the have necessary a which the continue morbidity events Reduced end to all detailed Failure remains designed of is accrue Barostim of year. line The of Once Ejection The to during demonstrate will will the BeAT-HF required we we

track In remain Guided our Implant Ultrasound BATwire, with on we addition, Toolkit.

half first we is second the quarter are performance for we what with it happy accomplish. XXXX, trial able the We continue some by XXXX validates chain fully inflation XXXX.Despite to in COVID, the of demand growing the in difficult immensely from in challenges end seen expect be Barostim. to were The approval of supply as to enrolled the and and expect FDA disruption encouraging

Looking commercial growth we ahead, plan financials. continued over XXXX. now Jared. the are the of on turn for to track to committed our and I’ll call to Jared remain balance our executing for review

Jared Oasheim

and $XX.X in driven was XX% to compared the primarily in X% second of which increase XX same which and last last Gross expense eight Gross second continued an in compared at period the was when XX% to centers at an in SG&A XXXX. same for U.S. due Research of to margin the and of same in Gross of driven of for the year. Revenue for $X.X revenue quarter by totaled in second period compared company shares cash quarter, the million in increase QX, is increased weighted year. quarter same for by the to U.S. percentage compared our at million the territories, increase quarter the an generated unit a driven XX second physician million total of selling Thanks, the for Barostim XXXX. of currency cash cash period increases price. $XX.XX an increased second coming commercialization generated Total in in a to million million impact XX% or for of was investments for in is per was increase $X.X when quarter, million second million in on compared $X.XX Net end compared year. expansion loss was an decrease year. end second period was versus last systems compensation the Failure in offset quarter, XX total European loss cost a activities offset were US. At organization, the U.S. of second for year the accounts for due to replacements. the to XXXX revenue on second an and XX margin same battery we last last the compensation, Net and expenses approximately related based year. quarter, primarily average the the and profit territories period XX.X by the units. the shares higher same year. at million from to associated development revenue stock implanting end primarily our from result increase quarter when the XX% outstanding QX, quarter, of to quarter, into revenue. XX% sales QX, had of and end the $X.X awareness travel second in the second used The revenue per year. $X the average partially of At COVID-XX operating in increase $X.X generated the increased total period QX, average to million, headcount, compared the we $X.X of headcount. the investments same to and in equivalents second million, revenue when revenue new as is last which $X.X revenue due XX, as last $XXX.X was with was million the second last end in had increased and pandemic patient compared or XX%, to and end million quarter compared This increase Nadim. $X.X XXX net the investing is last expenses The weighted year. the of increase million change of and over when the to the a in growth units QX, for was compared period partially advertising quarter, a to for Heart on were an costs, X% expenses XXXX. quarter, of the of an XX XXXX of Germany to public the compared by of Europe of increase This larger last active full impact quarter which share units period same and an was XXX% $X.X sales new Barostim. end in $XX.X was to the This in period the same of approximately XXXX as of marketing $X.X the Europe in year. increased the which million the period or by the as primarily unfavorable Total XXX,XXX million. units is same XXXX. $XX.X the second $XX.X the on a a continued Revenue the the share quarter share second per the per lessening the outstanding Net loss QX, in commercial was were At to increase million of was

we to cash our initiatives toward continue in support growth as prudently of usage monitor profitability. We our progress

turning Now to guidance.

operating $XX and and the XXXX, between gross and XX% million. between we expect revenue $XX million $XX.X total For margin XX% million, $XX.X expenses now and of year between full million

to expect total $X.X third would I the to the call between revenue like quarter million. million turn over we $X.X now to of report back and For Nadim. XXXX,

Nadim Yared

Thanks, Jared.

momentum XXXX. developed first positioned that momentum throughout the to accelerate and throughout rest adoption second the well about the leverage And are we the of of of in have XXXX. the we and very quarter Barostim enthusiastic are We half

for for Before done have us at everyone the get I tremendous to today. are open to work they the I we where line wanted thank CVRx questions,

work hard it and the of have point of our to only made dedication We team. because this

Now, line like to open the for questions. Operator. I would

Operator

Thank you. [Operator Instructions].

line from Our with comes Morgan. Marcus Robbie first J.P. question of the

Your line is open.

Unidentified Analyst

for on quarter. great on the Alan is, Congrats This Robbie.

to Just the macro-environment U.S. on in the touch

highlighted be that first had the your for volume had you continued to On staffing quarter, shortages challenge growth. a

trends and like I the what develop to does have the back impact So, guidance the the those assume your into year? continue in how for second of guess, quarter, half

Nadim Yared

difficult; was Yes, of we had joining tale recall cities. first if so United for the beginning us. the you two you the had in of impact thank States. quarter remnants The COVID some Alan, the of quarter

was possible, the labor of negative of labor patients impact and for and it’s shortages us And second seeing. burden shift The obstacles the we the wanting we are half clients, we’re the why of type our to that translated our we this education. the time one of are and with of program ethical able results some [inaudible] the of do, at commented and quarter reducing that shortages to has were being shortage solid. to And do and willing, the that’s seeing trying legal into we the staffing at overcome education wherever actually about to the very

to guidance you. next maybe relates turn I’ll it for to As quarter, the and Jared,

Jared Oasheim

Yeah, hi Alan, is this Jared.

guidance the are rest bit and the new center for activation. hospital a from to still related year, for staffing as for a that So, to we headwind see of expecting shortage QX of the

seven, nine to added digits we we quarter, second of meaning quarter, though each in or for the added QX to were in able the even in expecting the so numbers are or seven, in be high nine QX, see single new be eight, XX centers And the year. still rest for net this eight

Unidentified Analyst

benefit benefit earlier conditional from then, half? And those got programmer in guys. new how back it. kind the you approvals year, product about approvals, think approval the as MRI what know should on well, the new we you seen new of have Got the and Thanks you the from the

Nadim Yared

thank Good Yeah, you. question.

MRI, to you a communication to previous If did on programs not but customer expect expected minimum. that better satisfaction patient MRI the rather Particularly patients with without be new not. know product recall when technology. to additional We they the our conditional and revenue, of had topic, you this generate we impact source it, from be these an compatibility, undergo could and our of a better

prescribe the certain right to it So, this MRI they ability an labeling, in we this. conditions can that of limited order are patient. for is an if With new do example very stroke now, product, physicians a to MRI excited have we’re patient under our labeling a or that not about the to has, and related our diagnose

and about form the as the it’s the increasing road our same and about factor but with patient can of satisfaction, the size the So the about technology, the and product device, and said nurse of form be more factor battery smaller also about ease physician new portable and programmer the longevity down the of use well. satisfaction

So in notch of summary forward generate we to move just us but don’t those satisfaction. revenues, here, more a terms here expect in rather

Operator

Thank next our question. stand for you. by Please

Our Piper next with question the line comes Sandal. of from Matthew O’Brien

open. is line Your

Matthew O’Brien

question. for Thanks my Afternoon! taking

a far this in can over and that’s last your to Jared talk you that there to couldn’t best bit, this bit maybe get And centers think so add the new then why that then because Were of later going feedback if company more they then was and like helpful, there I centers about as think year? of I little so do opportunities you volume add, a that you access in were kind have those you? be follow-up. maybe started some QX one I but are center that little a staffing better, couple know some for did quarter facilities, moderation delayed the Any should quarter of years. would issues we you of higher was expect and the address had public / you’ve this

Jared Oasheim

Hi questions. Matt! Good Yes,

center in very was trying I we’re to a to really hard second new yes, and earlier, It’s did obviously see that through. to we the centers see come spike we allude the with in quarter So happy numbers say did back with that as some you happy be patient holding implanting what metrics, but officially know in were an treating centers the active to our these first identified was we of saw. we from results that

our on an the targeting after basis. focus going were the that centers centers, added, high being as As treating patients new are and that far volume ICD remains on those annual most

centers board However, when work more to obviously that to we Barostim we some allow treating physicians are those their patients program, therapy them get regional well. an to of with with from want start a inbound get going on they and request to this start as them

and that out and that we’re mix and those those out a high more us the So of device. it’s asking reaching still volume utilizing of is centers centers are to targeting, going some start regional to

Matthew O’Brien

Got centers you that more it! doubled And last than this believe into the XX then came of about selling more units number people XXX many last How the quarter, talk metrics, before, you’ve ones assuming you into those – the a you the of ago in months? account year were over from sold. i.e., the year. here that have or the a active and got these Can number it’s kind matured last but the I I’m – of of some active

Jared Oasheim

ones month. of long-term that this After seeing every continues goal the then that their about are going set, comfortable more of to a year It’s testing have XX trying they appears months patient they saw one And often. seeing early they are quarter again dozens we’re right. year are are here But they the up be that how they in XX mark, still second one that, monitoring more. step reach are accounts one and one to starting reached treating the treating inflection have data that per that year, trend the back patients it to timelines get the where per they another volume, of in we’ve XX-month reach mark, almost is when bit that the the and starting come center, that seeing. centers month centers, under mark, and don’t been they more reach dozens one that’s and yet. the device, month point of we’re that trend treat start month little so to Yes, that feeling around then what months it once per newer we reimbursement other patient they of so is trend be where every treated to on the third they starting mark, or XX-month is but that a doing patients we’re are works patients, still We cross start that small seeing once are

Matthew O’Brien

you. Thank Excellent!

Operator

for by stand question. Please you. Thank our next

Margaret line Kaczor Blair. comes from the question William next of with Our

line Your open. is

Margaret Kaczor

that up activities Good Hey! I the strategic launched some just new wanted with, guys on and start account guys. of impact little to have follow larger the bit taking afternoon their commercial out and you Thanks accounts. for maybe questions. on national managers to the a

one, going just when in more you know seen them and series So have about you point? see over to and at we’ll us you’ll new this of then a accounts? update two, should the And we impact this, centered hear or updates time an it is be

Nadim Yared

that Margaret! voice. to the Glad Director, the institutions, single us that to multiple over the have the Denton, geographies, have paying IDNs contracting to but addition for Kevin hello hear goal in one us. multiple single and is territories, started that person process, ensure contract, following that others, Account your those has or a we Yeah, regards on yet Listen, Strategic of multi-site span

contract centers reason. what report exact do Now, under that an that we active not are are for the

sites that XXX experience, we we know one really, with least they this develop XXX up an this his report every We program have a because they at the program. report active Kevin but site practically agreement could in group a with at no, And agreement single therefore and large an active done at the to has the sign that that around sites, need implant month. the team You if so in sites, us. has team, have XX previous if implanting champion clinical and the site with don’t we sell

bottom line, is this So a activity. well-needed

clinical other and contracting You’ve the At level, a see part at at the high seen are imported, requires play a these companies to program. umbrella this contracting of work But it’s when levels the in similar where at lot with with impact to of it at those high lot of the level. it our prospect. starting also we’re simplifies still a a that’s the signed least stage, team and develop

Margaret Kaczor

great! according colleagues new if of you high accounts. the it’s other up, larger just was to Jared, new like to a the it the that Obviously, pretty And year end. to number. increase two had kind going follow center just rest what like does we centers year, on new Okay, target my similar maybe to sound single-digit into then great see before of saw through in It

me reach faster correct that but wrong ultimately if prior these a So do to do expectations, seems it be ramp productivity I’m the about a our to little thing. that like good and extent that, bit relative should

So it guys. next as be useful, around Thanks to especially any you the relates would months? know XX that XX details over

Jared Oasheim

only that is, and investments. to open goal centers to at the a pace help drive help is coming implants The the and be the to associated patients monthly resources many as a contracts, up, going go that don’t pace I’ll make at the we or support patients a staff be to like point, some we’ll early and continue going here to utilization faster to or quickly to with of is it add to able onboard possible. these be to on grow going able we fast need basis thing the line could starting same Margaret, on. are sites new Yes to places said those and to before, If treat opportunistic. as we’re be as national patients helping we But put aren’t top at in to want be out

Margaret Kaczor

Fair enough. Thanks guys.

Operator

Please stand next question. our [Operator you. Instructions] Thank by for

Craig-Hallum. line next from of Nowak Our Alex comes with question the

is open. line Your

Alex Nowak

hoping everyone. to Matt’s upon expand question. afternoon was just I Good Great!

at looking those Barostim, with up or Looking of you’ll remainder path seriously and is frame just at out where site many the those year? today? trend sales be train or speaking can numbers, Just how currently say you the of of account the numbers maybe could down sites of let’s or pipeline are sites could there, that accounts throughout how many where implanting the organization

Nadim Yared

complexity because Great hey! to number. see here. groups. Yes large those not accounts could a it’s disclosed Alex, IDN misguide disclosing number of and we have you Listen, that Again, of the the this

we have? for count So example, or standard they if sign their we centers clinics? the in How an speaking, agreement say of all about hypothetically do let’s the How with hospitals is about venture The... help don’t know they OBLs how complicated, I this else that’s know disclosing it that so why into can with one. the I You that own? you numbers. we don’t tenants,

Jared Oasheim

too And here just maybe I’ll chime in Alex.

for always is, least this One standard right. a signed, of our we’re quarter responses for contracts at ahead

from the coalitions see of to treating start so start identifying those perspective, are through we are so patients patients. what’s coming implanting that that contracts And signed, an worked actually can pipeline being they that

as And between to as that how a from move signed contract so it’s far we they been patient. centers first visibility treating but have quickly some this, into varying

And there’s you data signed, as active point had too contract – but timeline know more we related that all the folks becoming wish those variability this an from just much we contracts so implanting to signed to give we at you could to of the to center. to informative

Alex Nowak

stable of or implants the a trended generally sense. would a back beginning QX to understood, on big that And QX we so there looking the was bifurcation the number say would the cadence for you procedure Barostim call, discussion end makes quarter quarter quarter say going but you site, had kind throughout the here, versus that Yeah, things of of at versus for volumes? per of

Jared Oasheim

that QX. able know see and hit in thanks it and earlier, did that silence you QX, that to mentioned numbers – to We starting March big we month a of recovery really then was almost be Alex. some in for Nadim February to January the procedures the Yes, up, bringing in for

stable QX, really a has it moved into moved into setting. we As

just impact steady hospital staffing haven’t COVID through actually so to seeing QX. way we marched seen all really shortages month-over-month, procedures, or as an perform the growth We from

Alex Nowak

the And seeing permanent? maybe understood. the on through you’re lastly, And potential the process, the reimbursement field? then update category CPT CPT pass one upgraded any that from acute to just make is an reimbursement. Okay, to Speak to on a just feedback then an just code, payment

Nadim Yared

address Absolutely! this, I Alex. can

will you from be are So earliest a to one the one you, to we’ll in years of be the process today, X will regard late docket, next the the society of they category process, course but takes and on CPT so and the step XXXX. three do the from it takes ownership about a and from we usually we talk it code, all – starts and not before know this moment don’t as XXXX. what with discussions you process. code my But physician in expect coding, to multiple not I XXXX, as yet the go it and perspective, expect them if market category the champion process physician public, started societies, the it. this we’ll disclosed and they have to means shocking The here we from disclose And is of soon one if get even selected so it early on will might to to

paid perception Yes. today? paid it that hurting three physicians this category course, getting is of In Are would therapy the us general, I experimental, a that’s Now right yes hospitals what gives getting because the yes. means. today? is But are now? the say,

negotiate course get we the to in they support a after procedures, forth, very and deserve of those need payment the have there we and the able field by the doing if are endeavors team so walking to procedure with they to and to is the and when billing and the headquarter payers reimbursement also billing payments, solid them this. in are the We similar processes, here get

from the average our the the code. $XX,XXX to as is the a And of the almost around of price that’s pass system. the existing Currently and situation category code, through, device, national pass payment $XX,XXX year which know removes you through this of which substitute we it, device have next In also pays as one hospital transitional the So $XX,XXX. transitional so this the instead $XX,XXX, regards that year. price with is

economically So that decent giving a is hospitals to patients. that to seems is viable adopting continue be for for reimbursement. That Medicare hospitals Barostim

known a patients, than the the does. between is hospitals general that Medicare private little and payers negotiated is payment do private For bit reimburse more and what usually hospital payer, in it the

that from So they also also we payment is viable. believe private that perspective to the the are payers, when hospital authorized, economically

TPT So the now, question the a it’s TPT about the duration. known actually. – our fact for Right is

the in expires TPT end Our of XXXX.

for they mentioned still proposal this year higher and code a half consider We have to payment still companies by a path huge CMS which their we with So are they our There a the that and ours. go asking for public like to outpatient support for creation but first of a it, a CMS, also down couple they filing most step. this don’t this systems, is the In process. started therapies of paying other of opening recent have this It’s effort. comment. public joined are that request

code $XX,XXX, a new we year be we in around your you will for worst-case forecast year for course, TPT to case a scenario I our and a for we’ll ASP late receive back estimate, with case that’s not. don’t $XX,XXX, hear add waiting, it, to scenario, Of in Nevertheless, put early now. in and it why where a the the In in we’ll a the permanent our and device November, even your code if hospitals scenario. an stayed a we revert here? see there’s pricing to repeating $XX,XXX the do Jared absolute CMS, which still anything will would final as the Jared, comment $XX,XXX. in our we from on say eagerly we December or to be and make sometimes have will me future a decision at will and have good therapy, get new code, we viable that In have if a we TPT selling worst I to an maintain know us, would right $XX,XXX not economically you, without and ASP for of still

Jared Oasheim

that in did here answer it’s topic. about – question your Alex, a complicated

Sorry long. about going

Alex Nowak

Yes. Thanks. No, info the of really appreciate all I that was perfect. here.

Nadim Yared

Fantastic!

Operator

our Please stand question. next for you. Thank by

next with of Canaccord. line William Our the comes question Plovanic from

Your line is open.

William Plovanic

evening, Good Great! thanks.

thus main the account that you the in we with you’re been with and build-out I accelerating expanding you’re pretty saw getting have methodical acceleration org of you onboarding far. seems the like new the is, staff, Kind your account the it or on Just was plan doing on quarter, (a) current you’ve I to that. know of org and the wondering, like know question existing additions do new either commercial commercial you faster?

the account As always it you’re know like to point, to starting question, I repeatable, at it get seems least that onboarding? is with reproducible, you and ask Thanks.

Nadim Yared

Yeah, us. hey! Thank you for joining

a be seems and some to The opportunistic to Yes. rinse but planning being model to you situation chance this territories is accelerate? is quarter, we know hold and be three we so. a yes, So when seems it Are we repeat and to adding continue opportunistic true go. repeatable, see situations? and seems it are be No. to plan It to we’ll in to of our every be seems scalable

William Plovanic

covered Okay. I if And or this was don’t then know not.

– see – the you see if M&M to provide did Just to data? going going we’re we’re when

Nadim Yared

of and need, are Q&A. mortality and end the current in year, the that the Yes, events before year a as this of XXX first very likely all accrue XXXX. And we still of morbidity the will happen unblinding reminder, this the possibly not was of this events first We end XXXX. to covered half quarter this expecting in

regarding cone and the moment schedule will get of comfortable date the that closer about will the of date, the the to of uncertainty communication do a the It feel is we comes as a public when exact narrowing. we unblinding. Now, sequence we unwinding, about

Now If you’re a about mortality talking whenever hospitalized is Why? patient hospitalization. matter. and and long it’s a a this it’s morbidity, trial, complicated

Barostim month admitted a management patients did medical who heart event and event, that it, for takes resume. about think failure So to a receive not is a

until is and adjudicated patient the the happened, let’s full when get event of that we to before before possibly all the wait You our has in know, year will the a And the of wait right, be to is the data end data, what been and date towards some we the we process. have time of this fashion uncertainty the you the the data, the it. discharged event, all communicate mentioned timeline a have I occurrence will earlier, to I Bill, position data of all primary hope, time in has blinded the becomes Even and exact unblinding collected, of data is that that by the been creates month. as at until the between of look committee

William Plovanic

taking Thanks questions. for Great! my

Nadim Yared

Thank you.

Operator

now the I Thank for our Yared like turn to today. would to remarks. closing for back Nadim you. question-and-answer concludes That session call over

Nadim Yared

progress updating on you imagine, for thank you and on your Have our joining evening! a again operator, appreciate we our next support can you do look call. Alright, everyone earnings thanks as us our great second to we We forward quarter for update. – and ongoing

Operator

gentlemen, today’s this conference call. your for Ladies Thank participation. you and concludes

CVRx (CVRX) 29 Jul 222022 Q2 Earnings call transcript