NUWE - Earnings call transcript Q3 2024

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Operator

Good day, everyone, and welcome to Nuwellis' Third Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note this call may be recorded. [Operator Instructions] It is now my pleasure to turn the program over for forward-looking statements, Vivian Cervantes Investor Relations.

Vivian Cervantes

Thank you. Good morning, everyone, and welcome to Nuwellis' Earnings Conference Call for the third quarter ended September 30, 2024. Instructions] [Operator

joining results to ended for XXXX. for developments Nuwellis' September conference financial and the today's you discuss call corporate XX, Thank third quarter

earnings addition X:XX Medical for XXXX. company's Officer; Nestor please well Investors as financial today release, CEO, In results our the John Time as with Those CFO. today, page Scott, not President revealed At Dr. Chief quarter Nuwellis' received Eastern the who and are the our Jefferies, Rob myself, to a.m. third Nuwellis' Jaramillo, visit have on us Nuwellis website.

events now filings I statements. Please these that, Securities market the will with statements and During over our company's like of current refer latest and to expectations today's under call, upon Exchange these making All or statements predictions no not based material of based XXXX. All to implied the or the as the today's estimated Act current anticipated those XX-K. With statements be company statements. All Reform These company call forward-looking and on during statements our to including upon uncertainties the of forward-looking could protected information, trends in future actual call Any place as the statements. Litigation will be assumptions. results made discussion update forward-looking statements Accordingly, available involve reliance cautionary to forward-looking statements. relate various Securities and well you to and results risks Nestor. obligation Private are undue are Commission, performance the or forward-looking that cause are forward-looking the that risks estimates and events, these to materially turn assumes from statements by differ statements. or should would

Nestor Jaramillo

Chief to an provide performance Quarter I community a Thank Medical our Nuwellis a and Earnings overview Call. Officer, recent Dr. On Welcome the in call, Jefferies, of an update quarter strategic setting. the and on followed initiatives, everyone. our publication real-world summary you, XXXX give provide will today's hospital Conference Third of who Nuwellis our on by will good morning, Vivian, of third efficacy

Our the year-over-year. before questions, will my $X.X Scott for detailed followed financial up closing XXXX, Rob for decrease opening Financial of then million commentary on call results remarks. Nuwellis the by our revenue Chief Officer, a third quarter in X% generated provide

we sequentially, over However, X% QX. grew

the last category surge experienced month, saw lower summer category pediatric adult the year, volume patients of customer of our hospital networks of this While of in by our a business treated X in opened largest driven of the during same pediatric quarter including compared to new revenue Florida. a XX% one the quarter, accounts

experienced We in a sequential also pediatric improvement centers.

account, the we In pediatric additional accounts. also adult opened addition to two

ultrafiltration our differentiated market to We Aquadex are drive our body of continue excited evidence. as clinical penetration we leverage of to therapy

patients For reflecting and lower down failure volume were summer lower XX% the of and generally sales, reminder console the the on our customer of respectively, utilization heart and category, consumables treated critical months. XX%, during care

discuss information Jefferies? build and our to initiative, this initiatives the the would support of may evidence that standard order Jefferies clinical clinical to make therapy last guidelines. In growing body to Dr. over practice. been medical now Dr. get to the this clinical and day-to-day One X of care I it broad like years have to of our evidence of key our in turn to addition body impact latest this clinical the into have society for in of

John Jefferies

hospital diuretic significantly effectiveness readmission heart setting. morning, the problems otherwise of good resistant who Nestor, we XX-day failure, compensated In a of you, August, treatment Aquadex hospital with for to are demonstrating Thank acutely publication and reducing in and patients cardiology, in a community new current study rates everyone. the announced and

failure this as senior to program refractory typically treated, from the reduction, along occurs community-based decompensated I controlled than trials that of to preselected patients showing very need everyday of and the vital of analysis in This with heart clinical outcomes volume demonstrate weight certain pleased a would the and author for these how benefited As is strategy regional as therapy. The often like highlight can acute paper of have hospitals patients the Aquadex on and to patients benefit. I that setting uses of expand nonacademic for use study real-world function this cohort of randomized the and leverage academic the as therapy that outcome see hospitals group rather an than trial a be Nuwellis' Real-world institutions. setting. now center significant we as as effective be in hospital because the we these was some to community-based it renal types a broader of powerful shows effectiveness patients. this to remarkable ultrafiltration more loss ways, a data which is stable data Aquadex applicability

program Going of deeper showed and decompensated decompensated with findings, favorable this a failure acute heart readmissions. There XX-day failure early, shown can compared in therapy initiation numerically programs as of preprogram achieved study's X.XXX. heart [indiscernible] result, fewer that statistical p-value are reduced into in after system initiation, acute the it readmissions Aquadex the to Aquadex form

decompensated significantly However, of at p-value a heart there fewer acute significant XX with readmissions statistically failure are X.XXX. days,

test Additionally, XX all creatinine, of significant of patients mean volume ultrafiltration a measure renal experienced food function decrease in function with X.X a used and mean significant patients weight as had Notably, significant liters, to therapy. hours a kilograms. loss loss stable reduction, no X.X XX serum kidney and of a with change

practical for important can successful unit. reproducible, a be without heart program implications by had the demonstrating study Aquadex that failure is and cardiologists the a for failure clinics, heart Finally, general dedicated coordinated need

this to X/X turn discuss has And results. We like in which I'd increase the financial The to over of to becoming to enroll care. REVERSE-HF trial, and welcome by enrolled Rob continue third Q&A support provide data designed contemplated quarter to the new patients of on patients session. awareness help during is the our the any to now questions the protocol. I standard evidence study

Robert Scott

and Jefferies, good Dr. you, everyone. Thank morning,

results. to QX and decline Turning X% $X.X Revenue the representing million, growth year was an over for a the period. the quarter X% prior third sequential financial

XX% one compared new Florida. customer with category as year one Aquadex to a three of pediatric we surged centers, increase networks a within pediatric to hospital ago, Our expanded largest which our is in of the offerings

and quarter XX%, heart and prior sales. Gross of XX.X% manufacturing the in year-over-year in quarter volumes margin quarter. margin of down quarter, categories XXXX. to margin gross administrative care fixed the console XX% due were The in These $X.X higher summer the overhead year was enacted also the critical third was Our third through in of second decrease expenses. Selling, XX% efficiency expenses as primarily driven for manufacturing lower respectively. half primarily lower and decrease by of general consumables because $X.X XXXX. third and and to realized customer was a to are of declines SG&A the months million approximately and million of failure consumables were in The utilization compared compared XX% the initiatives improvement

to to compensation-related was million enacted in the operating million million, expense year or in in million to realize to primarily an operating prior loss as XXXX. Operating period. shareholders approximately loss $X.X shareholders development for and of initiatives we prior year a and expenses. Total $X.X quarter gain research common loss second of $X.X the the of compared savings of third expense million, decrease expenses consulting the $X.X in the decrease fees third income $X.X the quarter the to R&D or a period quarter, in XXXX. continue due $X.XX in The attributable quarter per compared to operating $X.X share, a the were net $X.X half improvement. Net in million XX%, compared quarter to $XX.XX per reduced period, a to $XXX,XXX, resulting was third of same was loss million was XXXX period-over-period $X.X efficiency in in attributable of a from common million, of compared share or of as Third

period million equivalents revaluation with debt income in liability, benefit. We the sheet. cash of improvement a with cash quarter prior on in million Third result the and $X.X of ended was no quarter third resulting balance primarily the $X.X the and warrant net a

Our $X million, and August the registered NASDAQ July and offerings under priced third approximately direct of the in market at the $XXX,XXX balance proceeds respectively. quarter included rules, cash with gross

of we call As October. This like a and in mutually terminated we We the our concludes would in the settlement agreed end remarks. distribution we Operator, to the license of previously they Medical, SeaStar $XXX,XXX disclosed, to month year. received to $XXX,XXX questions. in calendar open the agreement by resulting now whereby pay prepared our Nuwellis, October, approximately with

Operator

ROTH. from question a take We'll Jonathan Instructions] of Aschoff [Operator

Jonathan Aschoff

economic setting comparison the an ultrafiltration walk I use that now the -- these hospitals to make ask to the would way versus different would same outpatients? you they and reimbursement, they us heightened a profitable -- through in the Aquadex way like doing now the the make outpatient money would profitable of for can money given

Nestor Jaramillo

from that to inpatient, a in to hospitalized, Right may anywhere the provided Very remove X take days is Jonathan. and little This patients. explanation. X takes only the question, long fluid these ultrafiltration good now, of the it way get and is patients

to because DRGs, be X of a the probably and reimbursement the Any $XX,XXX. DRG the one are in the big heart about -- And treatment the is compensated reimburses then failure. you treated for that of incurs X heart a for inpatient is heart those cost hospital, there the If loss, failure, $XX,XXX. patient is DRGs of highest failure, hospital

reimbursement, now the the need be could outpatient It observation the incurs So doesn't the a even hospitals setting. hospital. patient ultrafiltration or loss. With And the in can on admitted ER. in provide be hospital to this an the in unit

me, $X,XXX is day. now X,XXX reimbursement -- the Secondly, excuse per

patient So it if that be physician fluid then will amount days every to day. remove the the recommends, needs the that X

take and is observation coming of So $XXX which again, the patient, treating these the -- can given And out a the days day X make of hospital our cost unit. the treated [indiscernible], patient patients. now, anywhere for from in the the hospital can $XXX,

the more be the And hospital so therapy. therefore, would profits would -- have from

Jonathan Aschoff

Right.

the see replacing those for have totally population reason? inpatient there don't So for other this to you be some that would

Nestor Jaramillo

could the envision ICU patient in in Right. -- the exactly, the in using unit, replace in hospital needed the the treatment admit to it De-congesting ER ultrafiltration. or replace will patient We or the ] the patient hospital. the in therefore, inpatient the admitting not of observation [

Jonathan Aschoff

Okay.

outpatient these two So use. it more can long going if versus some money, might any as difference harm, doing I between can. there dialysis Because they machine mean, no of hospital make benefit Aquadex sort meaning to justify in then, is the actual procedures, medical it's always as

Nestor Jaramillo

in in the assumes hospitals. mention get or more profitable forgot also some then most treating be with that would within outpatient the CMS one If the by believe private We doesn't patients to patient inpatient. Correct. of payers. for other aspect patients penalties. hospital days, I the heart XX And it decompensated the treating failure readmitted is And paid

the patient that's savings was So not another admitted. because

In terms mortality the hospitalized rate the up. to of the patient, is what documented patient, is it that condition, well regardless patients of that the get goes the benefit

So you therefore, to those having high by to mortality admitted, exposed don't are not be rates.

addition, the patient would the that, go X be hours then the to and from In and anywhere X the home after can next treatment visit. just schedule -- patient

patient, So also and quality much for it better of a will the be life. better

Jonathan Aschoff

Okay.

-- what's never into was mature that hoping to DaVita, then into? why the matured what's of it wrong crux what So with

Nestor Jaramillo

DaVita, we question. that a started When internally good had That's And have a we debated we champion Jonathan. with in organization. reasons. were what the conversations Yes, the

got we and team. as the soon a then we champion were different agreement assigned promoted that As signed

needed that personnel. target they we by staff very that happy right were good not in did beginning, lost were bit treating there. Also, We patients So the the Nuwellis, DaVita their customers did -- inpatient. not They momentum of centers and a the target centers. of the at we little were the

get too and So pivot with for accounts took provided went and to that use then were And a then issues to ultrafiltration. with by to ready DaVita. them we long capital They little had familiar ultrafiltration personnel. we budgets just it

Jonathan Aschoff

trial REVERSE-HF time about con I'm lines you so All said right. something sorry, did, you commitment would already. And I if the had that? enrollment maybe you data? percent when can Also, we and please expect calls, reiterate

Nestor Jaramillo

of of a the follow-up have there after rate finish to by current would period enrollment we the is ready then then the expect middle and be of to analyzed And At the we end by XXXX. submit the XX-day data that, Right. and enrollment, XXXX.

Jonathan Aschoff

Okay.

mean to the okay, FDA, You -- you mean?

Nestor Jaramillo

guidelines. to FDA. for to not in them not Well, submit the is To include -- publications, FDA. medical societies not This and to I'm to to the Correct. therapy sorry, this their the to submit

we and results be the expect, Assuming, to very favorable.

Jonathan Aschoff

Vivian you give an did progress? update And for

Nestor Jaramillo

Yes.

that XXXX we protocol Vivian. IDE be continue the estimating the trial. the We would start on already an the phase clinical of would have in-human ready development It FDA end to trial will FDA. be we're be study. an we the with by the that of agreed And And

Operator

[Operator move to Maxim Group. We'll of Instructions] next Anthony Vendetti

Anthony Vendetti

rates, on are new go-forward higher critical are ultrafiltration this right? in phases, specifically, substantially into you effect failure these which X heart your to capitalize organization XX/XX, correct? internally Pediatric, the you with customers? care how And So What's go addressing this for preparing how are and the plan? all

Nestor Jaramillo

morning, reimbursement. Well, triples very we're first new excited Anthony. about Yes, all, this the that good question of assigned and good code

sit in they about were set do hospitals perform. what either ultrafiltration also order And to called, come and centers CMS those then in those requires patients get able centers, coverage is preparing, outpatient territories therapy the are ultrafiltration And it ensure in And outpatient have also, And to local ultrafiltration were hospitals, by identifying that sets. a in, We setup. Requires do to in the used that doing and need the accounts, chair administrators payers. to there to setting. private the back the setting. down that in those those from we're XX up, XXXX, be going also, those

helping is making get set ready the as So ready well be reimbursement both filed. we're as hospitals the sure to on getting up, that

Anthony Vendetti

higher to place? reimbursement, you And do hire adoption? that you accelerate like a clinical salespeople believe point, or this either you to people at the need feel may this with try Okay. in of all you have the you do couple personnel Or

Nestor Jaramillo

outpatient now, the we Right these in we're in that question. so Good the place ultrafiltration haven't sales doing, territories can with those Yes. we past, we territories. X specialists, have the Most with -- and and reps start hospitals those clinical in covered. of

not the outpatient. add anyone need would to with started in field to we So get the ultrafiltration and the

some expertise comes to to in going reimbursement are bringing the look We headquarters. into when it

Operator

happy [Operator appears questions at concluding it have this further any return conference Instructions] for the to be hosts And I'd no that we to our remarks. time.

Nestor Jaramillo

operator. you, Thank

and Aquadex steadily business momentum in to the categories. pediatric the We our customer continue new with awareness efficacy supporting care will removal ineffective. the becoming growing by business a believe these on of adults We clinical our see in evidence Jefferies, Aquadex for in results, and fluid the positive opening when are increasing have described in ultrafiltration, supporting as and Dr. our in clinical impact accounts diuretics standard for of

of received early level, reassigned from reported company were announce notice most the we week, Medicaid -- CMS, As Aquadex we of last outpatient administration pleased as and ultrafiltration to reimbursement will also to treatment. the known center that the the and code therapy be consistent services, the of the ultrafiltration cost with of Medicare the

We per a for line reimbursement growth Nuwellis. rate seeing anticipate to So are from XXX%, chapter increased $X,XXX fee effective $XXX With top XXXX, this January X, opening increase. facility this we reimbursement, the will new from day. increase accelerated

announcement a increase reimbursement of reflected point XXX%. a the clarification, as prior As

fluid patients overload. as able reported your support, the solicitation. I as $X.X the to exercises from raised million lives achieve suffering well we and last physicians, gross for proceeds Without be participation warrant warrant and advances Thank early health company employees, to key through from and all your of and in thank Additionally, nurses patients workers stockholders, would the in inducement want care in you stakeholders, support. the transforming a field. as not week,

Operator

conclude does Nuwellis' Conference Third Call. Earnings Quarter This XXXX

everyone, disconnect have now your great may day. and a You lines,

Nuwellis (NUWE) 11 Nov 242024 Q3 Earnings call transcript