Nuwellis (NUWE) 7 May 242024 Q1 Earnings call transcript

Good day, and welcome to the Nuwellis First Quarter 2024 Earnings Conference Call. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to [ Vivian Cervantes ] Investor Relations with [ Gilmartin Group ].

Good morning, everyone. Thank you for joining us in today's conference call to discuss Nuwellis' corporate development. and financial results for the first quarter ended March 31, 2024.

with as are CFO. well myself, President Jaramillo, to CEO; and as addition us Nestor today Nuwellis' In Rob Scott, X:XX a.m. At quarter Eastern for released has ended first today, XXXX. March financial XX, Nuwellis the results

have investor on company's you visit page not release, its earnings If please Nuwellis' the website. received

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

on overview New our our everyone. update to I morning, and Welles Quarter and an you, Thank today's good performance initiatives. give first Conference of Welcome call, XXXX First Vivian, will strategic provide quarter an Earnings Call. On

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

a driven XX% growth utilization. increase XX% again the Our way in by once was pediatric customer which with consumable revenue led category

to for grow to pediatric Revenue critical category, care our our in compared acquiring XX accounts FDA customer total months X XX a accounts continue accounts category new flat. past was prior in XX We of XXXX clearance. over the customer to

grew by was heart lower The and utilization XX%, and consumable by which console decreased utilization driven revenue failure However, by X%. sales.

pleased year. are QX utilization in represented a to to signaling therapy XX% continue total grew We adoption. the revenue, see of trends sales to healthy last which XX% compared strong Consumable consumable

consumables unpredictable continue sales We to of the accounts. cycle sales strong capital with the our hospitals balance in

experiencing program sales to capital budget than [ rental constraints customers provides year, last solution expected. treat lower to were with alternative Similar an capital our Aquadex quarter a Our first with capital ]. to patients

of we accounts of our as robust. expect target XXXX, the year However, in new second to the pipeline capital as throughout increase half sales is

clinically priority who patients key with and Aquadex of failure clinical are to of the in growth delayed Conference, are evidence and March. A days. Conference hospitalizations recent We diuretics. including at The of continue unresponsive heart strong because clinical Aquadex the reduction Aquadex events Therapeutics XXXX using economic known of THT new to of failure treat to heart failure trial the the XX result of use our system is clinical session. a statistical This in and the in fluid reported clinical and confident our heart increased efficacy technology data and the developing breaking early awareness significant for momentum at as also overload demonstrated the data

growth base our organic the to business, to forward we addition category. In in steady pediatric fast-growing new in product look our sales

pilot progress our details Aquadex program, utilization DaVita will [ of the I next. In provide addition to which we ] expanding as more

from centers in accounts a has rate it condition. Nuwellis HDE preliminary for use other Medical SeaStar medical [ while in unique pediatric patients dialogue to simultaneously approvals ] commercial ICU pediatric engaging acute by our with ciopheretic Calimmune recent pursuing device IRB survival QuaLImmUNE ] aseptic ] and in sepsis product key or behind The institutions. demonstrated X technology XX% a U.S. injury extension serves due children impact new to in [ believe hyperinflammation. We received population for development introduction. begun February, have expected potentially or this with targeted patient look license updates product kidney will to [ exclusive In its we branded progresses. or and has SCD, FDA collaboration the providing Qualimmune turning as forward have positive the humanitarian continued selective in and Now commercializing and for device with this distribution deadly rights, we on which

] pediatric kidney quality We on along continuous product Vivo is qualimune our small for [ and kidney and believe complementary value therapy CSTAR X the the [ meaningful ]. We, also device growing products have this malfunction. our together development kidneys. This add without children life of neonates ] [ born branded portfolio patients overload with those a fluid these disease. nephrologists, or to of device renal with issues believe impact device, replacement will survival improve products with to many of pediatric will pediatric and we of positive Kidney Medical's and continue

agreement pilot ]. the our DaVita of We continue supply [ collaboration to with advance phase and

selected are the clinical DaVita for ] patients accelerate heart As diuretics to Aquadex pilot when as help Aquadex therapies the adults, could markets. Pairing well clinical infrastructure therapy this adoption of collaboration [ reminder, potentially ultrafiltration with a U.S. ineffective. in failure allows as DaVita's

made in early heart during ultrafiltration patients therapy at X using the to of for announced positive we pivotal Michigan, and Henry Ford We forward with for launch specific academic the heart look assist heart failure our quarter. In information Aquadex hospitals have Henry failure, clinical Based clinical more heart Ford of is recognized April, failure in the of ventricular in transplant part Health introduction one as results. excellence heart reverse very study. We the devices. Health centers left leading failure providing nation's

forward of Michigan. Dr. them in honored hearing as We I be Jennifer failure study is working in one ], her the Rob cover the largest the this failure discuss program to [ heart the efforts, to XXX program of the offering look are Henry to Michigan with findings Ford results. multicenter Head the lead and heart randomized will progresses. We as study in now trial and like intervention. I'd only turn first quarter currently patients it site our is to their have to involved financial

Thank morning, you, Nestor, and everyone. good

for X% driven first shipments. XX% decrease QX to by over increase offset a was financial $X.X in representing in period Turning console million, Revenue by the a the utilization, prior growth the year partially consumables results. quarter an

the expense in prior to the million reduced compared XXXX. head quarter, and and in in administrative decrease year XX% by of margin million X% were driven compensation-related general first lower of decrease increase by The $X.X sales. Total revenue was Pediatric current year and of in failure. in Gross to the was utilization. offset margin console quarter quarter. due by consumables a increase of decrease driven corporate category heart results expenses. the a in manufacturing administrative a in SG&A increase quarter year-over-year. in XX.X% The QX, sales customer XX.X% XX% Critical pediatric improvement period. Selling, gross first was consumable in flat Care to primarily Our had primarily XX.X% higher was consumables for expenses strongest the the a was margin experienced in growth volumes but with in a utilization compared count first were $X.X as revenue

equivalents in to operating approaching as current XX% initiatives efficiencies. We anticipate $X.X decrease million forward First approximately $X.X related concludes like period-over-period million to the open and The in cash $X.X the quarter $X.X the million compared period compared a to of $X of a loss of shareholders share half first sheet. On development we in with on research million cash per for the the prior an was the loss with to $X.X $X.XX underwriting closed the attributable remarks. operating XXXX. and Total million improvement. Net Operator, $X.X to resulting million a $X.X quarter the shareholders proceeds operating operating for period, in our public to first continue and calendar implemented quarter no and the of the to We of XXXX. was compared through ended common drive to period-over-period attributable quarter loss now balance in call discounts in of was were million April first loss prior $X.X a reductions million significant questions. to same we the year in XXXX to quarter, or Operating savings and expense an carried with to as offering offering. This or underwritten million in period. year. to of commissions of before rest million deducting efficiency the due net cost year compared debt measures million would share per decrease the XX, period quarter was the $X.X expense in common Nuwellis second early expenses $X.XX prepared gross $X.X the first loss

Anthony Instructions] Our begin Group. comes of question from We Vendetti will now question-and-answer the Maxim session. [Operator first

agreement. was Nestor the C-Store on So just curious distribution

on I expectations your talk -- the for your at if or by Have wondering just And year, are end call. on have basis opportunities. mentioned could cross-selling a salespeople you also what's they selling the it? You all the the it, do trained that's started of terms it just in talk quarterly was about on where about you of that?

to starting train -- our have to initially personnel, have clinical phases. started X we're Anthony, train target education we questions, Good especially we specialists Okay. already our

HDE we is phase pursuing them first are the per The each X centers, in IRB one and of requirements.

been of from have sites are first We terms into start personnel our very all very [indiscernible] XX about to up. X would involved along which devices combination. next be our with perfect these that the centers then ] of be coming us cross-selling, they these personnel. Once clinical we have because the move a [ centers, that in the I -- clinical with we will educated, this -- expect good opportunity together have the would Calimmune identified. in X is X talking for technology And be

pediatric ] CRRT device. will pediatric device be dedicated a Our dedicated is [ cytophoretic and Qualimmune a

the combination be the and terms of are quality life neonates. going lives in of of to the children fantastic of So improving saving X and

little you Great. capital generation want place factors are about you pick that equipment equipment year, or up. give us said that a -- Okay. a also reduction I Maybe consumable year per to sales sale, that? for to just cost is before sales how when equipment determine during the questions. works. that have you capital capital equipment what a expect that talk And have capital I couple into what process the color the a expected

that with ones the are to saw all, the post-pandemic. we situation, year. as companies, of Okay. just sales of reported a all I first and as was capital lumpy been not the have the our acknowledge them, being of only last having saw sales just want of part X low equipment that earnings Well, in one capital first the they to I very constraints release capital GE hospitals due that And

of different specialty So how per depends consumables a lot units use the is that in much the the using a Aquadex. on in hospital console utilization hospital, the

centers ] like in in in XX have they patients anywhere or that Washington, D.C. consoles and New treat month, MedStar ] Manzana to [ have [ high institution. X We the console, a -- this Washington utilization City of they XX, use this XX from they

high have X as have as quarter, consoles treat quarter patients they month. that low and per as X only per probably also per institutions as XX or five, We or

driving prescribing in the only to the is different factor patients the So how the therapy hospital. are here doctors the much

helpful. Okay. reduction. cost switching the And gears to That's

there either costs programs not, did this reductions those was salary that any you to addition continue so think targets? for year. if have And to in how scaled XX% reduction to number? a I and about forth. back just XX% or Were get you there in hit

mentioning that are initiatives been over and the failure years strategic initiatives, through sales pediatric device. heart X the dedicated marketing, Well, have reverse and BVN we

most. pole were a of in The phases the Vivian, are using is development of lot not for affected. development final we -- was and consultants have and that was third the that on the the first the part we are the the tent, X affected development, that, the and And software one, in affected initiatives software tall not been

Okay. cash. the And then one just on

offering I So at was end April of proceeds, quarter, million on for the gross the $X.X XX. the $X.X the believe, million

was So balance the that sheet? that added range proceeds of to what were your net

$X.X approximately million. Was

anticipated quarter? per we is Okay. the try what estimate second Great. trying quarter. put rate can Obviously, cash we the burn to quarter this cost to an that you're for rate with are all do in have Internally, burn the here, together, that you reductions as

Well, Calimmune enough this that a which the have execute to the milestones [ change we until we early APC last believe time potential have would allow to of commercialization which X and X also the device, have those are ], on we key financing with the be cash net expect from to ] received DaVita us code. starting milestones fall, patients this will for soon in we on continuing that proceeds pilot reimbursement a communicated that execution be [ will treated

So execute milestones, once then market another back if we need we X those and go we on do can to. to financing

the question-and-answer Nestor session. for conference remarks. our concludes to turn back some This over like I'd to concluding

hospital of expenditure by adoption confident XXXX, increased will in are that the year in further capital of strong as We therapy increased result led a awareness headwinds. efficacy and our Aquadex growth momentum helped

Nuwellis progress product as agreement from exclusive Aquadex of conference, demonstrated quality in fast-growing sales thank like commercialize as nurses and to you possible patients our Medical Without as removing we Sister by and the mission, program. I to our support, we [ the Thank advances care be life. I THT as Calimmune which with [ In is productive is XXXX. of to would ultrafiltration new want of pipe suffering the lives from physicians, addition, in expanding transform and workers the Nuwellis not stockholders to to [indiscernible] fluid achieve the a enhance addition overload overload. DaVita our for goal look able to conclude we [indiscernible] ] and support participation health to therapy lives from key of forward method look fluid our all many patients suffering highlighting SCD the category in ] in to fluid transforming your patients your distribution as fluid from from we utilization overlook. patients it to superior suffering field. reach would their pediatric for forward and we employees, stakeholders, excess by our is the

conference you today's for The now concluded. has Thank presentation.

You may disconnect. now