CRMD - Earnings call transcript Q4 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the CorMedix Inc. Fourth Quarter and Full Year 2023 Earnings Call. [Operator Instructions] This call is being recorded on March 12, 2024.

I would now like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

Daniel Ferry

to Full welcome Conference XXXX and Call. morning, the Year CorMedix Earnings Good today Chief Joe CorMedix. the is Leading call Todisco, Executive of Officer He Dr. is joined by Kaufman, Chief Officer; Executive and Operations Chief Officer; David, Vice Mistry, and and Beth Matt EVP Erin and President Clinical Strategy Chief Officer. Hurlburt, Liz Zelnick Legal and EVP Commercial of CFO; EVP

in known to we limited following: any goals the the statements meaning including clinical management DefenCath, may company's call, than begin, future about during that statements the costs the Reform potential Litigation I other Before of Securities market future for and and are of candidates. uses acceptance are for marketing statements within what product historical Private plans reimbursement would and approvals revenues as its and are Act and DefenCath, product its launch everyone set These not other DefenCath facts statements prospects, like but other any prospects include, development forth certain to for or programs activities and of remind XXXX. uncertainties of expanded forward-looking make to, candidates; of risks beliefs, the manufacturing regarding and position; commercial expectations, financial projected management's subject

the place in with development, materially at clinical results to regulatory described intend the factors my a call the to variety available approvals update to this not CorMedix copies reliance and turn are CorMedix' from SEC's including not time, CorMedix. including, that or of commercialization. does Actual filings except now of differ law. At over from as please XX-Q XX-K, at annual undue report investors www.sec.gov to in Joe estimates not of and detail greater Executive Form on Form may go charge request risks CorMedix. Officer website should or free latest forward-looking on by important plans of Todisco, upon in may actually uncertainties to, statements. but SEC, it's the quarterly pleasure these note projections report Joe, statements, forward-looking on statements, these which and due described are related Please these or to not achieve these These CorMedix Chief limited goals the required ahead.

Joseph Todisco

Good drug reimbursement, eligible payment TDAPA as final November, call. the you and FDA the Dan. we Thanks, morning, a as thank U.S. milestones, joining has a disease transition for key NDA dialysis be on payment for everyone, classified DefenCath achieved the of that renal receive number end-stage has earnings will renal service approval well add-on for or presented system. under by prospective notably confirmation us of the in DefenCath company most this last to from outpatient CMS Since as CMS DefenCath

April approved approvability gating for timing impact additional J-Code review reserves TDAPA information XX. currently J-Code DefenCath, for remains slated the company the X. application for for our are a setting CMS As of receipt has we commercial DefenCath X, CMS on XXXX TDAPA a reimbursement writing the launch effective outpatient The previously following the commence CMS. are HCPCS our at confirmed they schedule to announced, any and and commercial and J-Code J-Code guidance review reviewing December in which launch and we an that of implementation for and request applications That application to Those and are which our TDAPA. Both inpatient is July TDAPA toward right actively submitted remain under CMS, effective working January that CMS items of application, to and/or or July applications said, may payment. a TDAPA on from our application in in

launch meeting last care. both organizations infectious affairs We team in and sales internal week team backgrounds February. field we with spanning and have disease our of and nephrology, is settings experienced a trained during specialized built have medical of deeply the and and and successful both staffed outpatient inpatient The held the

production which back inventory part up is with accordance ramping toward also year. internal the weighted plan, in heavily our of are We the

As part track is in to as manufacturing for chain supplement strategy, in qualifying our submit to of a supply company an NDA alternative our site the site Germany April Siegfried on DefenCath. Hameln,

online FDA supplement, favorable the site the come review that of would of by a additional from production XXXX. end Assuming

expect as processes. trajectory modest On hospitals launch inpatient in fairly ramp and to we about X are inpatient their launch think the systems As working do through P&T respective health quarters our for the April, the be inpatient we over the utilization process health review first said, That with from actively and range last interest particular significant months. X through to few or system a we X midsized systems. the for months P&T are process the formulary average, and hospital several received working over P&T large have can

calling as begun field-based our health hospitals We have to account expect prelaunch to discussions. months intensify just coming systems managers key in this contracting on effectuate and activity the

that by operators, the resources run midsized We base uptake, we net side, for as cash forward the we demand, our assumptions we large end to advance. Based can upon discussions this are case rate sufficient these and coming December company and discussions have achieve current productive months objective. outpatient On we XXXX, a to case on additional base continue providing our look dialysis assuming we believe internal to with the forecast the DefenCath hand of for breakeven achieve to continue and updates have believe achieve able profitability pricing to on XXXX basis over reimbursement.

than DefenCath of we available to uptake we sources alternatives requiring capital, financing and several our nondilutive the internal company, of financing. including launch the be have believe projections, more slower should However,

company's addition gone all affairs organization. CorMedix these excited the financial into has as to thankful our expansion, members of and has am quarter that with latest launch. for all discuss team I company bring our what accomplished I over new patients. I and and to months the turn size year-end the in over fourth and DefenCath other field to to in those Matt grown medical we've am now the preparing well results like work involved position. financial and the for anticipated the commercial hires of Matt? and would recent additions call to new across sales as of the proud

Matt David

and activities decreased XXXX. Operating to I financial good million, read fourth full in you was of million the loss increase in I quarter respect approximately year manufacturing expense filed $X.X our XX-K annual in higher net of compared morning, costs financial to as approximately net on $XX.X compared share to update DefenCath report activities of cash today to $XX.X with studies personnel per the primarily quarter for results. With XXX% Thanks, $X.X approximately in am loss XXXX This by quarter period related expenses of of fourth pleased costs or the with the results. company to expense $X.XX $XX.X CorMedix' overview by more and with increased attributable share to DefenCath. approximately to XXXX fourth Joe, in by report the to XXXX to XXXX. costs driven The complete was and compared XXXX the in as everyone. on driven $X.X fourth $X.XX in an related full fourth an personnel hires due has be with its position. quarter urge The XX% R&D respect of Form financial XXXX SG&A primarily results, XX, our in expenses XXXX. due prelaunch XXXX XXXX. in and contained to in additional discussion ended of XX% higher hires XXXX XXXX here an the QX quarter our new well increased our or quarter to fourth increase compared increases of a December to in year launch in the to provide year increases in to and the our million results compared to the million a fourth of million financial for per recognized in XXXX. million with primarily for loss market was same related research million $X.X quarter decreases costs information

expenses December lesser others XXXX to $XX.X result research in XXXX. decrease launch loss in recorded XXXX. studies additional operations $XX.X compared compared Total CorMedix operations commercial The as of operations the XX%. expense medical an $XX.X increase used These of in costs we of increase period R&D million related $XX in position in has the by in to and the million million operating related is in primarily an amounted legal prepare increase increase of perspective during by same personnel significance The expenses XX, $XX.X to in driven in and increase of in cash attributable of DefenCath expenses the affairs a increased XXXX period. We SG&A hires by million primarily a to sheet million, million in million marketing as for among fees with DefenCath during for from an operating an of full in XXXX. increases and equivalents preparation quality increase company XX% $XX.X compared net a increase the prelaunch balance the approximately driven primarily in to an to approval. launch XX% personnel XXXX. an increase in cash of increased related XXXX, the remains year a of activities of the company activities used costs by primarily costs with were $XX technical partially net in DefenCath with market manufacturing in and commercial net for in an offset, to to as prior April. increase expenses as cash a expense cash driven and its for good and

the least operations commercial end $XX investments operating previously, may in and XXXX internal the to gives for cash, from and cost closing our net projected occur uptake, assumptions a through are million of base of range to company rate $XX to to our driven XX remarks. the we we and cash our launch the flow anticipated the support discussed turn achieve assuming short-term DefenCath. to basis future believe anticipates to ability we equivalents, to the the which the December Joe the We profitability, commercial launch CorMedix to at for Joe? operating of and able now expenses fund to back operating and pricing million SG&A, over have DefenCath DefenCath. launch expenses, infrastructure growth especially XXXX, company months of around run As commercial by on quarterly increase demand DefenCath reimbursement. I the call case of will by XXXX, cash for expect fund given

Joseph Todisco

of and of potential any discussion inpatient FDA we to laser request CorMedix engaged the actively meeting potential indications the our and launch on our about in with outpatient for is in for of we is a and to beyond. upcoming future care Thanks, pathways settings customer March, expect optimistic XXXX. potential April, the respect DefenCath, to a Matt. launch meaningful focused clinical around XXXX on discussions is and targeting in submission With date have FDA by post-approval mid-year end are both

As I time. revenue intend do provide this earnings we to not earlier, or mentioned guidance at

guidance when revisit if may we However, appropriate. and

continued I in support take happy appreciate CorMedix, to and questions. I'm everyone's

Operator

[Operator question coming of from the Instructions] We line Citizens our first have Jason from JMP. Butler

Jason Butler

the on progress. Congrats

you you get could the Do out when we then committee you launch and early meetings get expect do just detail the about at secondly, decisions should scheduled you use you before you and P&T have should you think little I meetings the on these you're the walk first bit utilization committees. how Just as point? through can can making this give get hospital think -- committee mean, those within hospitals get this think do wondering -- more the us the And And first meetings? any if approvals. we with any you of approvals. a progress us

Joseph Todisco

Jason. Yes. Thanks,

have process, So from P&T a meeting do that meetings scheduled. some we are currently

quickly be But think and the on how to would and quarter. let's a -- comment formulary. have I outpatient on due I for on way will right, can't inpatient the second. timing I'll whether in the ramp, be would process. a scheduled, say, second don't number I Yes, slower a to expect that that the even We adopted P&T then be move they will it we we of touch really about mentioned

we a we of think a we the and inpatient gradual midsized potential short-term it that ramp, a outpatient patient when in-stepped, of to focusing see customers side, a outpatient certain within kind side ramp upward those the the over on more the as long-term, we volume, then given size about lumpy, think onboard to be a would patients, kind right? starts And steady bit new move right, to the So little of the on as plans as little about initially well in fee-for-service even we facilities expect on lumpy time. be more of ability maybe MA side, customer right, more as It'd ramp. large of whereas begin

Jason Butler

Got it. And more one for then me. just

activities, for alignment? But FDA label a get just you those trials after the be other operational quickly start those In guys catheter are you trials and settings, mentioned terms to of obviously, feedback. waiting expansion or from the launch FDA in interactions an perspective, preparing position to use you

Joseph Todisco

forward quickly. the expanded if of we put for be that switch, they depend to immediate, on not certain make, that's intend be right, think right? going It's to Obviously, indications. launch going we're it or they fairly proposal the to to for flipping adopt accepting a that I those but more if not pathway. whether pathway desire are done, could not a We just longer light can then work on they

Operator

question Markets. Capital next Renza comes from from line Our of RBC the Gregory

Unknown Analyst

Congrats for on quarter. this on Greg. Anish progress It's the

as you reimbursement to thinking the on us outpatient political on DefenCath? Just date. about for composition secondly, shifts the of current segments and update then in first, CMS and current an new maybe And force affecting your to in commercial could pertains upcoming you inpatient if how the give some and are tides policies ads it field granularity

Joseph Todisco

Anish. Thanks,

deployment standpoint, important little bit care. than, year thinking those a a have bifurcation we've rather last between I team of outpatient melded migrated with and them into let's the from, from geographic than field a inpatient say, being our X somewhat settings a think, So we've and more split teams, one between

more essentially contracting on manager of Given as it's reimbursement a key medical from a sides the account than from skill knowledge the same role the of care nature of rep, set both a the standpoint.

sides The dialysis small in a is large both on or operator. hurdle product adopted the be a system, it getting really the system

of But where now, So look XX We for field. we launch. we're think into at to grow XX, the Certainly, and have through, right team really may in it's the have experience X that over range. a experience XX right the right White the standpoint, with our to place. From staffed What in we hard have Biden gone that's may happen. right, now, political tell, CMS. time House comfortable years right? with with we're We just sufficient about we're

years X experience Trump past have also of We with the Administration.

we're who time, it change the White this but House, at So change. could CMS of seeing really anything always regardless at in certainly up drastically not ends

Operator

Sulewski question line Our Les of Truist next from the from comes Securities.

Leszek Sulewski

you to expect shift from demand XmL would quarter the to stocking to launch? follow-up XmL which Can you, for also around manufacturing you inventory do of expected your Joe, the COGS. the ahead distribution ratio color some R&D centers channels and provide implied expect around your manage the how a And their And maybe vial? that, inpatient commercial to levels And versus levels. cost

Joseph Todisco

questions. Thanks, Les. Good

essentially from on to inpatient going a So or the channel distribution inventory through distribution, will the flow inpatient a specialty for flow side standpoint, through distributor. that facilities is specialty

get On side, specialty others the for of going will will outpatient a it be and distributor direct. some mix customers shipped potentially through

we because initial had work. issue, and label On development done the XmL our in XmL the was XmL an

a vial to time. you XmL If the product in not this was our XmL remember, initially the at commercialize intent it's but

XmL. So the is intent to a product we're launching the with launch --

see the over more faster I demand. you about depends when the think right, question it built demand is that right? right, And approval. bit one, -- this little expensed, cut right, goes, cut right? last asked So take right, slower, pre uptake earlier, If can it inventory decent a over on difficult some we may The year, time, certainly and of because demand prior you we've a amount to was that

Leszek Sulewski

it. Got

more follow-up. one Just

yes. did, you think I

the WAC to B strategy I potential follow-up, are and this that What filing more Medicare impact separate X for under you your price? potential and time payment lines the some expect on Just on guess, reimbursement. around Part approval

Joseph Todisco

I question, I'm Yes, sure not Les. thought that

So scope fall our the made under determination. determination right, were that's ESRD reimbursement we for that system. the prospective of end the payment eligible have CMS to is of stage a TDAPA, outpatient going

we our inpatient do On the side, have NTAP.

application Les? So right? clarify for be is if from So determination. TDAPA, question a the required what J-Code, J-Code might Part you all, is B separate at that the that's thinking, Does

Leszek Sulewski

price? adjustments the there any is for WAC And Correct. to a potential

Joseph Todisco

So with time, look, we product always adjustments of as but we'll move we've at the to WAC price don't, TDAPA a envision the reevaluate $XXX. the WAC launched during period, any forward. I this

Operator

comes from & Needham from Company. question next of Our Belanger Serge line the

Serge Belanger

I you Joe, it just a review to and that that expect kind also would uptake? about if through the Maybe And P&T then think you X outpatient lastly, what entails. in maybe do you year? process of can the months. process process bit the case X us mentioned by end little evaluation just take base your talk there for process or of an And the adoption walk is setting, before

Joseph Todisco

Okay.

I'm the outpatient, and provide question, the the follow the with product. formulary determination we're data for #X the to facility outpatient. that's economic So the second They're well facilities. process that right? whatever to terms and as first, at your the what certainly clinical comment put and making need you're of on a then to at evaluation They a think process They're to that institution. looking Erin asking P&T anti-utilization, medical as product start I'm going on when I looking for reimbursement able to similar going as certainly, And the a allow

are number on to to run What at asking me confirm that X breakeven. you're what you your think rate you I get X. is is question asking -- clarify, from we So can

Serge Belanger

to get and status about that breakeven pulls pushes you that at to case. the just your base you talked Really

Joseph Todisco

Okay. Yes, sure.

So outpatient produces the to rate I us right? cash for run revenue we and we've mentioned. That assumptions and I we're flow both mean, look, as side, comfortable that and gets demand a profitability, internally with on have made a certain breakeven inpatient forecast uptake that forecast

But So We've where are to revenue I on don't time not to be. our think what more granularity operating you the think we're we're at to do going I that said, math. this guidance. guidance as give I going given expenses provide can than rate run going certainly,

needs back really milestone. somewhat hit can to in to revenue where you that So into order be

provide Erin, a... want So you to

Erin Mistry

of then and around inorganically, is happens P&T the within process the then and process little by from The and product provide physician hospitals where product, Sure. I seen of in right? the through some the the meeting adopt also they We've advocates can it right, formulary internally, color a have usually, that us. systems. reach-outs organically goes both process. hospital of a product bit it the champion and the for the itself driven lot you to health and reach we've interest implementing out done had we've a So

ones here think the on a these health that to hospitals patients, have opportunity expenses. secured is payment we and to long-term NTAP patients side, mechanism those the approved, the leverage benefit inpatient those the have economics, I have the to the being of complications prior leverage we opportunity see that the we right, the that are also and

had from we've the organic lot a inorganic of hospitals. So and interest

Joseph Todisco

your answer Sir, that question? Thanks, Erin. does

Serge Belanger

Yes.

Operator

questions over will for Ferry I the to back from Dan call the audience. turn written now

Daniel Ferry

audience questions Thank have here. the from a you, written in operator. few Joe, we

first is WAC estimated was NTAP one approved vial. of per based $X,XXX on your The an price

vial. further, lower positive inpatient this impact explain will launched actual you about on on explain or WAC you you NTAP Do color with price provide decided? point have product can what the of you what to And you a around However, impact was -- utilization? can an what the this $XXX negative have reimbursement? expect this have Can per WAC the why

Joseph Todisco

side was going around the we TDAPA our Okay. outpatient price market different, taking necessarily utilization. Thanks landscape need landscape And market. $X,XXX ago, Since alone back size We've the priced X when market outpatient shifted. And on years. obviously, last thought years. specifically research inpatient with the the Dan. number X price. right? had the did for product sufficient the TDAPA the reimbursement visibility There's to established customers So TDAPA. to the in confident would the points, on settled application around on when both that a all, is market of inpatient And the with file right? much and uptake. a years We a first looked around and we analysis $X,XXX there. with the gotten ultimately, the ability process we of we conversations settings has lot side, X get didn't to now have time, outpatient comfortable to the of I'm very where unpack step second, of more X to, secure care specifically NTAP the start have over years. And be on and side,

that So really $XXX.XX is but for we a the established was price of reasonable TDAPA of WAC driven segment outpatient dynamics the inpatient. for the price by point

over the So acquisition the of to we and we took NTAP other the of was be years from NTAP a perceive of from they preferred inpatient pieces NTAP value lower as reimbursement. around institutions institutions to the the higher one that product of many cost X feedback last messaged key

the is we've favorable. feedback is that to side the WAC inpatient that on more gotten extent, lower the So price

you cost think on price of question acquisition side. about, that product negative utilization So to the point getting drive positive inpatient on expect feedback do impact the to The asked is utilization. I this have a lower or higher should the you we're

happy we're certainly, So with that.

Daniel Ferry

Joe. Okay. Thanks, Great.

presence? a here expected the conferences be is, are of there question can studies over And presented have months? coming you investors CorMedix give data which a any may or sense Second to

Joseph Todisco

over got a there industry going moment, to But but with XXXX in in Liz a a turn active you don't organizations why being and Liz, of we've planned ambitious number pretty Yes, field conferences. out ahead? thanks. to I'm that both go

Elizabeth Masson-Hurlburt

be of the Healthcare both We're Annual And field Epidemiology Meeting. actually. presenting upcoming or commercial, medical continuing both this stakeholders. going abstracts this Society year to are going and with Yes, Sure. teams, to and America spring over excited Thanks, to at Joe. be present key SHEA's we're dozen at a conferences for X connect

the Spring MAD-ID, SHEA, Physicians Conference, NKF include those Renal Association. So

I So really presence have there. we good out think a

Daniel Ferry

Okay. understanding a final CorMedix near Great. the term? of you can question give investors here is Joe, may missing? to over sense be that. Thanks is What for key what

Joseph Todisco

Okay. Thanks, Dan.

lot you're look, it in a assume about segment So think I understood, We're with about we're vernacular an atypical a TDAPA I therapeutic biotech acronyms NTAP, we widely of thinking investors. that's talk common going reimbursement through launch. trading stock a biotech that from standpoint. its very price are not a not also young a niche completely for necessarily We're first story still right?

think for launch also there's We on potentially captured of waiting a value launch. DefenCath value. historically, the we the long-term that that think a that have offering. But equity discussed of certainly in as I we're think And sat value on lot focused trading is of we've to investors new the sidelines there's stock. of So today, kind perhaps lot a not

more next on utilization expecting We established expectation years for have to real-world one, evidence, mid-year around can care. more over I of the DefenCath. the think data impact be that with meet And patients. broader reimbursement continuum that on we also but infection have look to we'd years, across obviously FDA rates the of exclusivity. certainly, that DefenCath demonstrating developing utilize long-term We're and as importantly, expansion XX.X to label our is But couple real-world of a

Daniel Ferry

the Thanks, portion concludes session. Okay. the Joe. written of Great. Q&A that Operator,

close the You call. may now

Operator

a you gentlemen, please your and that We conference concludes this Ladies day. ask Have for you participating you. and for lovely lines. Thank thank your disconnect call today.

CorMedix (CRMD) 12 Mar 242023 Q4 Earnings call transcript