Earnings call transcript Q1 2023

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Operator

Good afternoon, and welcome to the CorMedix First Quarter 2023 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. is event this note, being recorded. Please

now [Vanita Kossi] would like to to over conference the (ph). turn I Please ahead. go

Unidentified Company Representative

and Chief XXXX Good Executive Chief you. and and CorMedix the Mistry, Phoebe afternoon, and today earnings Matt quarter call welcome Leading Erin conference by EVP Joe Officer. EVP Officer is of Dr. and Thank David, CFO; is General call. Executive joined and to President Commercial everyone, he Counsel first Todisco, the Dr. CorMedix; Mounts, Vice

we I would like known but any include Before the risks XXXX. the the remind call statements limited of not of statements are the are following. Act in meaning These forward-looking certain to and what Private are during uncertainties begin, Reform to to everyone Securities set forth and management that may as Litigation within make subject

fact NDA than and activities clinical and other and of future plans statements product DefenCath or revenues DefenCath potential acceptance or candidates, future company's projected other of statements development prospects, about product goals, financial other market Any management's its position, approval the in including candidates. historical and expectations, U.S. costs beliefs, manufacturing for program, regarding

transactions, anticipated any nature manufacturing and and projections of the costs. estimates product to actions, to or candidates, regulatory about and commercial include our cost, statements specifically, cash expectations capital and plans and development position, company's More possible and results, business expectations, other as to raising forward-looking our future clinical progress, interpretations plans, timing expectations the thereof, any the as product licensing, for product statements timing, projections development and component spending market

at are uncertainties estimates limited in the latest available filing from a greater XX-K, in materially SEC's to factors, of from Form request XX-Q charge on to These approvals, or development, www.sec.gov detail which differ free copies may regulatory annual are to of including clinical including risks variety at the commercialization. due SEC, Form and but results projections described important these report or upon CorMedix's not report of related with CorMedix. quarterly the and on website Actual

may statements. not in these CorMedix these statements, that should plans actually forward-looking CorMedix Please on not or by statements, to investors undue note except goals place update reliance these law. does these not and required intend as forward-looking described achieve

my Todisco, At of Joe Chief this is CorMedix. turn time, please ahead. to it go to call now Executive the Officer over Joe, pleasure

Joe Todisco

you, [Vanita] for Thank Good on joining (ph). this you thank everyone, call. afternoon, and us

milestones. in this importantly, resubmitted proud last FDA. the NDA Most our for company the has so the important company worked number March, DefenCath objective. would that earnings achieve today's is ensure announcement hard has team of that I'm Since call achieved being the to incredibly key a the to

April. a a with to be as in will month Phoebe, six A substance of And anticipate with around color few target a more provide November. meeting we our in classified ago, expect Class action review as do FDA we weeks announced and Type the date the resubmission X

status confirmation We will the from once regarding FDA the update NDA. submission investors have we of

announced two that important for also drivers key value resubmission, can addition In DefenCath. business we to our updates be

Medicaid includes following the System Centers duplicate Payment XXXX Payment, an a hospital of anticipated WAC increase Prospective previously the stay. vials stay the meaningful milliliter of XXXX price of represents hospital $XX,XXX is per for NTAP quarter in facilities Inpatient our with X an at approved XX% rule per first, The This of of Medicare NTAP, to or to inpatient submission vial, DefenCath. New XX.X utilization above application, the to NTAP Technology $X,XXX with for a reimbursement up Add-On the per fourth & average proposed issued CMS that of the has Services,

in a to migrating final mentioned to update, preferences. The that X recent X milliliter mind. upon late obtaining to NTAP This in As NTAP FDA expect amount the be based we conditioned our be issued with July was will will CorMedix DefenCath rule summer, application this is migration IPPS from volume prior and final in submitted in published vial upon X, approval final that NDA we payment milliliter DefenCath to XXXX. rule. market This be a

blood current The lock also to U.S. allowance Patent a issued catheters. office U.S. central of the preventing This solution a anticipated the recently the unique company half an reflects protection XXXX, claims notice an of newly approval DefenCath flow of for upon intellectual exclusivity in that FDA the directed nature which date Trademark Application proprietary announced to Patent venous and and is catheter marketing and NDA. years composition our expiration of patent property extend infection beyond a the and will DefenCath, has & reduced of allowed available in of ten

Book, related includes in which products to Once the drug as identifies listing approved Equivalence as is products seek this Therapeutic and patent publication approval exclusivity patent information, we part FDA's of Evaluations, known granted, plan NDA approved Orange with the and process. drug

diligently While DefenCath. and preparing have resubmission commercialization, affairs our maximize teams medical regulatory for been the our teams have is CorMedix in to been the with care engaging value supply-chain ensure settings technical stakeholders potential toward and across to working key and of of commercial our

multiple of we launch formulary the committees of networks delivery members the process. focus begun pharmacy As prepare technology hospitals systems, with our phase leadership on have for will and utilization, at health to and inpatient integrated better engaging initial

be baseline system health at to establish quantified. institutions in institutions expect of the that respective rates to during their We upcoming months with such the impact work utilization the infection can DefenCath

we've On adequate prevention related also complications infections essential reimbursement the severe CMS to reimbursement. venous outpatient the remain infection improving one of as receiving with with catheter, central through side, providers most to discussions stakeholders hemodialysis outcomes. for Catheter-related to and intensified we and prepare is bloodstream customers for associated patient a potential engagements dialysis with outpatient

approval. receives A formal NDA be application for submitted FDA an outpatient until reimbursement cannot after

expect months. begin upcoming the position providing agency our do a CMS the reimbursement with documentation dialogue over we supporting to However, with

turn approval. to now to over Phoebe and lines A Type the meeting will FDA, call with Phoebe? discuss our for potential time I FDA

Phoebe Mounts

afternoon, everyone. Good Thanks, Joe.

gratitude to to by start soon to technical to expressing that my regulatory team like would worked as and as prepare NDA I possible. First, DefenCath resubmit diligently the have the

you August and solely have which earnings letter or to last developing of complete XXXX. know, response at calls. DefenCath As received Since and technical as different suppliers two deficiencies in ingredient manufacturers we pathways, products alternative during API our NDA finished teams utilizing resubmission Do the CorMedix ensure CMO as deficiencies. August, possible, pharmaceutical and quickly been discussed regulatory cited have three to citing a active no contract clinical related of but

a a in we request plans FDA April. were meeting gratified, provided justification very supplier March, for resubmission related A FDA granted positive a documentation API to Class Pathway with and X existing and request a that would our to meeting review we resubmission, The existing submitted support significant X Type and FDA discussion In X utilize the and FDA with discuss to period. for productive. for XX-day with We've compelling NDA CMO that was Pathway to

valuable, API. heparin We Class resubmission now only the the sources served with this feedback, but would the multiple information resubmitting CMO, guidance. However, view NDA inclusion be based receipt of following necessitated highly meeting a is formal in API with better by minutes from FDA's in CorMedix result in period. to six-month it FDA multiple review expect discussion, apparent the agency X DefenCath a as of that discussion with of our incorporating The manufacturing with existing our of heparin not sources was NDA, the and CorMedix the we of resubmitting submission, accordance new which inclusion upon

that target November. it X with action deemed receive date in NDA believe will the a when PDUFA accepted for review resubmission is six-month We a and filing, a be Class

Joe and when will if provide additional CorMedix As milestones achieved. are these mentioned, updates

Matt? will would like financial over I to a who Matt, the turn call now provide update. to

Matt David

to Phoebe, to and CorMedix's here am today good first results, our I financial afternoon, Thanks, update position. as an pleased as overview cash on of an quarter everyone. well XXXX provide be

for filed read contained the a report The XX, you discussion Form on the information company XXXX. its in urge to more quarterly quarter results. financial ended our has report I March of XX-Q complete the for

net of and in million XXXX or $X.XX with results, the an million our to or first first loss XXXX $XX.X our approximately was respect per loss quarter XXXX. recognized a compared first $X.X in compared share of With of included net quarter share versus per loss the expenses $X.XX higher quarter XXXX R&D of financial with in SG&A The XXXX. expenses, increase

million and XXXX costs of driven $X.X R&D expenses approximately approximately in the $XX consulting primarily and for in increases non-cash with in increases in expenses first offset increased of charges marketing personnel to XXXX. quarter first manufacturing were its $X to related to million related increase DefenCath XX% the These to quarter medical fees period. by activities expense and million prior of compensation compared increased potential a by an costs to the for decrease by XX% in Operating approval. partially affairs, the stock-based

XXXX the the SG&A stock-based decreases This studies to an costs expense fees prelaunch million were in attributable due expenses offset potential additional by marketing compensation. DefenCath, XXXX. in quarter for to in increases market preparation in increase for with non-cash to These to million related of quarter period. the of primarily compared legal and increased activities in personnel charges increase first first approval XX% research in of and $X.X approximately an for the $X.X hires was increase partially an in increase

of quarter of through $X.X company for million CorMedix $XX.X approximately operations XXXX from equivalents approximately in proceeds $X.X net of program, million has during in first XXXX. quarter during $XX.X This of cash raised cash including remains cash the sheet ATM used with the a $X.X million perspective. and XX, million recorded March net We XXXX cash in first includes from ATM quarter good balance first as of operations program. position XXXX. our the our used a of net in million compared of The

CorMedix Following has equivalents end XXXX, of first cash March million. the and $XX.X quarter XX, XXXX, approximately of pro-forma

cash company half equivalents consideration, potential to manufacturing DefenCath. launch believe costs approval through and anticipation fund gives related preparation, into operations flexibility of of related After of at XXXX. to costs to in the its FDA We activities cash taking our the commercial least the first and

the remarks. closing turn to over I Joe, back for will call Joe? now

Joe Todisco

Matt. Thanks,

increase focus As believe mentioned commercial our company the I on readiness. will on and now is key I well objectives, executing earlier,

made heads affairs, last trade. and few commercial operations government a of in affairs, strategic and of most notably both market leadership key medical number we've the months, hires Over access, partnerships new

We resources will add progress during the as we continue to events milestone additional year. through

target and quarters, launch will we earlier, we provide beginning will in date plan anticipate middle of opportunities, market as As commercial the clarity early a more launch for the upcoming and action the we as of In said November timing. XXXX. expectations around

interest in an and Thank you support CorMedix. for your continued

Operator

[Operator from now session. will first Joon question from Truist Lee begin Securities. We will our ahead. question-and-answer be And Instructions]. go the Please

Unidentified Analyst

taking is evening. for [Les] (ph) Good This you on my Thank for questions. Joon.

be protocol ready would are what for add when you in with number the FDA two? First, the the CMO to

Joe Todisco

Les. Thanks,

of for supplement. a I as it think plan CMO our And that's presumably the would the current NDA submitting be plan. post additional approval current

Unidentified Analyst

a earlier? Thank you. it. about reasoning the Got now bit and change behind been rate why the more talk Can you not that fill has little vial proposed

Joe Todisco

market with submitted approval But in submission. multiple that agency in to original gotten the If heparin heparin, then sense Well, we square supplement. would add had opposed wanted would only additional Xml that doing we and a outpatient to a sources tap Xml smaller they inpatient preference research, out pursued we and would this API as the makes it given a the probably saw the the that as engaging it of twice. only, vial side, the fill as for we one-time include Xml began they have

Unidentified Analyst

Got it. helpful. That

about And Can expect. newly that to one for the any you then the would timeline perhaps more more patent potential of bit and the strategy deal a Just follow-up also handicap to filers. issued the that, little what exclusivity of strength me. with talk your be you'd end

Joe Todisco

that years if would it's already have to book going be generic claims I competition. that which this the do marketing material [company allowed are patent Book, meaningful. it, eligible the issued, means listed the XX.X mean, filers] to we exclusivity, think to certify can Okay. generic Thanks, listed. (ph) be We And newly right, Yes. against Les. post of right, think be is very Orange once of barrier in a the to it's Actually, expiration

around the these difficult qualitatively going of FDA. So of to very versions substitutable. FDA design view, solutions to of same that and to generic demonstrating in ingredient it's have be obtain patent designation also demonstrate generic for injectable order a quantitatively from an substitutability terms in the claims In to they're active the our as while

claims. the good So we about feel patent

question? you you were second In clarify -- Can the NDA process. the of that asking about terms question

Unidentified Analyst

Yes, defence any potential legal I missed that might with you deal come across. your NDA strategy strategy, your to filers

seen we've industry stage think happen I any that launch. of early recently at in

to anything. just I you see So wanted if have

Joe Todisco

can't really the stage. at happen It early

approved is that patent lot an have, that the regardless it even submit the have So submit. and taurolidine can I who's challenging let's Because things. means clarify five that of NCE even NCE of in be taurolidine of got can't mean someone challenging And DefenCath, generic the We've a XX.X a submit for patent exclusivity for our component filer on One we years. to couple a of XX.X years. a can't time related can and before we an that X years. application years quite NDA exclusivity do not patent,

now there's litigation say. So strategy, need comment on we think when do of and between a let's I time IP quite to lot

Unidentified Analyst

helpful. Got it. Very you. Thank

Joe Todisco

Les. Thanks,

Operator

[Operator Serge will Instructions]. go be from Needham Company. next Belanger question The from Please ahead. &

Serge Belanger

on afternoon. prior questions think approved. good recent XX% included the of Hi, most reimbursement, bump total a the approval guess for was NTAP couple that on first I the A I us.

drove does how significant inform So level price outpatient level that And just reimbursement bump? pricing curious that for the -- that segment? what your pretty kind for how's of

Joe Todisco

Thanks, Serge. Okay.

application, of of you're ml X So -- essentially NTAP the X X migrating new which a getting to for each the Xml terms vials, to meant in we millilitres that is liquid. from Xml, patient

increases. So the dispensed liquid of amount

in as to vials opposed a the were original in large the XX.X of the X.X that application. increase that's portion NTAP So

most drives change of that the the the So in NTAP.

was of your around question part second The pricing? outpatient

Serge Belanger

NTAP if Yes, reimbursement this --

Joe Todisco

We're to related, Okay. the -- right? on necessarily outpatient How I'd what yes, going working be. does is that it not say inpatient pricing still and they're strategy

what healthcare And I true necessarily we institution, price not NTAP, mean, net be which we've the going on institution. said to to it may to is outpatient have of materially to reimbursement be be the is an side, pricing net So is the but reflective the going lower.

as how different understand guide patient today different patient So much to going. size going we to we're there where to we that are and not therapeutic just see population. segments, But lower

is two to pricing going be the those to So have in settings. different

Serge Belanger

economic incorporate Do about expect Okay. ahead thinking the of part And the pilot a setting. the kind before year, inpatient or next studies implement facility do just practice? we each especially early of product they launch of in product should trajectory? think as How you will studies and the

Joe Todisco

right required the Look, conversations be I institutions think now of to we're with going of work through [PNT] process. having a to lot (ph) what's

system. with I (ph) the some think time for to the each of going launch, the take work [PNT] to initial through process it's phase

conversations Some to the be for are groundwork going others. to pursuing are now and going right launch. partnerships a Obviously, faster the lay better we're than

provide I any think, you Erin, do to want more color?

Erin Mistry

launch. is a the had Joe. -- parallel we part full well Thanks, and have One analytics obviously that point, as segmentation commercial will the as institution, process do right? champions others than do pilots, to Right? are to now can for who that value, this ease through. will what's help will who right of getting formulary. the understand take relationships. physician rubbing shepherd The on -- who And frankly, the that to are that's we're lift discussions dependent partnership It's of heavier and we're that strategic in where face Sure. Yes, running on want

So to it's institution question answer dependent. your

Serge Belanger

you. Thank Okay.

Joe Todisco

Serge. Thanks,

Operator

at the and over (ph) [Vanita talk questions to additional gentlemen, ladies our And audience. this for I'd from Kossi] like back to call turn time,

Unidentified Company Representative

did We'll read now and go will some questions written get operator. in questions those we you, questions Thank here. I --

parts X? be why there's And think will other any Okay. you to FDA outcome When changed? pending? question, this What's inspect to you the it. CMO CMO would a NDAs first time? does do your expect And couple different the Okay the have

Joe Todisco

Thanks, [Vanita]. That's a question. good

deep those might what of time, increase engagement different consultants the months, terms seen external CMO in consultants the think we've and significant last with have I be in this experience. of FDA eight

potential by So optimistic we've out action now. the and reinspection corrective corrective those PAI implementation actions original what came ready terms we're in inspection for we're of encouraged they're that and seen of

post own best once PAI provide and said, that have So any we do do could date, any implementing address site them we also all think so use efforts do to a observations inspection don't optimistic I we is arise. help And our we're inspection prep with seen final I of what for support. CMO, can from can the new terms But corrective actions. we've the in

we've do. get potentially before filings, of that told have Europe in from they could PAI that other other terms sites we NDA a In NDAs been Western pending different

with be them anything could facilities to FDA close going impact understand at observations in that certainly to other application. contact or we're our So any

Unidentified Company Representative

Alright. you. Thank Okay.

Another the target application. And heparin its from has what color more provide the FDA in happen if why wanted date? supplier your question warning will here heparin action the audience, on of you initial resolved sources before the letter two can of not

Joe Todisco

Thanks. Okay.

I existing I first did rectified concerns, of it's in think heparin had script. compliance with heparin, strongly hoping get But given original the more from that submission to submit heparin source evaluate FDA addressing also data a during straightforward. CMO that agency site's good But the question, X the but to our the compliance think encouraged our view think give new We them rectified meeting, to us API the had Phoebe concerns. that data supplier pretty time include compliance. the to source the Class part job the the of I the were and a

new source the date to that is that I approval. not with resolved if pursue only supplier we're needed the withdraw that's to think should what's we get free yet to heparin action our warning FDA letter, target go and and

Unidentified Company Representative

And field how you up based of field scenario of about medical there is you are question team audience, the a you, last personnel? ramp hire side? the Joe. approval the Thank of here and about And thinking the how NDA on ahead from timing Okay. where

Joe Todisco

commercial a I about little guess think bit Okay. medical we Yeah. differently.

So date fall milestone a that's let's that personnel more commercial the at mid-November. us summer risk. assume hire that to PDUFA the give and course early happen along to There's that be events get we in going could of confidence

inspection I CMO FDA our that at think could the do PAI any bolsters confidence. most that importantly our

managers, field in and -- adding functions. mentioned it when already the the we the time the positions have letters them key based potential with what script, account I a But across want is it of to to around personnel in And the do we're do. those key after. comes onboard to As we're call leader and certainly to hand immediately key offer ideally going try identified approval then what that's

On up full bit any ahead medical staffed the potential a it's We side, need approval. the team really different. have to of

launch. We medical science eight seek time the right on have have those now four are liaisons we'll MSLs of and board around probably to at

are commercial and preapproval roles physicians the have as with can can they professional state any product. marketing conversations awareness professional around these on to to of discuss not personnel what critical and they much So medical are permitted more do limited disease we're types medical where

pull to be Chief Regardless successful, formulary of channel the know, contract and capable you need sides then qualified people get we're business. through. going recruit appropriately both to to access, on

Unidentified Company Representative

that close conclude the here now to further And Okay. written there does Thank are here. you. no call. it questions the back I'll operator to turn over online that --

Operator

attending our question-and-answer At We your session today's concludes very this Take time, much may this call. today's care. And Absolutely. you thus you now Thank for disconnect presentation. concludes lines. and you. thank

CorMedix (CRMD) 15 May 232023 Q1 Earnings call transcript