CRMD - Earnings call 2 2023

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Operator

Greetings, and welcome to CorMedix, Inc.

Second Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry from LifeSci Advisors. Thank you, Mr. begin. may you Ferry,

Daniel Ferry

by welcome General Leading CorMedix Commercial Mistry, Joe the of Clinical Phoebe Affairs; is Executive and President Medical Executive Earnings CFO; and Liz and Todisco, Quarter and Hulbert, Conference EVP Officer. Officer Dr. joined he And Call. call EVP CorMedix. Erin Matt to morning, Chief David, Second Vice and the Mounts, XXXX Chief Dr. Counsel; Good and today of is EVP

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

future candidates, company's reimbursement potentially regulatory timing, expectations; company's manufacturing development licensing, transactions; through sufficiency business commercial to candidates; or possible and protections More product timing the the estimates to market and and breakeven specifically, thereof; the product projections as for profitability, costs. product nature the decisions, as forward-looking resources and position; current statements raising development property our as our product including plans about expectations of cost, and cash any to for and progress, other component anticipated cash of to intellectual expectations the actions, results, regarding our to include plans any company statements and interpretations projections projections clinical the bring spending and capital

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

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

Joseph Todisco

call. everyone, morning, you and joining Good this Dan. on us Thanks, for thank

following affairs the meeting November our of will update that review date Phoebe milestone target has the Over provide resubmitted and subsequently Most for to announced NDA months, number to XXXX. on a today date. a was action for with XX, action regulatory brief leading accepted activities up the the a of had announcement A X importantly, a key last company DefenCath the Type achievements. FDA been

of $XX,XXX up hospital to Medicare and issued addition to we CMS, Services, Center an proposed for reimbursement NTAP that XXXX the or payment inpatient prospective announced for of that per rule included resubmission, Medicaid In stay the DefenCath. its system

DefenCath announced also composition Patent of solution had company providing The the claims NDA the preventing reimbursement and for of rule hospital a Trademark this upon the for prior patent of catheter up XXXX. for that X, in conditioned catheters. central stay and directed approval issued We this DefenCath are allowance infection to CMS July Office the happy of in published blood to final per flow approval to final now announce week, venous lock notice U.S. of the to past NTAP regard, reduce $XX,XXX obtaining that FDA its

has the of and application will DefenCath, intellectual issuance. allowed available paid proprietary has to an the XXXX, date anticipated patent is This now property CorMedix in upon our the moved expiration the FDA newly marketing an approval nature fee issue exclusivity current to XX.X of U.S. and years reflects which protection NDA. application beyond and DefenCath the unique of extend

X X of months XX.X of plus QIDP exclusivity exclusivity post-approval of study. pediatric exclusivity entity X years chemical marketing years a years of for additional As the new a but anticipates reminder, exclusivity, conducting

period, year gross from were public approximately proceeds and its offering FDA fees of approving company XX.X $XX its before total that which as references any More barred underwritten recently, be expenses pricing ANDA exclusivity that the stock the During the in drug. comparator would of million. announced warrants, the and prefunded DefenCath an common

additional and In to addition, announce million the of the approximately expenses. fully overallotment that shares we underwriters proceeds X.X roughly exercised gross yielding of million $X today option pleased are before fees

obtain relationships broadened date approval assumptions. base base as This Street. internal in investors of well quarter NDA XXXX, other launch of equivalents, profitability, also financing Wall successful to on resources and anticipated with will first able offering, through short-term us action financing DefenCath are considerable the our target investments medium- added institutional we The to commence a this our the assuming to from across provides DefenCath long-term with to case existing shareholder together achieve The proceeds as and of fund launch our timely CorMedix cash, enable the and of new financial commercial the to completion resources. cash available our

over towards I to turn for the and update discuss to Phoebe call will a potential brief Phoebe? now regulatory FDA approval. progress

Phoebe Mounts

everyone. morning, Good Joe. Thanks,

application mentioned, Joe and review XXXX. the granted the following of target of accepted the NDA, DefenCath date FDA XX, resubmission action As November a the for

and the NDA consistent process review for communications received as we well various pre-approval inspections Over as information of for the vendors standard FDA. product from notifications scheduled to application related by have agency requests the normal past with from being the few our months,

as of cGMP FDA the teams regulatory well deep the we process, approvability consultants technical team, preapproval as of months, anticipate multiple FDA manufacturing an product. an primary with contract working in for the and CMO review of site external of with operations, goal primary quality our to experience coming critical part pre-approval communication upcoming the As towards be are which CorMedix's in the regular inspection. will organization preparedness inspection

site heavily actions team of CMO any are FDA of corrective focused Ahead on working API, to for with inspection. the and the the of readiness the past we effectiveness verifying confirm

share appropriate. will company the regulatory additional forward, when updates Going

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

Matt David

today compared contained of Thanks, higher XX, an $X.X million net million with you quarter increased read per discussion ended driven increase net an the share loss update cash prior second the expenses results. With to I more am XXXX. Operating XXXX. share and information our compared the XX% of June The to in quarter loss included an $X.X Phoebe, $XX.X company our $X.XX to increase R&D a our to SG&A with financial as on XXXX XXXX and second by was expenses to second quarterly complete the million and report in to in primarily in urge of in the and quarter Form has per affairs increase second million, position. be XX-Q R&D results approximately The recognized provide XXXX. report in pleased results, a $XX.X costs of I half XXXX. an good approximately approval, XXXX related second loss versus for to approximately quarter in here by or financial respect overview its $X.XX quarter of or personnel compared marketing million to expenses in filed XXXX the increase with on manufacturing CorMedix's well an the of to quarter second its in an medical of activities. XXXX first the expenses morning, of of everyone. quarter expense costs as XX% $X.X financial potential related increased for DefenCath our

increased XXXX. expense second quarter the an to $X.X primarily in to related attributable SG&A in XX% of XXXX approximately of was costs second million $X increase the in million to This increase quarter in with due to market expenses for in the and a additional offset marketing preparation research potential period. prelaunch activities decrease the approval personnel hires, fees by an increase for studies partially legal and of DefenCath compared in

first its With of half to our in in to to half of total increase increased $X.X expenses potential financial half million an with personnel million, to R&D the to first expense an million, activities. the and the $XX.X manufacturing primarily in approval for affairs an to amounted DefenCath compared XX%. 'XX of increase increase costs by of of $XX.X results, prior respect XXXX, in operating XX% an XXXX costs related marketing related medical increase driven first expenses,

SG&A million an increased activities prelaunch to of preparation approximately related fees the driven in the an a partially in in marketing compensation. offset expense These first for XX% were noncash by half studies increase and potential with increase increase primarily personnel by increases expenses market compared to in legal approval XXXX, period. research $XX.X DefenCath, an in costs charges decrease of stock-based and the for for

in of of primarily expenses with We to XXXX operations half first compared million loss net same during recorded in in the as first increase compared attributable used an the half is in cash $XX.X of period by XXXX. driven to The in primarily increase an operations in the used million $XX net of cash net increase XXXX. operating

CorMedix $X.X CorMedix With perspective. equivalents balance XX, the quarter pro approximately of equity has approximately strong including our offering, XXXX. million the position closed that $XX The approximately includes and cash XX, company equivalents million our June million. of of during proceeds $XX.X forma $XX.X through program, a net raised our cash a during ATM and cash million June as This second recent has is in equity in July. from of of closing financing announced XXXX from sheet XXXX,

well of investments flexibility resources anticipated we are commercial profitability, obtain to gives cash, base the commence timely our We fund assuming approval short-term through of case cash quarter and target assumptions. and to believe to available able internal commercial potential DefenCath the other as first company the action a equivalents, XXXX, our launch DefenCath achieve as date on of in the launch NDA

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

Joseph Todisco

a to Thanks, Matt. quarter the we CorMedix, expect a continue for busy next few over months. been it's pace Certainly,

regulatory preapproval medical working CorMedix prepare upcoming effort key diligently is our stakeholders settings care systems to health are in engaging potential are our Medical partnership with across to CMO of strategic the we for for teams months. ensure our and While help launch to an positioned similar inspection, commercial teams our quarter, last arrangements technical and in an announce with We early a other hope with to of DefenCath and happy in XXXX. well Boston were Center upcoming announce affairs

We we are reimbursement last reimbursement. with secured discussion CMS published and have an around for conditional also via preparing are pleased the expected inpatient outpatient in to CMS XXXX late NTAP by week,

we It have DefenCath dialysis not renal by As on a the as not classified captured which infection believe discussed an do categories existing currently preventative, should ESRD is calls, that inside any we prior be functional service. is bundle.

payment expanding drug Though innovative unique an ESRD, TDAPA that Part as we Congress CMS bundle is do health reimbursement TDAPA B remain to We innovation as in to as of an make pleased outpatient proposed preventative, that from add-on structure CMS should reimbursed recently therapies adequate believe to we feel be years we or infection TDAPA improving our years created drug strongly always intend X product were incentivize outcomes. ESRD. an J-code. adequate to treating X treat product essential to that and that the see reimbursement framework a the is outside case should to products with our for transitional

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

our position. and at in expect do providing look ahead target on in I in to dialogue shareholders this forward we CMS of date as point However, that is operational to documentation engage time, the action supporting with a our execution agency with approach CorMedix November. submission, we updating reimbursement focused squarely

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

Operator

floor the open I Should for questions?

Joseph Todisco

Yes, please.

Operator

first The Butler Jason Instructions] [Operator comes from with JMP the question of line Securities.

Jason Butler

approval? that if any as whether vendors the those inspections. have the Is API then all update on And on of multiple institutions, status you or final do And you primary scheduled inspections us of your with now provider? and there can you post work that been approval. pre-approval reimbursement the mentioned were give any informed have any Congrats progress. Phoebe to in are discussions there already priorities occurred? color there's NTAP that secondly, what Can just preparation pre-approval the have any of

Joseph Todisco

Jason. Thanks, right. All

So question on the hold second. that NTAP, we'll

primary API with start your the around vendor. question Let's

As vendor. update the that compliance we on of of don't status any today, have API

what that, vendor That's date. from for as call learn we as remain otherwise think status earnings we the on warning with you A we until have compliance place approach feedback we Type last do should Phoebe, would ability have of date, The the the I our the them of facility. intend the the we on letter time comment to the agency the discussion what at of action said the the remains the want PAIs any other on case. in our a vendors? to meeting was to withdraw action

Phoebe Mounts

sure. Yes, Thanks Jason. the for questions,

FDA are labs submit part you is working timing of by for and the there to inspections. the That the know, of are CorMedix. the through schedule FDA inspected of NDA, contacting those entities process. pre-approval that you testing manufacturers, As a not as are number contract does go suppliers, API listed through all when

So of the the in not we're timing. involved coordination

We without are for any aware has issues that went inspected been testing and DefenCath. well the lab inspection

So various as the But of vendors with. do hope we're that that's directly from as not something involved get occur. said, inspections I all we updates to the

Joseph Todisco

Thanks, Phoebe.

NTAP side, So on the reimbursement. Jason, inpatient specific that's to

launch. As up lot and both pre-commercial on them, approval, a a expect would put ahead a the mentioned stronger of for to us call we in we've looking to ramp in ongoing, activities, the got side on as side, commercial medical position the of we script,

health work On each of its with the a system in each system. side, doing own stronger right? we're a now So to has P&T put lot us process, health inpatient position

Hurlburt for bit we inpatient specific little affairs her Liz right, on line. is on comment going to ask prepare what's a on, the to to about the going side, I'm commercialization. medical as

Elizabeth Masson-Hurlburt

also we with numerous and when the nephrology, we learning for care, infection Joe. field interactions and to hospitals they had current protocols systems or medical past the patient we've us for decision-makers that current comes with place have is In what are therapeutics the in stakeholders learn commercial has clinical based valuable these team, community engaged along practices. P&T the firsthand clinical these quarter, clinical prevention. several have the disease, Thanks, best and provided the their . And educate to team really in and meetings. infectious pharmacy in has can remains to And meetings patients. on outcomes, need catheter And mock and opportunity safety health underscored and so diligently what it unmet

Operator

the line Next Joon Lee from Truist question with comes of Securities.

Joon Lee

onboard to look we about the in the thinking that. And launch, going have initial you reps follow-up. to many be are As How of sales SG&A? ramp I approval and and a you cadence the how should

Joseph Todisco

bit question, while asking that You broke up little you a but were [indiscernible].

Joon Lee

This Joon. is

So...

Joseph Todisco

sorry, cadence asked and Joon, I ramp Oh, you. what couldn't reps? Is that you heard? the I of SG&A But for hear about the hiring

Joon Lee

Exactly.

Joseph Todisco

Okay.

changed point quarter roles of ramp team, since over talked. over on the We've to medical from thinking months really We're affairs in on grown hasn't at we should today. But dollar our employees the in team. side. you this the last much XX-some-odd management built way think give XX, hiring the last not guidance level leadership going we to be adding about employees couple We're it, thinking XX our specific medical functions. about we've this commercial at right our We're I key So now time. field -- last out year the

offer and toward approval, and team personnel range a talked on assumption get that, an field in I the have quarter launch about first And We've XXXX, of it kind and to actually would to letters personnel, in the them do expect approval date. after action with assuming we the work shortly in holds. until identify key onboard approval around that field-based to have XX. be of onboarding the inpatient think then still the candidates goal wouldn't we and of When those comes we hand, an

we leaner it's the side, outpatient a On team. think

that a You've business. consolidated more base much got the side customer on of

on at think, the a decision the outpatient XX can to robust lag roll really I side before We more little about outpatient are side. a going the we publicly vague time XX enough wait to outpatient launch around on And we've, right? is reimbursement that on to that out outpatient talked bit, we So launch.

around as So hand or on approval timing get we get approval hand, a able in specific more if costs. we'll guidance be we provide bit little to and

Joon Lee

with how initiative I be Medical. you a disclosing question more elaborate Can study? follow-up strategic sort so results a That's and your really had, you just study little of of interesting. real-world that? bit will The Boston that on It's

Joseph Todisco

Joon. about partnership. ask Erin to the to sure. Boston bit like Yes, little I'd talk Thanks, a Medical

Erin Mistry

Joe. Thanks, Sure.

on and and that is future related just partnerships do results So and looked then current initiative of then BMC, evaluate any a we we'll collaboration to to post compare to real-world data them this . II at with the second catheter-related for and data publishing approval. the patients to on that we infections, have. plan The approval we DefenCath utilization to additional Phase the retrospective implement in focused prior hemodialysis the what

We provided get learn from perspective. dialysis that how more. for is the very there. about a learn important are institution. in [indiscernible] organizations this commercial by patient So is the organizations One, other We us we population bit a into like

need will the So that support and is product data drive further that have important and we very the we to results. actually

Joon Lee

final the strictly place space. -- to related getting Congrats for [indiscernible] dialysis? there's $XX,XXX-some-odd to my that's to that To on question. Or limited any in per space reimbursement for it. restricted hospital hospital Got NTAP And that? confirm, other

Joseph Todisco

want specific little to do bit more? a utilization on to is you reimbursement elaborate NTAP So the Erin, label.

Erin Mistry

Yes.

per it is Just to label. Joe, that point,

side. the And patients restricted recognized not just with So to an inpatient that side. NTAP. But the inpatient yes, it's to the -- on it's agency, CMS, CDCs they've hemodialysis get easy on

met we've so that criteria. And

benefit outpatient payment look so to as separate on And we're we well. as our that utilizing for the

have So companies the little conversations into that's it's these institutions very standpoint. But with approval -- procurement then very a the go that your you a robust we Most earlier, the strategic have to better. unique until from and where helpful and a they on price wait understand NTAP bit financial at reimbursement already both have right, have sides to ability secured, point from perspective. and ability a

make that So to and we able more are process earlier. efficient

Joon Lee

follow-up hospital how stay cap there you will on reimburse if they eligible any that Is for? the on stays? much $XX,XXX a meet like that. all they for related hospital from do a Just will reimburse Or criteria, dialysis

Joseph Todisco

Erin, ahead. go

Erin Mistry

Yes.

NTAP works -- over the the DRG. it's and above So

DRG and once So over just amount. NTAP stay, above maximized so the and it's take DRG, an for say, is that inpatient let's -- $XX,XXX a is

And year. can get amount in up for they stay but is maybe there's hospital their hospital the the And a it, that If times -- hospital for every maxed to each goes maximum so per this do amount can stay. several they that they how in different on has and DRG receive out that patient $XX,XXX. calculations

Operator

the comes & of Next from Rohit line question Bhasin with Needham Company.

Rohit Bhasin

Can CRBSIs, DefenCath? proxy then trajectory do that for of question, a could is current potential to launches And launch Rohit part guidelines treatment there second on to for drug and provide reduce a a This you expect what hospitals at recent them? talk DefenCath about similar Serge. are the any of you are be

Joseph Todisco

Rohit. Thanks,

Liz going of question have of to comment. current terms guidelines, to on I'm the In treatment first kind

Elizabeth Masson-Hurlburt

Sure. Joe. Thanks,

institutional needs at organizations. regular are vary. hand reactive different times. skin of there learned a care way certain is that on lines patients. but to institutions be they a we've their is is of there coming and a addition other types based the [indiscernible], They are are their SHEA cases, with gloved, all national providers to performing and a different catheter than are most number and an there's are then own up there the care proactive utilized safe, that keep number But cleaning not the of of the clear catheters X antiseptic things and different of that this guideline national what from can to may in on variety consistent in unapproved preventive hygiene So an precautions with that not And gaps to ensuring are of on and now protocols CDC or are more guidelines of right And and available they cross Currently, that in health tend best contamination, be is how unfortunately, a are there population. reduce taken the doing. of of infections variety the locks take

Joseph Todisco

think we're good right? truly prevent that's of is to terms find And infections. in either something is the that a a We're what the drug thing, actually in is real a your And on our And think that's first-in-class to launches, product not outpatient product similar question therapy. We're to knowledge, launched play to out It launch So this we preventative, treating comparable. I inpatient right? infection. a similar struggle Right. in we looking pure here looking a no space. or has space

we certainly that So thing. a think good that's

of think no prevention right? lot side, meaningful NTAP population. right population, X, our now, currently that a there the for meaningful FDA-approved it and X there's be approved, the on against antibiotics perhaps for why inpatient So cephalosporins products including wasn't we're that the are of as products same for next-generation some competing where in We got any drug the different will therapy, hemodialysis CRBSIs reasons

So we're looking at this therapy. a truly first-in-class as

Operator

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

Daniel Ferry

Thank of here you, questions a have audience. operator. Joe, we the couple from

first is, the TDAPA changes elaborate on the you extending in program. X recent can The regarding

Joseph Todisco

said, products innovative want going reimbursement. of a think to separate them is that, TDAPA, focus years. And is to They've X Sure. ESRD a in innovation to else right? That treat to TDAPA happy CMS our obviously, there that space, you'd see I'm think was It extend lot is adequate reimbursement reiterate do that, addressing reimbursement. recognizes lack we Erin, of for longer an on additional right? we working want I on is So were comment right, begin that added with ESRD, that that changes? the And reimbursing beyond while necessary of the to anything X add that years for

Erin Mistry

think providers covered has a thing that good helps new to TDAPA, create just go incentive think look and the utilize additional if payment us, to I for that mean, working it. therapies, agency better around recognized them the X the So you forward innovation I on with I years route. for right? post we the specifics, we

Daniel Ferry

right. Thank Erin. you, company Excellent. around this especially to disclosure another Joe. Joe, Thank on financing, you, the All of X financing the future take the breakeven recent here. light having Can comment strategy, you profitability. possibility to in

Joseph Todisco

Thanks, to Dan. financing? comment Matt, do you on want

Matt David

Joe. in we on Sure. our the past, Board we future conditions for up proceed. plan will launch commercial say Thanks, comment and ramp position offering the as strategies needs, financial recent financing. equity various we our company as management market Sure. and really toward evaluates plans that CorMedix's regularly completed to can't and I of we for potential the the DefenCath. a Yes, really strong as put in

Daniel Ferry

Matt. Thanks, this Operator, Thanks, concludes Excellent. question-and-answer session. the Joe.

You close call. may the now

Operator

concludes This Thank teleconference. you. today's

your Thank may participation. time. at for this You lines your disconnect you

CorMedix (CRMD) 8 Aug 232023 Q2 Earnings call transcript