CRMD - Earnings call transcript Q4 2018

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Operator

Greetings, and welcome to CorMedix Fourth Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now pleasure to introduce your host, Daniel Ferry, LifeSci Advisors. sir. ahead, go Please

Daniel Ferry

Bob welcome Leading CorMedix Khoso the of joined Executive And investor Vice Baluch, up Financial of and Q&A. the quarter Chief conference Officer. Officer by is call He Clinical call. call Masson, CorMedix. Chief to remarks, afternoon. fourth prepared Chew, Head After Paul the for XXXX President Chief Cook, Good today the Officer and we Liz of Medical CorMedix; Executive Operations; will open is,

anticipated www.sec.gov development as timing, actions, and costs, of Actual development potential statements risks and plans and are any regulatory possible Neutrolin clinical at the Company’s intend a these other interpretations and future of available required costs, by Officer statements update law. in of like market the More expectations estimates may detail actually our to to any would thereof, management Any plans than free or this certain future fact forward-looking the Act due I results management’s described SEC, the projected except but to may commercial of candidates, candidates, product prospects, CorMedix undue over costs. other risks should begin, the regarding differ remind or clinical revenues are our Neutrolin everyone future and following. plans as call, historical These charge reliance variety uncertainties we pleasure and my statements and turn financial and not manufacturing and clinical U.S. program and position, described ahead. its regulatory achieve uncertainties go results, Before timing Litigation forward-looking within or of in the to goals during in CorMedix. CorMedix. the specifically, expectations Mr. projections Executive to statements Company’s beliefs, other related are about business nature the filings please and in of and for projections acceptance approvals, Baluch, other from but these not request the limited are set and plans CorMedix may in known product any or from cash CorMedix investors product materially to goals, the are Please commercialization. including position, projections to, statements, Reform of the as that factors, include licensing is that statements. and on it expectations, which website to These component and transactions, Private spending not Securities candidates. does with forth what these expectations, include, development statements raising, as upon make subject capital statements, to Khoso, place greater product note time, at as to to and At not for development, Chief including, XXXX. the Khoso of forward-looking forward-looking about copies now to, call of market statements and not these SEC’s product limited meaning the important

Khoso Baluch

for focus Phase and this you for us trials X call the capital financial planned Board three, And currently including on to an undertaking in are most raises for Good with Today's CorMedix. update number balance particular split. to strategy call. position three thank value on everyone, Dan. reverse and report can our analysis Neutrolin, recent and you, last for Number joining FDA LOCK-IT-XXX order driving meeting will progress the areas provide the we work requested in sheet, clinical Thank the the update afternoon, FDA two, Company's on the an with the complete. from the critical we on Number appointment. one, the stock and

key couple into me a cover highlights. let we details, Before get of

January, during First, made announcements of study. month the two LOCK-IT-XXX we related to

the in went we were Phase approval drug for and database the stands LPAD be approve request patient investigational consideration regarding mean LPAD, XX Pathway pursuant by disease no To primary for approval standards discuss was of or clear, provides on We for FDA FDA Subsequently, development serious limited for This study on market. XX from had pathway based the the that lock pre-NDA announcement that dataset. agreed the became to while to of analysis blood shorter specifically this were endpoints to second study this analysis meeting data The January total or with for and a top-line of for the the request it the FDA of the meeting, followed and with regarding as the bringing subjects subjects about study we of and if First, until after full interim agreed data the XX X of pathway. What the this disease for enrolling including regulatory XXth, support this the rather patients options, single based study time Antibacterial that to Because January the Clinical forward lock Please full recently to meeting, that meeting fewer XX that trials. meeting At the CRBSI results the the on to patients end a suffering shutdown. intervening originally for an included for Adjudication approaches release. use Company's with for Company and treating effectiveness from and flexibility Neutrolin events, the time appropriate regulatory a solution infection, in despite February announced treatment we just of Drugs. with not FDA the delighted top-line the XXX Neutrolin. renal government the it a first the to and FDA shared the to catheter the this analysis continued only at XXX the clinical safety hemodialysis. stream We determined was catheter-related preliminary Committee. XXXX, of meeting by undergoing discussions that interim product The Population study development as Neutrolin August terminated prior a streamlined dataset the pleased unblinded to as meeting populations on note including begun the Antifungal that FDA could set is Limited the agrees outcome. FDA discussionary CorMedix submitted meeting is on CRBSI. under our Neutrolin the the stage we unblended support on regulatory for at team required full the cases very evidence the approval LOCK-IT-XXX a

the The results of dataset has During review is and the the dataset detailed focusing us. anyway FDA. to the the robust available are endpoints since the analyses diligently patency had the and as data the newly the the information analysis decision-making primary the on the FDA's which assessment regulatory secondary Neutrolin, for analyses supporting goal full effectiveness, provide will These FDA time the facilitate analysis primary to meeting, conduct The application. evidence to which full of available the to to results. endpoints with unblinding just ongoing, FDA we LOCK-IT-XXX requested well catheter FDA's we study the The once top-line because required analyses safety fully with for impact are from regarding could additional getting the it for will as for FDA NDA of it's important had removal. be provide it work the loss submission These and pathway of is also the shared become to timing for drug us the filing. new

we impact filing. for is it So, may at And important the significantly level. quality timeline NDA it not while it that it's work, highest our time-consuming do an

We effort. analyses and more in call, next the the will both ongoing to this on in submit Liz weeks. this expect Paul on the details to provide Later several FDA

some pleased that to Company say the Now, let stronger is the move for today finances. financial than me a in been time. to Company much has position it I'm

which the few completion raise the keep that CRO cover with you. without successful further of in $XX settlement cash, the steps two us currently million are coupled into anticipate taking the to concern auditors Bob XXXX the to operations their and With the we going been study, last will quarter paragraph. CorMedix financial XXXX. we over has on LOCK-IT-XXX have opinion required cash with issuing management, over will the a quarters going expense details finance Consequently, tight our our statements

we major brought delighted approximately companies, joining its Board XX XX have and CorMedix at and Alan based a including depth drug has critical development like Research divisions Dr. positions developing to member, address has achieving experience. career and to of is At in over he Alan Pharmaceuticals it point the as CorMedix led Most public executive and his director major prescription in Board. governance discovery was XX he He of recent regulatory recently, and at was and OTC R&D drugs. seasoned research pharma In CorMedix as Vice Alan, and highlight in been made. significantly many CorMedix. Stamford. is of both would executive third has similar evolution operating department. corporate private of of reimbursement, a and into development pharmaceutical build Dunton has appointment new and a and participated an approval is commercialization has size President breadth Dunton and and I'm with The Purdue, I devoted years drugs. to a Development regulatory that the development, Senior this and Purdue

a felt Incorporation. Dunton two on Alan During private many compensation is a completed. a each board Cytogel and development committee of the Chief giant assets, biotech company these audit Foundation, as on to Director two Board of President pharmaceutical Managing for of Pharma, He developing companies, and for as Prior Dr. another to chairs mission companies of then and biopharmaceutical and his Alan arm a was the developed companies. company of Executive and of currently the his Officer the He's sleep one public at years serves Purdue, member the the Technologies left Palatin R&D products disorder Research regulatory Janssen of member of J&J. Purdue of two he pain. also focused Oragenics Purdue, treat inflammation. for had of years two been He

where Paul Liz to share ongoing Now, who FDA. the more the and you with will let's as we are in here with discussions

let with start So, Paul. me first

Paul Chew

Thank Khoso. you,

as with expect was about more the you was guidance our during the a of our with meeting the good the pleased have we First, while CorMedix we analysis. of that have to possible start the meeting outcome FDA. of to begin tell by an the want them. to full NDA. FDA we're with filing dialogue It FDA I as continue Neutrolin’s timing discuss regulatory to receive pathway Company we had positive regulatory lock to This questions interim pathway the the previous as requested FDA I and specific of we the with the had the about in clearly We with a the meeting database the that analyzing as the was extraordinarily to and The this wanted provided results meeting revisit received dataset. it. for Neutrolin on with soon meeting discussion work to line

as DSMB’s the the reviewed As the of the with and it top-line of readout happens, the meeting the well top-line the they database coincided had the data. locking after dataset full receipt guidance of FDA as timing

we’re report light the available of of our us FDA's a enter then provides phase internal of information full The that Phase CorMedix agree based This substantial single evidence of the strengthened an X we'll end usually end NDA our information X the once you on Once discussion phase can the new effort with meeting expected to that able recently study the occurs and share meeting to of fact is just cetera. is to in element clinical our dataset start the the further review. from from data we has that next and safety into effectiveness. FDA, request the meeting. discussions, of the which for to Liz was this that to Phase clinical a meeting have LPAD meeting underway. should believe file completed. an submission, for LOCK-IT-XXX which After rolling file us a request this how by we phase, such and submission, requesting During will the the cover priority the as provide our pre-NDA in this et FDA become topics NDA, request our review of plan completed is we'll flavor example will trial,

the ongoing to our can of hope other with FDA to and in basis, obtain an are where this In so addition, we the clarify there are relating place clarifies guidance the take the I with individual from on that sections usually several ongoing that agency. discussions NDA. meetings we agency helps

provide Now, efforts current let Liz to me the FDA. you information preparing for in hand further the colors who'll to the the floor as Liz?

Liz Masson

Paul. you, Thank

a team Khoso their the sent that expect while further the meetings. to As on file during is making the interested you perform is Paul clinical available. to based decision. all clinical working reconsider ensure additional will analyses of previous subset an seeing The aspects would to two and is the NDA. a mentioned, to guidance be are information a plan one reviewed the and on study information information the FDA cross-functional a requires regulatory to This additional on information the requirement the that their request before recent pathway. team normally face in section face of extensive and material FDA, more FDA Since our it’s data requested requests of preparing FDA,

collectively. on for variety data a we primary to previously these have first, analyses and the data amount are the endpoint, at two looked different in basis, a The we While the data focused to look CRBSI broadening data significant analyses now of is compile to at effort of perform many points. we as cumulatively

adverse of specific name events subject, the few. pathogens catheters by a example, agent For to just identified and location

is the up one these could significant. is subjects, many large of adverse any the of trend. from have and all medical XX the this leading significant and phase all numerous There and if contributing Neutrolin's adverse we will the thread volume review have is have to support tables, of such to this Once we tie As requiring along are then carefully clinical strict subject using preparation any complexities very review, we the clinics performance. before, requires analyses quality see This coupled CRBSI reviewing to data there sensitivity with information a due controls discussed of events analysis we factors. alone events. hospitals to tables with is events to and number completed of Further, to statistically a the to

data firm of front not time spend would NDA As normally I filing. be significantly affect previously mentioned, the that to overall on I as we Khoso. it now on and the information prepared to helps this the would NDA where clarify pre-NDA the all end, may timeline until as we the part meeting, in when Therefore, have call be of more this we an filings. premature it we turn as analyzing will to the the for hope Please are timelines file process. remember would I speculate over back NDA.

Khoso Baluch

required information Clearly Paul. CorMedix prepare Thanks, to the FDA. the Liz and important work to we as for submit

finances. and quarter Bob? ask cover results let four overall CorMedix's me Bob financial Now, to

Bob Cook

$X.X for the $X.XX our net With $XX.X XXXX. report much amounted our urge was to XX, quarter in The or million SG&A XX, reductions Lower report with lower cash XXXX. $XX.X compared Form in approximately $XX.X the expenses accounted expense net increases $XX $X.X expense million during approximately with used more as million net operating income contained or million million XXXX, annual R&D the ended of previous XXXX loss loss modest $XX.X with $XX.X XXXX, the in to inventory, XXXX. expenses operations in results. with CRO operations our comparison. the million respect by fourth quarter was was we financial XX for year, per you the compared in our fourth the compared Khoso, and quarter by due XX-K the December decreased for the net in year result Cash to company expenses the results detail the of of recorded $XX.X in operating during moments. and $X.X year-ended a quarter I with loss $XX.X December million payable million with results our for XXXX XX.X%. last in settlement cash used XX, Operating for reflected the the in compared fourth third approximately a we for XXXX while in the XXXX $X.XX a loss of XXXX. few months declined per the with you, Thank accounts of in of year of year-over-year financial discussion prepaid share I primary share reduced recognized a was during operating receivables of in an occurred more of in XXXX. benefit settlement this used net coupled to the operations primarily reason expenses. income With $X.X December on information respect has loss discuss the will plus primarily in the year-ended of a of loss million read in million complete CRO for settlement quarter. reduction its and from CRO expense a for The financial accrued November in the filed of compared financial The derived decrease or from decrease the to year, just million.

in from of the settlement, expense We the development in of fourth compared expense in we benefit of due XXXX. have expense in research expense As compared U.S. XXXX, The operations marketing booked $X.X used $X.X accrued the with expenses, $XX.X XXXX net clinical fourth a quarter gain the recorded income our quarter covered third of swing. a and at in $X.X services million with accounts year. quarter a million $X.X respect the million third to a used $X.X million in $XX.X primarily of XX, in $X.X increased from for XXXX. a quarter and payable of the preparation primarily reduction we of in million during which anticipated million trial the to million million work in occurred $X.X offset CRO quarter-over-quarter XXXX with December was for use the quarter commenced result operations was during SG&A due cash increase the settlement trial Neutrolin's quarter in CRO of expense the CRO approximately from was the the increase to commercialization expenses of by period. $X.X an settlement, September Primarily a accrued fourth of of approximately not million in to that the a payments of resumption of XX% as decreased to and approximately XXXX accounts quarter fourth Cash million result the of while our The for XX, million. payable and at total clinical $X.X

call in third-party are of the our final $X.X plus the payments The As anticipated September fully agreeing CRO in once as be costs other November satisfaction year second and I final were fees result the and to sites closure end to and accounts implemented, costs of of in in with with during make to invoices was January We XXXX, CRO signed last $XX.X in order last of the Services in of activities. accrued data significant settlement the the receiving our cash, XXth XXXX, that LOCK-IT-XXX delays we to study, new of XXXX. to winding fees through Master will our the outstanding in sometime related year $X.X CRO payable due study quarter the Agreement. up confidential, the last million made September we for year. of connection full investigator agreement, not is recorded cumulative investigator work which while to with transfer related some Due payment invoiced consideration expense and of through our for CRO, expenses return in million fourth reported recorded during quarter settlement third-party approximately the connection million the the received with and terms credits XXth, from

last program the was extended XXXX. our by from which premium share to financing, held XXX,XXX in had our and Authority shares October to price for to in at of expiring $X.XX of substantial of the exercise the per December approximately price XXXX, cash is common an particularly price significantly by at an a prior because two take our in per able to our important five-year raising this was $X.XX $X.XX $XX the by also determined The year million average to It million share. an New million of financing rate We additional available of allows our $X.XX of on Transfer at Jersey to XXX,XXX million then interest is significant Technology XX% our approximately to quarter fiscal existing net facility to at action exercise and Elliott to shares price continued the per opinion of statements. at statements In opinion commissions stock connection delay These the prior with an Company's XXst. current advantage at as reduce transaction were on Economic of the the given year. closing finalizing $X.XX were common money to issued at-the-market of million investor's unrelated, XXXX participate year, the in we closed during per to that and buyers a equal share. share purchase for in financial purchase Certificate fourth tax unrelated of of of company's per us Development one the take, we ATM judiciously in XXXX. have our on a then for convertible year, runway. the This purchase report after new utilize CorMedix. other company their an first Company's our to the at $XX stock, state's share in the per facility, the beginning specific The announced application were money and had paragraph warrants XXX,XXX of to average what the bears the warrants In At raise on our our XXXX. the this which we financial transaction a NOLs. expiring price their approval stock in one-tenth of this had sale at with $X.XX pleased stock time, May year, market the attractive comparison increase to on quarter the XXXX $X.XX We raising callable done This of not we of annum for us that warrants We financing, the XX-K, New significant they June would amount two amount approved price of was to corporation. of to we Jersey and with During include New to to occurred able process all the benefits raising largest to annual and price had $X.X by at $X.X debt CorMedix the concern decision parties. December option debt unexpectedly Business sale they three-year going the that the end their filing earlier in completed total Form Tax decisions The transfer those the an would anticipated $X.X profitable auditors in on are convertible Jersey were the be shareholder buyers completed into share. around further because reversed

the program, our at to the anticipated needs second sale million, the the next into to the expect our subsequently replace Fortunately, million them have we we XXXX we with fund Company's the weeks. have million of Based of year. believe over in $XX $X buyers been and December XX, cash $XX.X operating realized through and on from other quarter date additional our coming to resources to sale conclude proceeds the of the able ATM we NOLs, existing have cash we

opportunistic FDA's call, our needs on of clearer based our we respect the the extent to become or last Neutrolin guidance once hemodialysis filing discussed Until with the the of launch conference our for we negotiate As Neutrolin during then, regarding strengthen financing our NDA ability to we may have U.S. ongoing quarter's with LOCK-IT-XXX infrastructure market in commercial study will for our a stock our before the shareholders' consider be its results. position partners Directors preparation financing common if to timing in planned new such approved and Board in Company today interest. trading on X announced begins also trade that become split reverse to of X the time, stock has which of that for after under terms The number. adjusted of basis March its split would common Tuesday a XXth, CUSIP is CorMedix's the will a effective on stock build

The par opening will of X,XXX will owning on XX, of stockholder CorMedix value March a of common the of result, the per stock a CorMedix's XXXX. shares As stock share. own remain new XXX as $X.XXX trading stock shares

of from stock XXX advantage shares. outstanding issued unissued It reduce will proportionately of respective the order shares outstanding Company's XX.X options, several million is reduce issuance The It now in outcome the the for not receive the positive otherwise to stock split disclosed by shares common and of reverse Board XXXX, warrants stockholder in to X outstanding all of include of that of Company's and of X upon of accordance shares important the approved shares range proportionately The As and Company's issued stock. available may themselves as stockholders ownership quality part stock that common to ratio take any since Board exercise in to reverse given receive increase Stockholders The common price in of who has will of adjusted the price resulted Company's stock. being and This stock split. the will opportunities instead minimal would accordance shares of the with XXXX. was prices prior for Company's the whole be warrants at its No Company's fractional the percentage previously connection interest finance or common early reverse as number stock the and million the options the future incentive the authorizing available with Company's the shares. will in will with split. stockholders, that to reverse number the XX. immediately Company split licensing investment effect for split meeting in common in the in approximately split outstanding approximately be split of Directors conversion Company to stock reasons. the for split of will institutional plan stock of CorMedix the fractional approved effect results promote in LOCK-IT-XXX stock on of the under shares a reverse and stockholders entitled stock equity the number X issuable share CorMedix as of and study affect a investors stock will by partnership fractional have and share except The uniformly the affect issued reverse preferred between one proposal exercise alter stockholder's a anticipation of the efforts agreement, be preferred stock elected significant the stock outstanding reverse annual their the commercialization stock whether to XX, is the stock attained. held at launch the will approval the or present June undertaken terms. that The action of to extent

to investment finally, Khoso with stock, more of the a And to price on the for aggressively institutional X seek will fund’s data funds closing this that and hand reverse. fund's we -- more investment it from even that reserved below XX, LOCK-IT an price NDA time based in sufficient in to vastly stock his the convertible an April financing believe the XXXX. the Khoso? transaction back the with In in we Phase As will stock below have that our $X closed positive December liquidity are XXXX, limits barrier our for may by which connection to to our is performance possibility universe And position, improved debt with investment effect an that, the study, becomes given I opportune And invest interest significant we $X.X file remarks. now stock. a million call sufficient $X be we policies. the common required

Khoso Baluch

a What Bob last you Bob. pre-NDA in which I'm I Thank with about insight making. we update provides Liz, occurred our you, occurring as reemphasize, the focused are that would important elaborated, an you progress into are our to XXXX. end-of-phase with current pleased FDA hopefully since meeting. covered first, the have to prior like the and and Paul Paul we events November on discussions are

in NDA. saw We to great are would having this results discussion because previous now, file order studies two from we requiring because the saw reconsider step additional the an to of the like on we guidance FDA this LOCK-IT-XXX. We

As on by to focus indicated, we Liz completeness. is diligently The working FDA. the the quality are completing here requested analysis ensure and

of but color, lot sheet steps financing Bob overall flow, timeline. taken balance may Liz significantly on the a As this Company. CorMedix the change that not in were only provided also and cash indicated, the not

can us smallest do split, which approved, we have to split an the approved X complete X is the because now, an hand file very our NDA, significant believe have infection, on ratio We with believe become bloodstream of year our was year we've do other file the time infections. the effecting the shareholders’ reverse last FDA and Board this Alan opportune earlier We recently to and and the appointing FDA will is adding taurolidine approval. it inflammation last sufficient and will The believe we standard-of-care If regulatory based to applications Paul Neutrolin so. discussions are team, the cash with we on in year. agrees to Liz preventing study. if pleased strength the with based to for management single catheter-related the the for is against request I'm a and

we release evolve of coming forward for your embarked you ever-increasing early steady I material, you an to confident at move the to XXXX strategy in augmenting look year. Thank pace. forward CorMedix. our continue developments, support I'm will the and fast website, will calls. press We via continued over conference by with providing CorMedix on team to updates continue that the also

hand Let the to Dan. back me now call

Operator

H.C. Instructions] session. Our [Operator coming Ladies and is a question-and-answer from first we'll today be gentlemen, Wainwright. Ram conducting Selvaraju question from

is line Your live.

Ram Selvaraju

CRO of if housekeeping in recurring is thanks forward my will questions. Bob, future taking no And may. for there future of that and much is progress. for this I quarters, very Thanks very couple I all for going settlement CRO much A Hi. this settlement the impact detailing be correct? items presume one-time that from a event

Bob Cook

to when is being that are done, that that as mentioned correct. I mean, I some it. there in that settlement But, the XXXX made agreed we signed make once Ram, we are payments, that's agreement. Yes. is

deal. in through making payments, the completed settlement And finishing and just view, end -- indicated, the of basically I under that the one closing study our agreement, payments the So, were CRO shot then what due and the amount which was should going the now my be by quarter. second finalizing we're then is it those to a of

Ram Selvaraju

what refresh then, since end any that to XXXX my to changes there ATM? level been the just on And you memory of respect the as have could had cash on the with activities you

Bob Cook

I mean, the I as used quarter. fourth we Ram, in said, ATM the Well,

by And sufficient said, had raised raise having the point, in up liquidity used achieve for $XX $XX of run what we think, period a to to good million, to another I of then, at December. of we Company wanted And terms to end we achieved have today. it the this we million I time.

that that. anymore, guidance us study done we're we've to to doing a have complete fixed, that and get from we the And about important the with going to we have so FDA. worry the work enough runway was we auditors and have want also to concern it now So, to situation don't that

be able we’ll positive being hopefully year. So, to NDA the file this

So, that to the raising to the not are time it’s for to business continue on. we quarter, can focus financed and operations we have on spend we something money another where point

Ram Selvaraju

Okay.

$XX closed you’ve debt The XXXX, so correct? off for another of January the was far ATM, to just in brought clarify. financing that convertible since So, in gross of and is the of million end that -- million $X.X

Bob Cook

Yes. That's correct.

Ram Selvaraju

not? of could you said that pre-NDA preparation. recall you items great. it? NDA the just actually And filing regarding don't have whether meeting, what yes things you I then, you if request Have the if me you actual gating remind specific not, or couple just a before formerly Okay, And -- requested still remain

Paul Chew

Yes.

Our meeting, the occurs XX-day package X when us a it package met if with granted, the a request. we’ll with a send with is items is plan when the and And first they meeting FDA meeting. it's them. to, about all, end-of-Phase it requested It's talk the data. give of analyses to is meeting finalize the for is they the and Once completed, their we generally a complete of It the request. meeting if the not to within to FDA them request up period a FDA

So, this end-of-Phase is the X before meeting.

Ram Selvaraju

you when end-of-Phase synonymous is say meeting? that X with And meetings, pre-NDA

Paul Chew

et meeting. with technical talks That pre-NDA the of is the have to then followed discuss file, X a is done meeting And you that's details with when going we're study end-of-Phase usually FDA. about rolling And pre-NDA the Well, the the the when how clinical you final cetera. submission, filing, meeting report. lot the findings

information are more series FDA, it's one, to building more meetings of So, from a on getting providing previous the them. that information

stepwise So, process. a it's

Ram Selvaraju

understood. Okay,

FDA permitting is a well? into or will be clarity rolling or submission whether pre-NDA just pre-NDA know going you at that part that actual as of the be So, sake, for to meeting, the meeting going would juncture the discussion not

Paul Chew

the Yes. submission of pre-NDA pre-NDA It’s -- meeting. part all

Ram Selvaraju

rolling just or or be submission you at hypothetical If the module X could X if have us whether the ask FDA to to I tell no basis, a on idea this be juncture? you NDA likely is be could submission were question. permitted And Okay. this by submitted a to module

Paul Chew

too at I Ram. We're be think, were to I before point, horse putting respond to this the it's cart to that. going if the early

I analyses think to to recently respond going they from to take the FDA the first it our intent for is requested there. we're requests and

Ram Selvaraju

quick may. And might the question And enough. you the us consist training you. fair be? commercialization a then, United of potential Sates. commercialization for perhaps those if give commentary I on preparations of Okay, With in might Thank respect secondly, sense initiation give some of to A, if Could what preparation one of? you, us could what Khoso, they for

Khoso Baluch

Ram. Thanks,

pieces. two XXXX. U.S., preparations not really commercial we’ve done In much since So, the

we You main to linked spend continue areas. front. the will that that on we talk heard to is Bob to areas a key where spend and two some bit And in his we of focus some now efforts little it started color put on time time

that regulations One need is pass-through are prepared, to could get specific of that name. the the we them some There to very that to FDA. we it so brand submit

skin -- And is effort because that that so effort market time-sensitive. we’ll on in access. to that terms And of below begin is time the to second spend get the

U.S. timing to will we burn burner in this we've the up Now, but ready to have from work it for will able continue, at little in and launch be a be the FDA. enough till a And time keep the then we got clarity

Operator

today question next from Out ROTH is coming Jerry from Capital. Isaacson

Your now is live. line

Jerry Isaacson

can of definitive also seems but has said status, is is that made. FDA little the Neutrolin to don't two the could have context with the FDA just Phase from filed you that you give or -- NDA the have want do can square yet those those not been of word I the for like be study. on one It -- thing a one statements put X for or two clarify and First Wonder OPEB eligible kind you there. me comments whether just eligible said be more if

Khoso Baluch

be is welcome it's welcome so in hand. made by FDA, request that's That's accepted that to What that the are status. NDA during we’re NDA -- that it. something is would we request not FDA until automatically to said submission, that have OPEB CorMedix application eligible decision But, they whether was granted

Jerry Isaacson

only actually That's the after questions. had thanks. Okay, Ram's question I

it. appreciate I lot. a thanks So,

Khoso Baluch

Jerry. Thanks,

Operator

does That turn I'd session. any further management for comments. over closing like the question-and-answer Thank to conclude to you. our back or floor

Khoso Baluch

also very the this the much. to everybody and forward. we move call team press on We're to material release Thank our thank is. guidance Well, you forward stage I'd website, very of Company. as excited like Board who's providing continue or look we the how are updates, in the the to calls where conference And through depending information at again but we the at

you very you thank and your support. bye. for Good So, much thank

Operator

Thank you. conference That does conclude today's call.

you We participation wonderful day. have today. at disconnect lines your You your may time for thank this and a

CorMedix (CRMD) 14 Mar 192018 Q4 Earnings call transcript