CRMD - Earnings call transcript Q3 2019

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Operator

Greetings. Welcome to CorMedix's Inc.

Third Quarter 2019 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded.

I would now like to turn the conference over to your Dan Ferry, Managing Director from LifeSci Advisors. Mr. begin. may you Ferry,

Dan Ferry

afternoon conference to call. Good quarter CorMedix XXXX investor and operator. the welcome third Thanks,

Bob Officer Leading Chief Vice Executive CorMedix. by Vice Executive call President Officer Chief the today and Operations. of He is, and General President is Jack Mounts, Technical CorMedix; Phoebe of Khoso Counsel; Baluch, Cook, Executive Financial Armstrong, joined

projected capital about financial statements Neutrolin and projections expectations, specifically, manufacturing as as the projections any position, and include costs, Company's the future as licensing certain revenues Before expectations the Private are regulatory plans set and and component may actions, make and management for forward-looking any during or statements other transactions, including the we program development and to begin, timing, call spending Act future possible product meaning Reform to, Neutrolin than our candidates. as I costs, include, any its management's product and candidates, to other in Litigation other subject uncertainties limited the position, would historical market for are statements and nature and the costs. of Securities the like thereof, forward-looking cash known of Any to product regarding expectations plans fact forth statements within in future commercial and Company's following. results, market remind product clinical and risks everyone prospects, that These timing but product the More statements raising, of anticipated statements and business goals, development what not expectations, XXXX. candidates, clinical of of our and and are other interpretations U.S. acceptance to potential to and development beliefs, the about plans

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

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

Khoso Baluch

Good Dan. you, Thank afternoon, you everyone, our for joining on thank and us call.

continuing On segments. will cover to call market our you and market to we LOCK then catheter first in today's the efforts other Solution for Neutrolin with US patient hemodialysis earnings bring as

Jack and Phoebe Bob, call participate. this So will

earnings We first we update for progress will the that be I'm we delighted the significant an Neutrolin. topic on we regulatory that NDA interactions and made last pathway report with would the completed CMC during the call we've the have four pre on stated board, FDA our discussions covering on the to do.

FDA but get will previously. covered will overall into further had stable the details we that on Phoebe items supportive

the the LPAD. review For submission and priority example rolling

FDA we in the CMC during call August, and with NDA two XXXX. our both quarter recall in we to that may you quarter have As pre earnings stated plan the interactions have the

achieved We goals. those have

what in achieve with distribute we manufacture to progress chain chain we've cover establish do you use to with commission, we for the made the to those previously will the for the market. CorMedix interactions we made XXXX had also we've Neutrolin establish and progress goals the review with supply will that We U.S supply and

meet to from path recent the also prospective. how has we're patients discuss and care evolve the hemodialysis taking over a needs will those the product of We steps

we facilitate on to undertaking update in may our balance clinical expand addition sheet. product Neutrolins made we've the also practice with offering the better In progress improving that will we're finally cover the you we in work further different you will setting. And

to will detailed much we've the We past, you in information the XX-Q we in the available review as not to today. file to that plan going as is for done

So, let's Phoebe? get started with Phoebe first.

Phoebe Mounts

here the required to you, Thank a on pleasure to regulatory for activities made secure It the in continuing report is marketing Khose. on U.S. back be again we've progress authorization and Neutrolin

method call of use mind including During insure in important drugs to that it to and drugs extensive the and the keep to NDA manufacturing emphasized identify, addition that require strength I earnings drug the manufacturing evidence maintain purity. the quality is the the in to controlled use information to last clinical the

information obviously FDA will insure at to scrutinized FDA drug manufacturing how on describe the the to product prior safety is is closely a and drug chemistry specific in The are manufacture there no must design be proceeds or by regulation to as which formulation manufacture not detail that approval concerned. dependent of do a drug. efficacy

to Just and effectiveness clinical FDA the with support on CMC discussions as information. data have of engaged been Neutrolin agency and we with we safety on engaged have been

a likely distribution Manufacturing needs demonstrated commercial reproducible subjective quality encountered as with and of the to ensure a data be product. the conditions to be be shown to in drug Stability must and to reliable product validation is extensive through product study. to be

address the have As to ensure expecting that We feedback FDA believe to we manufacturing from and and all data in can important support may experience drug have. it is any agency that four guidance the that to question FDA generated substance NDA. proactively quarter expand is been from developed data obtain and saw of the the the product CMC information FDA that to on discuss have we are drug

CorMedix be that As the XX, provided to indicated CMC we need announced the for the press in program release them. on and FDA data through guidance will available on NDA October

what Neutrolin. it meeting for marketing means will Jack that for authorization and color now on some of the provide further securing outcome Jack?

Jack Armstrong

chemistry the the on as with Thanks, the manufacturing The Phoebe. controls. interaction CMC known FDA

indicated, the work the Phoebe important NDA critical as in is needs not and time NDA and to depending the completes for what the on short filing. is to the way requested chromatics As assure

our for action core release press with inner for the very NDA drug FDA of the was the the processes ingredients active as positive. outcome manufacturing indicated the FDA inclusion October XX of product of supportive part As pharmaceutical of submission. was the the our and

module information we did review for a FDA manufacturing facilities the to of various at additional review. FDA. the as a of all did optimistic with indicate thorough well the submission. which so time No will of complete, plan as working the request readiness of planned data CMC the CMC filing CMC completed conduct the are NDA meetings with that FDA some the it we're that assess to further NDA we prior are commercial the FDR

Phoebe? that the With this cover other we summary quarter. Phoebe me to milestones let pass floor back regulatory achieve the to

Phoebe Mounts

Thanks, Jack.

on assessment If the the critical FDA, day for NDA content Insuring the of As with I submitted complete, the XX period. information with meeting didn't agency on be the review product. meeting the mentioned FDA securing the pre essential of fourth We receive in file in NDA. submission. have not cause in quarter. The addition refuse from see an the and the finalize actual When on FDA NDA of submission authorization preparation the responses FDA in determination FDA NDA the accept for administrative is CMC to NDA the meaning its conducts our NDA. details for earnings can NDA format A pre question refuse required to the and of call, filing. our NDA will of is purpose appropriate to to most the significant last meeting FDA the the the to the file to the we a for delays to NDA to FDA plan to NDA have for positive pre agreement

eligible But First, within CorMedix of or NDA Neutrolin is calendar If garneted. request the for and for for review of months timeline. of absolute then review goal period is with by FDA FDA review XX the priority days months. review. are review priority if designation the not agreed Accordingly notify the review has to will clear to FDA under include agrees a XX just is CorMedix period the priority goals priority to FDA NDA. review instead receipt intends NDA of that the period the six be

NDA to for review eligible that proposed is is and reasonable. rolling investigational FDA drug to file Secondly plan the rolling new needs now a formal Neutrolin to application. the existing submission the agreed CorMedix request review

request is antibacterial it that submit Neutrolin under agreed FDA to antifungal for test for or limited approval population drug. a LPAD appropriate and Net of

in the infection of a whether to prevalence treatment pathway determination submitted for drug flexibility account recall NDA LPAD from at the clinical intended that population. the make FDA of alternative drug pathway drug new last limited for will the limited this meets determination is FDA LPAD and of the data for time whether effectiveness the that may for and previous in relatively safety of population earnings the for demonstrate provide adequately and FDA into intended whom criteria additional call a is takes its of the in with the treat Neutrolin You is use. the severity the and the the approval.

which us the in that submission we're that able and efficacy adequate review data being specific on support cannot for NDA. that us support now this submissions center size submission data FDA large for it and that so used set is additional LOCK-IT-XXX system FDA the guidance there a that determine a the this with indication. trial electronic it grateful agency and of narrative perform be and that has electronic issues to Next, evaluation for data no will single The drug a well-being. sees of provided a in NDA handle this assured seller handling some reminded to research of until expectation terabyte will the are safety

product. provide previously have we are effectives noted required the substantial and of controlled well evidence and safety usually of trials to As to adequate

the data of study. preclusive CorMedix the information believe top provides with and line CorMedix moved receiving we've from that the unwanted is end NDA. benefit. over interact that to clinical single frequently the and to highly provide from on FDA analysis submit Neutrolin very the prepare a XXXX, quickly months diligently based NDA Since January the the working XX to LOCK-IT-XXX information reliable LOCK-IT-XXX the robust past for required to at demonstrate

we information on the Neutrolin excited estimate for I'm the needed earnings our the internally progress to marketing XXXX. last developing second covered a about to authorization the U.S potential that and successful. schedule remain have team for based approval current half NDA to submission as call, be the and confident and remain we secure we've capabilities and in during Therefore, on of during

for neutrino pathways NDA the indication continuing on from indications TPN. for in or inductions for the options use addition developing regulatory with focusing in LOCK-IT-XXX first requiring for and to hemodialysis provide of for use, on for use Finally we will preparation patients we We're in indication it for working because for data patients hemodialysis the additional oncology for more securing additional a are believe data total the the clinical you. generating with patient the

As for program capital need part be the a develop planning --solution. new as soon inductions to one, of to

in We discussed few we been experience the have using minute gained LOCK-IT-XXX as with a

I With you the call to to provide Jack, the would on who supply that, update chain an like back for will turn U.S.

Jack Armstrong

Phoebe. again you, Thank

manufacturing enable noted outside carried product for the five selling During and Neutrolin three out last manufacturing CorMedix that manufacturing technical the call, successfully validation sites. is been production the I process of last different at transfer successful We've US of the and years. which the is

quality I requirements previously, the competent needed me mentioned is team, experienced for sourcing, and the that very a necessary and foreign in and for have assurance have with manufacturing, and both breadth US the As distribution working depth they markets.

distribution last with or of we initial earnings America. finalizing The finished for volume the product launch qualify product will more be in contract the needed the Europe. US meet call, and our Longer-term, third-party of Further, supply network in forecast, North product our you manufacturing chain market. in site the to based be covered site I US. at we in initial to to the supply used are now that will that be the manufacturing the for expect two During process order on to manufacturing we manufactured forecast preliminary for second in a plan

nothing make US comments literally I would in the of So because, that with with to several in had US I to sales the use regard since additional establishment the we establishment supply no the CorMedix chain. like before. place started background,

chain. like Hence to several place no distribution establish US With I'd in for mind, US. address supply, that the network the supply things about there key in are

began elements we early some in the place ago cases necessary. supply to practical as on working that are First, critical several US and as years ensure chain the in

for have set for continuing of which bars substances, drug that development. pig We're the supply as be due up API in chain Chinese pharmaceutical the we outbreak also Secondly, China. track to active two light neither will APIs. of active sources sourced purchased the from the in heparin, CorMedix important shortages mucosa. of recent will the ingredients, swine known This the to

various items. in validated has to our manufacturer, launch drug master testing has enable the needed drug taurolidine, source has been in processes network which and appropriate logistics that's taurolidine manufacture CorMedix and established place the and have is the its own to Fifth, the [indiscernible] Fourth, file manufactured completed Thirdly, is for product CorMedix established quantities. U.S. validation move of

third partner. our distribution For the selected XPL, have logistics party network, U.S. we

the Our and our to integrate will systems. take customer XPL in up planning to do setting cash financial database, to orders, will ship order assist and customers,

the chain. Just one last comment on supply

are process internally, forecasting We appropriate external integrate and ERP planning as an the with system installing in to with of data quality systems financial our and partners. the systems

supply schedule. remaining to are and the a portion ready items the So with significant chain, in summary, on regard is

turn now back call the over Khoso. to will I

Khoso Baluch

the Thanks, next into describing and important continue we you the Phoebe phase Neutrolin. CorMedix clearly Jack as for responsible move to are for forward at for work

our market downstream updated via look turn attention let's Now at further lens. an the and

some Neutrolin time now, hemodialysis delivery been we've option optimal the the at carefully looking for patient. For in most

trend from of vial. solution patient for how using vial, examined the session, per for each enough began that of administrated. was both two we growing As data sites we the Neutrolin in LOCK-IT-XXX, instead one after dialysis that we saw noted Shortly Neutrolin the lumens there started, LOCK-IT-XXX one many carefully vials catheter despite was fact one lumen per

for this learned more more more that practice potential our once. educators only By speaking We the by infection which nurse As sites. many practice each was ways looking and to the progressed, is practice we study vigilant penetrated this syringe began is and from recognized vial Dialysis once, with and where vial about is of one one needle sites being adopted the drawing each always adopted. only has the control. risk why lessened, are units about of infection be been more

one help the package have that hemodialysis market Neutrolin's to upon with that approval, sufficient that this present any a would So be per the vial each be lumen. we compliance higher with vials will in mind, fill to should standard Therefore, will economically. a we a patient used maintain two pre-amount for session for ensure

segment In addition, be catheter million solutions of per estimated that it the market the hemodialysis year growing. during stated and the catheter size last lock solution the earnings was to $XX lock in for doses around call,

each central lock our vials venous For vials, hemodialysis clarity catheter the that lumens sake, catheter each, million given two session. two represent XX for in million XX estimate solutions used have of actually annual

which the very different. CorMedix for need a undertaken, vial and delivery product needle-free introduce discuss segments Based delivery has to And developed. that for additional we market. the the the launch Neutrolin plan therefore see like extensive therapeutic on hemodialysis being oncology product the segment, will into for the that systems now hemodialysis work oncology would we We are have is a syringe. I we pre-filled, markets in once to

value needle-free pre-filled, a supports the market syringe and community. adoption the Our that in to research would segment oncology provide support medical

sheet. the during me we've balance let quarter Bob? Now, improve the cover at taken to macro a Bob ask to level our steps

Bob Cook

the ended our quarterly information nine the company in complete more to for contained The Form a its filed months urge on Thanks XXXX. very you report September results. XX, much, quarter third read I discussion for financial the report of Khoso. has and today XX-Q

connection stock outstanding of certain company into convertible claw September notes convertible D exchange convertible depending to the secured a managed is for The of agreement, agreement make Management recurrence million stock closed payment series the of of $X In and subject new the XXXX, by and to the aggregate CX and F million senior common all stock cash price XX% related back, an a Corporation, an convertible series shares Elliot In G preferred a convertible to its exchange with preferred funds exchange to Elliot series investor. its largest stock, agreed conditions. new warrants of preferred X.X about stock. G upon with

With the stock. to the preferred classes to of completion raised of of strategic as reduced capital as as closer put bringing CorMedix market. U.S. well eliminating outstanding By the the arrangement we negotiating we debt, this additional position exchange, the we warrants move its and company for a whatever substantially may stronger outstanding Neutrolin prefer in amount

of dividend was The deemed agreement, the result of exchange of dividend $XX.X comprised four deemed a the a company As recognized elements. million.

at related note recognized First, the beneficial remaining the convertible to conversion extinguishment.

fair G and values difference of series series preferred CX value issued the between D stock. Second, stock, of the the preferred F the series the and the allocated preferred stock convertible the series note, carrying

the between value the the warrants series the exchange fourth, after exchange were and of E Third, as the the of fair agreement. of before part And and warrants stock, value that difference series the preferred of carrying fair difference fair E exchange value agreement. less between value the cancelled the the

which of the was The no million of carrying compare on the significant transaction effect was to old to It deemed on equivalent books. the to carrying work amount cash. series complex and the case the not the The significant fair of on old the new for indication of a plus As because to instruments, instruments this value each accounting and values instruments, amount required is cash. the fair value $X in had dividend value estimate can old market fair the you value deemed old instrument. the those of investor, the appreciate, of incremental in value essentially basis and an our of value of against the of G is the given dividend

during in million efforts in warrants $X.X million. cash transaction, $XXX,XXX. deemed the warrant expiring proceeds Also the warrants agreement X.X exchange other investors capital September along the to company $X.X the its structure, another the and generated third quarter their in this during the part on company completing approximately XXX,XXX this gross of in dividend exercise of to held purchase reduce in receiving and the overhang The of company million which to our agreed approximately price In recognized Warrants with of year continuing approximately $XX currently approximately of quarter by August for immediate exercise, with simplify of the outstanding. as warrant year, company's strike reductions, resulted reducing XXXX million return are shares. price shares this exercises

on cash short the of for into company's million hand NDA sufficient resources fund preparations has of launch. Neutrolin it company for to amounted submission XXXX, to The excluding and investments the XXXX, resources September XX, million. including September at and the Total term that on of initial cash as based commercial cash believes XX $X.X $XX.X operations restricted

relatively our XX, was covered XX so with this million we earlier, hand I spend June low, compared As in approximately cash at quarter at million finished September with XXXX. $XX.X $XX.X on

begin starting as and building burn in key to to early expect We for our inventory we personnel commercialization. hire launch for rate prepare increase XXXX

the shareholder to would the base. continuing you other of to which update evolution The company's relates topic like on I

filings believe U.S., of analyses on is its stock by a continued shares recent XX% executed equivalent Russell basis, including stock we for receiving diluted was approaching we in significant along held placed of in Neutrolin have the common and reverse institutional common undertaken, fully ownership XX%. ownership several marketing towards a split increase approximately and path have a into CorMedix As that funds. institutional shareholders, the the On and is and the of institutional outstanding currently Based Index, number company other BlackRock investor seen shares outstanding we warrants. approval

institutions are as filing institutions funds, shares are along to we which index engaged actively the with our more While ready investment have also CorMedix managed NBA several funds added with appear we move by Russell who and Index, the re-entry of toward approval. positions and take hopefully seeing into

focus to our investors. a with effort continue and We with messaging institutions healthcare emphasis institutional particular on

call Khoso Khoso? to like with I would for And that, to the his hand back closing remarks. now

Khoso Baluch

couple are with months. progress to Thank you, Jack efforts occurred and last the hopefully points. the insight of and I'm pleased I'd work the about have three which What covered that focused provides over Bob like Bob. we into you are key Phoebe, a on making we you reemphasize

extremely approval along transitioned a completed help as of care presentations supply team of approved standard portfolio the forward our to report CorMedix CMC are on Both have Jack We into and to CorMedix to making have is half planning will during NDA and of the and market move interactions are product today's The shareholders before needle-free chain the moving prepare from track. to and will the from were the progress user second get Neutrolin introduction with standard pre-NDA the planned. effort process that the providers friendly, to quicker. new the this Neutrolin the easier for regulatory marketing pleased FDA the U.S. pre-filled, positive to with his is Neutrolin the the Neutrolin away care receives hopefully FDA. XXXX. to of The syringe

the bringing additional partners increases cash without attractiveness was our the of increasing diluted section and equity complexity We balance common believe reducing to of sheet important. fully our stock in potential

and well-known is retain independent for with to to trying of new available companies new to of allocation several fall expert stock company proxy. Finally, The programs attract, were amongst proxy based issuance for of we years. talent shares additional proposed address needs appears received some that by achieve. there top that the company Meeting a the development. as recommendation questions size X the plan the growing we that the cover adoption over misunderstanding stage forward. to next have is for some issued what intended our We is who of guidelines General the allocation compensation since It approval. well the to annual see Item received the The meant plan our questions needs and announced move designed stock The help the pleased upcoming on IFS reward company's we within and is of acceptable minimum of plan a was shares a

In on trial studies specifically hemodialysis the oncology discussions design segment. and the connected catheter LOCK-IT-XXX the we're after for NDA oncology Please one. are lock for to use all working step TPM. terms patient develop additional of with the in FDA hemodialysis clinical note is goal for this for to been these receiving, of update Neutrolin use indications filed. solution CorMedix, and have protocols had for is as We've the regulatory that TPM, the are to just At with groups finalizing the determined seek Neutrolin in you a number and pathway

are at open Because Our the market, shareholders' time segment hemodialysis CorMedix Neutrolin the same All table. while potential payer to the in a hemodialysis is being is goal to continuing launch very value. to maximize options to provider concentrated on we are prepare partnership.

continue D.C., We all whenever to levels with is dialysis provide on build Neutrolin Neutrolin and the Society of in Nephrology just for Neutrolin, at major organization. and their last updates we week met ensure providers that of at to American awareness

a be may place, to the and particularly who best very player and of able are shareholders' be areas critical than We may value. a therefore strategic larger, also acknowledge that in more appropriate such broad, TPM is maximize care in already more place oncology,

become standard that I in of care is approved, for bloodstream if infections will preventing hemodialysis the it believe Neutrolin the continue patients. catheter-related to

evolve moving team over we pleased of our XX As strength the of last Phoebe coming the Neutrolin the regulatory covered, have to the been team with will the areas very our through I'm management productive required months augmenting need. very and in in continue by quarters process. strategic

some As in our a CFO we a have search a new I days for with stated begun top XX firm. search press ago, release

to This for the call I'm concludes open it to our operator going hand questions. presentation, back the to so up

Operator

[Operator question Consulting proceed from question. a Instructions] is session. Please this will At first John conducting be Novel question-and-answer we Ledon, Our with time, Group. your

John Ledon

Good afternoon. Thank the for detail. you wonderful

Can the the the types the past it done that, and that future? previous products. mentioned work how on pipeline, been of been in to you in help the meshes, of In terms other in products that'll sutures, speak other has that establish you has

Khoso Baluch

Thank you your for very much question.

made In terms in bear at bandwidth filing progress moving of over we've Neutrolin not we've to and resources regulatory submitted it our NDA to the written and goal all to quarters, attention on the to our NDA that the we has effort pipeline, our FDA we've been turn before is the on pipeline. beeline present got -- really to put what get begin pathway. few ensure delighted now spent with is the the and Neturolin last to our much back We're the

John Ledon

in early that Thank some of level had development for understanding stage. I'm But you in that. the under that prior experience with of you have prior studies terms or

Khoso Baluch

work into on neuroblastoma and was in particularly late and presented XXXX already, and that website. ASCO that XXXX our available did in We Correct. with is

John Ledon

Wonderful. Thank you.

Operator

will back session. We questions and I the have over of call reached remarks. now closing Baluch to answers Khoso the for the end turn

Khoso Baluch

best I'd forward look Cook, and our of our the the to his luck his embarked services thank for services. to I to life, three website over Bob years. want I chapter to investors on I in for of forward. We make we release wish CorMedix. like will Thank next appreciated much last you to him I in with his and the this effort press thank CFO very all want nearly take his updates via conclusion XXXX call. and only both early our you strategy the continue also conference development is guess very move on much, providing supporters Dan. the to opportunity the and

very Thank you So thank you, much. Bob.

Operator

concludes conference. This today's

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

CorMedix (CRMD) 14 Nov 192019 Q3 Earnings call transcript