CRMD - Earnings call transcript Q3 2021

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Operator

Good afternoon and welcome to the CorMedix's Third Quarter Earnings Conference Call. Today's conference call is being recorded. There will be a question-and-answer session At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. would Ferry turn from I over conference time, Daniel to LifeSci this like the to call At Advisors. Please go ahead.

Dan Ferry

Good third Phoebe Vice Counsel. quarter of CorMedix. the to Mounts, Vice President, the Executive conference and is Financial Executive welcome Matt Leading Officer Chief Chief is call afternoon call. General today joined Executive President Interim Officer He and and XXXX and earnings David, CorMedix’s by Dr.

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

Matt David

as first we additional roles thank Xth. on call. on the taken joining on you and announced and this Today since October the everyone afternoon for Phoebe Good have us marks call I within earnings company,

the reduce a company first be market for catheter-related lock bringing DEFENCATH a patients CorMedix progress for hemodialysis and month, catheter updates, pleased the today's over to solution is we quarter busy its this for incredibly CorMedix to third reflect On making as we on to XXXX our financial indication months. here information priorities are to been the earnings has discuss discuss U.S. as the well it use bloodstream coming in call, as infections. overall While as afternoon will

encountered CorMedix the DEFENCATH with that CMO topics were its discussion issues we that that unrelated delays there September, contract CMO. activities. by the begin are In announced today. for Let's third manufacturing at to we informed or party And had were manufacturer

progress we shared team that presented incredibly and the couple we that CorMedix A an in we some of balance you for progress that deficiencies Society specialized are abstracts recent that approval to epidemiologic have CMO that provide CorMedix's of group our work this data and to We uncertain. information ago to on work are bring the efficiently The cash the our DEFENCATH resources last and DEFENCATH, received. FDA pleased cap will for update. and defense Care since also The will our Association preparations U.S. provide update timelines to tech from the sheet. including a while defense with Pharmacy has team, the of to in October, strength third in important. indicated when of CMO I of we of now this that regarding Also, facility required the our balancing closely making continued patients Phoebe has is quarter for limiting and consultants, are these launching the stem the Managed the front. American XXXX market on abstracts we with so on became financially, at Nephrology. share are are required a here color address weeks conferences, provide resubmission CorMedix two financials analyses the described NDA burn our

how bring DEFENCATH these for life-threatening additional the as work the items color they community are who CorMedix. we provide risk to infections. at patients bloodstream prepare and As purpose underscore these are doing at to we to data here hemodialysis of in use catheter-related I we plan on will some

update to will the Phoebe? the Now, let's manufacturing move first Phoebe provide regulatory and topic.

Phoebe Mounts

manufacturing of Thank afternoon, pleased and contract on Matt DEFENCATH process. able that and work I am third the you, been party manufacturer, report good resume the CorMedix to everyone. have to validation

September, the CMO to result that issues DEFENCATH. unrelated we Matt, were manufacture as by of that and there early noted a a the As disclosed of in delay as was

identified is been to address to required resume are the able FDA. continuing work have the to activities by deficiencies that We the and manufacturing complete

manufacturing discussed Specifically, that deficiencies at adjusted, After target DEFENCATH had FDA the CMO, regarding specific volumes. timing time available the Until we we of for be able activities drug the parameters testing It will required. for vial of and the particular, will documentation the filling testing, we preparation we the require line all up data, filling new and resubmission. complete was the application of identified of filling determined resubmit were or some DEFENCATH. analyzing to of not with previously to NDA completed of in involving filling module operation qualification associated have that guidance operation to give the have to

asked diligently DEFENCATH has not the data to to relating from resubmit the any CorMedix we clinical As will information LOCK-IT-XXX resubmit study. the continue that to you a reminder, NDA. assure working I been can

As we an providing are on resubmission update have stated we on coming the will have committed timeline. previously, when the updates clarity provide to over we we months and

for sufficient will requirements. are We FDA demonstrate to to to the Approval have who fortunate CMC of to NDA well-qualified facilities with require FDA's also regulatory operation to the to DEFENCATH. that by extremely resubmitted working been have module data ready have support CorMedix meet us manufacturing and be consultants been the ensure documentation commercial and experienced

resolution evaluation facility the of have for all the resubmit by intend To to the our the sufficient will manufacturing the FDA ready CMO. is facility operation required be in-person of convince data As and FDA us by is that prepared DEFENCATH corrective manufacturing explained, NDA. to manufacturing CMO for action an the FDA be goal without be address manufacturing post-application informed facility for an the will the support the by for resubmission the to of FDA and submitted to the verified CorMedix we during remote to that of actions for resubmission actions commercial or that an evaluation letter to the Corrective on-site of six need deficiencies FDA be identified sent FDA. We CMO the to the CMO deficiencies model to interactive inspection. informs may at of also facility NDA. subsequent in documentation

work FDA are Matt? by medical review the that unmet address catheter-related in financial for and call the infections. cover turn Matt Thank to back conference DEFENCATH life-threatening guidance, cash recent activity. with to will hopeful an the consistent need will NDA reducing potential quickly FDA our the bloodstream recognition to now you to industry I approve of We and and results,

Matt David

Thanks Phoebe.

of as report XXth, on on results, provide third XXXX. overview our Form September has a information filed ended our company more of and an results, update respect has in position. quarter million of the I to financial third quarter XXXX. The its With contained XX-Q CorMedix's read for financial as quarter complete $XX of our well financial of for report cash equivalents to third the I'll the as results. September you Next, company discussion XXXX XXXX urge an cash the XXth,

$X.X decrease approximately XX% an costs, approximately personnel Our the The loss net for an additional studies XXXX. our its $X.X increase costs expenses a non-cash SG&A with a a loss expenses XX% to to XXXX with lesser fund R&D launch as increase . million months XXXX driven expenses of in for XXXX $X.X DEFENCATH initial approximately of of quarter $X.X taking the the a in our marketing of net by in non-cash in costs operations to $XX to compared decrease in personnel an stock-based R&D increase decrease $X.X flexibility in the X% increase quarter XX% expenses first expense of third primarily lower NOL by efforts, for of R&D cash for sheet months recorded to XXXX, approval was compared increase offset an the XX% increase higher and in during compared to of in for million potential driven well CorMedix We per our and increase optimistic the associated of in XXXX the a of increase non-cash the used nine of non-cash amounted resubmission period recorded compared recognized share commercial DEFENCATH third million, offset $XX.X compared related charges through year-to-date X%. loss and third third NDA increased to million, perspective. for million XXXX hires, XXXX XXXX. expenses stock-based XXXX increased manufacturing to compensation respect in or in With to $X.XX $X.XX in with the for nine expenses. in operations increased XXXX. by accrued the after potential charges and The in of consulting with increase net fees. an in XXXX. per compensation. or share $XX.X of financial nine for million million research resubmission gives compared preparation to of by $X.X related nine in $XX.X an driven DEFENCATH increased result with approximately total compensation of million higher prior of prior DEFENCATH from larger primarily with stock-based by extent, XXXX million compared believe at preparations by in consideration quarter in costs million cash NDA net in expenses manufacturing $XX its DEFENCATH a net $X.X months balance used R&D declined about our personnel $X.X million to the FDA. personnel in first toward with during driven We an of remain of increase with and an the same months and of months to the XXXX. increased operating to Operating in the marketing first of related a period cash higher XXXX, its the in nine decrease expenses. to nine costs difference of net the expense continued We position equivalents months million the of was approval included SG&A partially as primarily of to progress stock-based approval. versus the partially same marketing as increased in compensation. in a increase results, and mainly as company loss, quarter goal remains expense received We of a manufacturing by in the in sale an This expense potential from the least result SG&A operations cash charges compared increased charges XXXX the by and market attributable an the the approximately into strong million and to for a was net the

believe and as given we cash year we us CorMedix believe to we capital in mechanisms our to hemodialysis potential the future, as a current raising, As for we patients well and for bring to highlighted to will us available allow be the are for seek ahead DEFENCATH hope previously, that equivalents setting. what approaching as be pivotal the prepared

of presented abstracts Society As for highlight topic related especially were important organizations patients. retrospective start and infections. patient metrics and findings and at venous Conference. catheter today, week patients to abstracts presentation to Association in understanding clinical These at bloodstream conclusions mortality our approximately Conference, to We two Nephrology industry October like since announced CRBSIs efforts XX% expand in claims economic The related of accepted a the catheter-related track October from conferences. at analyses in third These the the these The retrospective of Care had one Nexus American setting. disease Pharmacy multiple CMS CVC or two three abstract would our and underscore significant and Managed quality these hemodialysis presentations renal to highlight hemodialysis care that and last that integrating presented include that I central the conducted CRBSIs databases in infections studies CorMedix or of end ESRD or to are undergoing a incidence use as in with costs their stage months are CVC XX% occurrence three in CRBSIs Key XX% hemodialysis the within patients significant lead longer a and of these first hospital is billion more they with months failure, infarction, significantly admission, patient dysrhythmias, cost cohort and died complicated There the Analysis estimates of only of CRBSIs days in risk they XX,XXX hemodialysis common, clinicians for patients stroke. had but patients of the Approximately are these from associated The CVC event. $X.X this incremental incredibly insertion. stays, over firsthand insertion; direct of findings vascular course. clinical approximately CRBSIs more see challenges from within mortality. include Not the CRBSIs from population. annually. and endocarditis, heart myocardial CRBSIs the infections within occurred following been and an XX access. post-CVC feedback caring higher stemming CRBSIs as died XX% to three in has complications also of patient CRBSIs supportive, first XX% dialysis

incidence alike. CRBSIs CRBSI to had there providers, available in payers been as and regarding we hemodialysis burden CVC the our As the associated magnitude U.S., significant team of mortality of been incredibly patients, elucidate that proud of work and among minimal has doing are comprehensive to patients data a the the

with As payers, U.S. including care. we CMS leverage we continuum speak seek approval, continue the across as to providers to hemodialysis bring inform to to to our the patients we will of prepare DEFENCATH these and in similar work following data messaging, this and

reduce of that in that to unexpected bring To need our encountered such remains and level patients focus significant following. can of to market, steadfast summarize we team delays the pathway morbidity Phoebe on CRBSIs to are continue today, the and our a I contribute efforts have what discussed mortality. commitment these who to have DEFENCATH to our in CorMedix we in Although alternatives

NDA the can First, intend as we deficiencies, the so be to soon manufacturing possible. that third-party expeditiously resolve as DEFENCATH resubmitted

plan NDA our its addition, commercial understanding In Also, such opportunity of we TPN, have of while of continue DEFENCATH are for once introduction to a approval variety continuing oncology. by of FDA. as for balancing and opportunities hemodialysis carefully approval following broaden our the burn, across expand settings are we preparing to and to DEFENCATH cash we the the

to may third-party by Finally, the bring FDA been conclusion, to and and of have that we technology we the place patients. U.S. continue value strong confident in have [indiscernible] resolve that aim to it DEFENCATH to our in identified maximize resources in where patients the the In team deficiencies a we areas hemodialysis appropriate manufacturing remain benefit

of process. Thank continued interest call We your will in open to the for support this for you Operator, CorMedix. questions. please throughout updates provide continue and

Operator

question conducting JMP Please At Instructions] of proceed be time, with Our you. Butler this question. line your a Securities. first Thank we'll comes [Operator session. Jason from question-and-answer with

Jason Butler

guys and Hi, And are we as alignment items? that there it to thanks read this updates. -- needs in on interesting, two-month you complete to the be that progress to delay the work then either I guess be asked about? announced still as other and for or before, Should that completed how congrats delay you it's the taking factors address a think CRL is I how the are essentially think question, had on first that question that with important September. CMOs mentioned back appreciate work full questions in and you and done I CMO you keep should -- work that first the into in you needs be we but the to the to to the

Phoebe Mounts

This the the facility. affect over couple of did of months, delay it for us affect is thanks in product, didn't our question, Phoebe. The the but Jason. Yes, past terms

our possible DEFENCATH And it to was not manufacturing activities. us so for continue

However, deficiencies. other the address aspects some the there ongoing work of was was of other that to obviously

specific manufacturing So, work, were activities delayed. unfortunately, was but we to continuing that it the we're

out, so now good And has resumed. the the news manufacturing is, he's

very working validated dedicated yes, with that the have, addressing in working specifications, us entities in hard. team Both the and sure in they on very is are And alignment CMOs issues. the remain batches so and testing and of we're full with that those from CMO. And manufacturing fact, we meet The the the we doing process to conscientious make process.

that NDA we and cautiously have resubmit information So, all of respond to and to that, need we the optimistic FDA. the once we're

Jason Butler

for then this you terms or mentioned, payers that But had physicians, And any data just data Great. dialysis Matt, health you've on infections presented patients shared have or one catheters, and with this recently, economic feedback with the with burden in data feedback and you more the from positive of me. you of already payers providers? got

Matt David

think prepared folks spectrum we in Yes, that dialogue KOLs, give right, industry, we're and the Jason, specifics the have company the like. But before, to front. continuous with of I across mentioned is the on not payers, providers, as

to make work once for approved. as doing of So, part prepared we're the of sure that a it's DEFENCATH we're launch

Jason Butler

and the great. Okay, on progress. again, again congrats Thanks

Phoebe Mounts

Thank you, Jason.

Matt David

Jason. Thanks

Operator

comes question Securities. with Joon question. next with from Truist Our proceed Lee Please your

Unidentified Analyst

This Thank Joon. evening. on Good Les for is questions. for you my taking

prior resumption of? semi regarding Just like of resolved manufacture manufacturing new And guidelines qualification What that you deficiency. seems taken? you Has consists that And in or the your and FDA process vial this be regard? the does how for re-inspected long and -- plan also, to do typically has distribution? the in opinion to batches filling on the

Phoebe Mounts

I DEFENCATH demonstrate you FDA we're Les The What is that we should that and that it's doing questions. for for of the that vial thank you, testing qualified. during is currently filling requires fact involve the the clarify to process undertaking in manufacturing -- are that that activities process

So, it's manufacturing the in the a that doing requires actually process is there which a why we delay, ongoing when manufacturing. was had that's a validation activities, problem

we the part manufacturing new So, And to data that FDA. can continue the generating to of and the batches documentation are has submit that resumed, process. we that now need the

the batches and data manufacturing generate as we're batches to can go obviously, documentation. and those we collect So, analyzing

Unidentified Analyst

that Got resubmission, there? details is And delay kind of, payer has with lastly, provided have more and then strategy helpful. reimbursement -- it. the your That progress impacted FDA

Matt David

no, Yes, the I -- appreciate question. think I

no. unexpected what had answer today commercial gear everyone help continued short wanted team how side been we of abstracts know, for we they're doing the for have and and other with market all approval. that the highlight that Look, that and once on the the elucidated the we've using is as of really to the get you is forward. to Part think we've I is but delays

Unidentified Analyst

the outlook pricing helpful. data former kind on that's regards to you I Nuvi Great, presentations Just abstract more your strategy Maybe you. the How's forward? presented. that? gear one squeeze economic in just Thank your of can presented

Matt David

a into picture definitely costs the the great related appreciate. presented what can real was of talks you common on it's and these how morbidity as a to question no, it basis Look, big Part significant Well, about is and and I this feeds it just mortality how infection. imagine. and of

it. it about from to discussions system, in said until price into the We've that saved pharm of to we're the absolutely feeds always the going from we're pricing to DEFENCATH, to that prepared not the past cost that, the approval. closer beyond our will but economics are use So, stem talk that be

Unidentified Analyst

Thank you.

Operator

proceed Our of next line with & question with Needham from Company. question. your Bhasin comes Please Rohit

Rohit Bhasin

Thanks Hi, Rohit for on [indiscernible]. my this is for question. taking

Have being in issue the you talks there in Just across issues pricing of chain down see issues any been any shortages regards -- an to supply that heparin Board of terms or increases. possibly where any line? the

Matt David

None that? do that Phoebe, anything add you to to I'm aware. have

Phoebe Mounts

past, we shortages genesis have actually, reasons. the have question. as in experienced been aware you're for various There for heparin Yes, your the of probably in

very so been go have sure making have our we we adequate with of to activity. forward And inventory that conscientious

our So, that past. been covered. in and of sure concern an learned We've that we're lessons area making we're has the

Rohit Bhasin

Great. Thank you.

Operator

to to at Dan no Ferry I'd this for gentlemen, time, over further turn like are audio questions. call and written the questions. Ladies there pre-submitted

Dan Ferry

operator. Thanks

consultants question they release? to recent discuss CorMedix the Can you this resubmission first referred a with how assisting our is, process? are in press elaborate on and Okay, specialized company the

Phoebe Mounts

Thanks for question. that

addressing good pre-approval team have to to specialists, and the a facility, manufacturing of inspections. possible, we have and assist expectations preparations we engaged done have the specific it's question. Obviously, for FDA's additional think for activities deficiencies everything in the of of quickly consultants at because these as a I the but expertise to need on external provide CorMedix importance the as

activities. comprehensive for sure we and what make of resources looking and sufficient to of that had to will were all knowledge be being sure we make complete wanted FDA adequate our we So, in that

Dan Ferry

an focused thank Phoebe. CMO? Okay, Has securing additional on company you, the

Phoebe Mounts

the of pursue manufacturing additional CorMedix Yes, United identification States. continues as past, in the capacity we in the discussed to have

we have in that process continuing announce contracts detail to are when We and intend hand. finalized we

Dan Ferry

you. Okay. Thank

example, Next CorMedix's for potential pediatrics, is what oncology? for indications TTM, is question DEFENCATH, plan other regarding

Matt David

No, our Thanks DEFENCATH for The quality technology. as in think I company additional and remains and problem. uses to, potential indications no pursuing I Dan. interested, alluded for

have program clinical said post-approval to a on basis trial pursue aim would We a with in emphasis we that past on an safety. the

Dan Ferry

great. Okay, Thanks Matt.

Next current contemplated question is in commercial launch your are cash guidance? activities

Matt David

I'll Yes, that one take as well.

As includes cash the we've guidance for of described spending launch. stages initial

Dan Ferry

great. to there Okay, at CorMedix? headcount been changes Have any

Matt David

for have with one, too sure sure Thanks. keep moving Thanks forward highly talent been that Dan. Among have DEFENCATH. focused, and among relevant also our the stability areas team we the CorMedix, we we experienced making at to where things making that have

in In CorMedix the to those significant join from professionals highly interest team. seeing we're who changes seek addition seeing experienced headcount, also to

Dan Ferry

last Can Okay, here. question comment on pending great. litigation? you And the

Phoebe Mounts

on pending CorMedix comment contest you I cannot Thank the can we litigation, you. While that assure intends vigorously claim. to

Dan Ferry

closing remarks. I'd you for Okay, to call pass to the Matt, back great. like

Matt David

XX reducing the apparent of is and through in time you The CorMedix the various infections. experienced good out life-threatening Phoebe. Thanks importance during to evening. for of I of even successfully COVID DEFENCATH an Thanks the products ongoing from of and Dan registered the keeping incidence thank attention more launched clinical infections your the and have need protection taken the of patients pandemic. has a of market. hospital and pharmaceuticals market bringing U.S. help to patients CorMedix professionals to remains and committed U.S. phases team have who in studies

Operator

today's gentlemen, this Ladies conference. concludes and

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

CorMedix (CRMD) 10 Nov 212021 Q3 Earnings call transcript