CRMD - Earnings call transcript Q4 2020

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Operator

Greetings. Welcome to the CorMedix Fourth Quarter and Fiscal Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Instructions will be given at that time. reminder, is a recorded. As Instructions] this being conference [Operator to the Dan I turn over your will now call host Ferry. Please go ahead.

Dan Ferry

Vice Good conference call the year Chief Dr. Executive Officer. afternoon CorMedix fourth Phoebe by CorMedix. Counsel; and Vice of quarter Financial to Executive and He Mounts, and Executive is Matt Officer XXXX call. President is today earnings the Chief Leading Khoso Baluch, President and Dr. General welcome joined fiscal David, and

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

Khoso Baluch

overall year solution a today's the reduce hemodialysis everyone call. afternoon bringing US for we us XXXX this in and fiscal making catheter for indication its DEFENCATH use CorMedix quarter you lock as first earnings for fourth on thank and information, progress Good discuss bloodstream catheter-related to to financial Dan. you, for joining On will infections. patients the is Thank call, market and

In and Vice holders a Late with of year and added for David Wall President launch anticipated our as make drug level broaden July, CorMedix in CorMedix commercial of market Street company the where Officer; team, are capital, the CorMedix hires announced significant Matt FDA affairs other new to the the medical institutional XXXX and Joining our analysts. MD $XX banks company and me that on side CorMedix to our strides. Financial appointment including on help access this senior Matt. call the of NDA, the research million the relationship Executive a Phoebe to our announced acceptance DEFENCATH. application, prepare and the and DEFENCATH. summer, continued brought Chief was equity in new by financing for

time of Duncan. Amylin of Paulo patients CEO called a its Pharmaceuticals catalog U.S. successful February is also Pfizer brings of Paulo also FDA a and Prescription leadership XX, the as completion The the brings both which across its experience members. the Fee a infections, two well sector, used be review catheter-related fall AstraZeneca. and board to Costa areas, UCB. in new of granted and User candidates strategic the hemodialysis Chairman in Novartis and Greg Drug set as during for approval of through XXXX, BMS decades prevention for solution product of of added decades and demonstrated transactions to CRBSI. Our insight He sale the in of pharmaceutical President also this as NDA. In his strategic bloodstream PDUFA, leadership Corporation. at Act, Greg of range experience date commercial as therapeutic for review experience CorMedix as priority has

XXXX, we in more as with peers to into more transition we our of that is companies. rolled high better January said to we have CorMedix fit well as plan platform, biopharma As NASDAQ a growth the announced which

approve drug FDA facility and provided manufacturing form. weeks a that DEFENCATH present at FDA, by requested for new Drug FDA manufacturing the we its the and in of concerns the records Just facility. a review Food third-party noted ago, few the after announced by application cannot U.S. the Administration, the

of during contract further call X not both pandemic. FDA pleased not our news, All did manufacturing deficiencies pleased identified with we were the or March we that questions place were the during will the efficacy the by have organization, above the investors resolve outlined CMO, to the We And that FDA DEFENCATH. work FDA. with and we with took of safety the recent while the about any and the

is to Our have have the discuss provide with plan, updates. we the meeting we Once we and resolution as further meeting mid-April with plans will FDA with the the the a FDA. outlined, FDA,

be we in use Now hemodialysis meantime, efforts meeting the continue to to the third-party the studies start continue a CorMedix our setting those to post-approval and with second, CMO prepare the approved so connect manufacturing that in when resolve FDA; manner. time successfully first, the the clinical DEFENCATH expansions, able timely will preparing label with a community to the to DEFENCATH FDA; and fronts: with for thirdly, working focus study in protocols launch three deficiencies and by our to on we

preserving that financially, while successfully required the cash, bring We are with proceeding market. to we DEFENCATH to patients resources U.S. these so have in plans the

topic. X Phoebe? move regulatory provided. update Follow-up to first to we let's the the March Now

Phoebe Mounts

Thank have you, and line. we progress Good mid-April X Khoso. on FDA for start we a planned with March remains time the the I on with will afternoon, March meeting the based everyone. X track all-important made. line reiterated on The outlined time on in

each the a working resolutions of strong manufacturing been with proposed for of for deficiencies facility deficiencies. been the develop six by develop the responses We has identified the collaborative There third-party facility. have effort FDA to to our intensely manufacturing

the deficiencies. FDA protocol labeled outstanding FDA begin being with pleased to required request be the consistently product of Bio. the resolving that from to demonstrate I am to announce study developed manual the In addition, for to granted them the our that volume have by can drug withdrawn we has meet extraction

the As agency have of our we meeting previously is the proposed the agreement on adequacy of FDA stated, resolution plans the with for obtain purpose with of the to deficiencies.

FDA. manufacturing us join will the Our meeting contract organization with in

will an time will update line the on As and mid-April meeting resolution with deficiencies we FDA. we after planned, for our and provide in the the of meeting occur progress

conclude to commercial that that Our for operation manufacturing without an for goal inspection. the to is is facility ensure need ready support FDA the DEFENCATH onsite can

travel based explained I it of restrictions identified from an previous to deficiencies the of that of FDA CMO. inspection a agency. due The ongoing place records in COVID-XX inspections no As There at review travel in requested resulted was have had on ever-increasing the the pandemic. on restrictions on-site because have the calls, backlog

to hopeful review bloodstream potential the call for need back guidance. as records cash possible. And the complete I cover approve facility Matt? recognize DEFENCATH approach of and that as and you. catheter-related turn NDA now using the financial the will to to unmet an infections, results medical Thank reducing to to life-threatening, quickly We address the will are Matt, continue manufacturing the FDA review of

Matt David

XXXX. to trial in during million, year on higher hires. of by was our by $X.X, report expenses. expense research here financing XXXX an manufacturing-related company million overview research expenses was higher provide in am both to full XXXX. XX% quarter. primarily of fourth loss XXXX the quarter and million, costs lesser update XXXX financial to by contained launch. related approximately or fourth The recorded with results, fourth in to our costs our commercial SG&A driven we to decreased the $X.X quarter more XXXX $X.X driven $X.X and Phoebe. urge cash a higher $X.X SG&A costs recorded operations of clinical the increased million year XXXX This due million the market preparations of compares respect to for our million share extent XXXX. XX% of compared Operating preparation staffing of increase additional results. today share spend of to used by the million a fourth potential you in costs as for to the in recent XXXX R&D We in increased Thanks, for to filed due quarter fourth well a I expenses XXXX to compared $X.X approximately of just in due has report expense in of DEFENCATH With XX-K the decreased increased quarter compared full $X.X its in related preparation to compared results. $X.X DEFENCATH's in read Form as recorded financial pleased cash net activity. primarily for net quarter fewer expenses to XX% XXXX. financial with We of with was on of fourth in and and of as increases in per respect discussion to well or as XX, R&D $X.XX With The financial quarter be December to approval. year market per $X.X increases information loss recognized This by results. SG&A, operating used the and net approval fourth approximately the for on our ended approximately of an with increased quarter for operations fourth results, expenses with net quarter XXXX. I loss to million the $X.XX the the potential quarter our related driven fourth complete

compared by well Our XXXX. was $X.X million increased expensed, XXXX The as increased with XX% in expenses XX% increased hires, by to increased net Operating R&D LOCK-IT-XXX net increased approximately higher to deemed as compared with material XXXX costs. driven trial. additional million net was was $XX.X $XX.X for XXXX as be approximately XXXX by costs research to XX% loss staffing primarily to the $X.XX expense G&A approximately increase with with in recognized $XX share dividends closing reduction expenses costs million or raw as per in XXXX. in or to XXXX. due costs in for of a to $XX.X related $XX.X clinical offset in million per higher $XX.X due XXXX million R&D with trial the costs related increased million, higher approval potential compared the $X.XX compared related approximately by loss DEFENCATH. to a market of to to clinical million, due well was expense before to of in that compared This SG&A preparation recognition of purchases personnel costs, higher driven loss share had

issuance X March our of cash Inclusive end a investor defend the We gives prepare through cash following from million sheet have been believe we XXXX, $XX.X proceeds the CorMedix market perspective. company XX, strong is bringing and to million $XX.X described, least have in a and of has balance As cat of December XXXX. equivalents of call, the the of the our at million. CorMedix on ATM discussed position and that continue work from forma into XXXX, company $XX.X and pro flexibility year-end this manufacturing to issues to second of half for equivalents take

through conferences work among look potential to continuing pass and I base floor we the continue regarding value like active to shareholder are identified the participants diversify to With raise we manufacturing several proposition. as Khoso. intend investor While, community to also be the to issues, the CorMedix DEFENCATH in to upcoming investor we would that, back and awareness

Khoso Baluch

Thank you, Matt.

are me we represents three need. medical need Let Working determined market use with the U.S. deaths setting, that a hemodialysis total the the in to central post-approval can in we lock time I clinical to agent catheter FDA launch manner. approved and patients oncology should patients. manufacturing DefenCath and for be Hemodialysis DefenCath summarize, no to there care focus rapidly while the be become DefenCath the timely with would A solution XX% occur for community the DefenCath antimicrobial meeting pharmacological patients Today, start indications DefenCath the solution where nutrition that study significant preventing venous experiencing in to approved that and studies connect by so initially protocol in as the seek rock a deficiencies market, those remind preparing as to and catheter believe use be FDA; the of anti-microbial we the approved is standard CorMedix urgently central hemodialysis to a the catheters. in expansion are you continue approved venous many the to large it our segment will for the prepare parental FDA, when efforts second, the we on hemodialysis unmet that reminder fronts. where of very continuing with label thirdly, resolve CRBSI. by of US the on To CRBSI CMO catheters, successfully additional FDA; third-party focused in in U.S., a able by with first an in

lock with had of we the in and related bloodstream develop conclusion, the patients of DefenCath all a to identified DefenCath been have and as the total catheter post-approval regulatory working that infections basis. the this groups and oncology In patient We remain catheter previous on pathway these for reducing goal have with on in have the use the nutrition the in protocols that for clinical parental a the are FDA to team resolve discussions trial design third-party executing plans in solution the and additional bring hemodialysis to appropriate right confident deficiencies place and resources we manufacturing patients U.S. finalizing

over continued And We expect your to coming provide an update for floor post to the up you will weeks. of CorMedix. for operator Stacy? to the it with I open FDA the the questions. back support meeting this, Thank pass

Operator

Securities. a will first At Butler Instructions] Our question be this we conducting time, from JMP ahead. with session. question-and-answer Jason comes go Please [Operator

Jason Butler

taking for questions. Thanks Hi. the

any vial any First requested to FDA or by volume actually FDA Obviously, have flow one completed documentation the study meeting. you've with completed the air will by just asked the meeting, of said of wondering in take on the if protocols, alignment FDA gain goal meeting? is actually data on of you resolution plans. But either will to fill the you they new that meeting the visualization terms or studies to or any, for, have the the work

Khoso Baluch

Jason. you, Thank

Let me Phoebe. to pass the floor

Phoebe Mounts

for Jason. the you Thank question,

package put premature. to to if when together time them agency on know, request you you want meet it's the you the appropriate that for request don't and and to They you FDA, background have with information to a based a meeting with it's available. As justify grant

in So, developing proposed involved responses. obviously yes, the we were

sure to could, deficiency. information the -- that involve where we existing Some we And responsive we of we responses documentation. was that provided make those proposed

them new for there review there some responses. for So, of to the is information

Jason Butler

just clarification one And question on Great. there. -- complete then on more that the letter response

DEFENCATH? that that equipment relevant that there was questions to parts to mentioned equipment relevant still of are a DEFENCATH. not your the was couple view for Is You related it not of those to CRL

Phoebe Mounts

Yes, expansion new manufacturing DEFENCATH. equipment manufacturer yes. involved of installation new equipment. which Maybe, That at the was Jason, planned the is non-intended for facility, issue of

place manufacture. is for that equipment So, used the DEFENCATH in appropriate the is and has information been

Jason Butler

Okay, for settings. great. just or in for can And provide indications, scope Any additional at plans the use of last development me you this point on one of terms color the then you programs, need and could more potentially be you there added to other strategies development do indications X safety specifically, get those to efficacy or think Phase label? the studies rapid these additional

Khoso Baluch

Phoebe?

Phoebe Mounts

discussed can with to FDA anyone starts imagine, you As to trial. be that are issues need those before

make study sure the agency data. the on is way the you conduct to board You gather to want intend with and that the

them. time with appropriate we and to obviously the So, will talk at meet FDA

setting is approved in plan for post-approval to do patients. has Our use a NDA hemodialysis the it in after

in So, post-approval the setting effectiveness and of that not a a we're relatable venous focus central catheter would Phase doing catheter for and but reducing we patient populations, the infections expectation on to proper in be doing DEFENCATH be catheter-related should safety. be argue would the other a hemodialysis trial, X bloodstream would it that be we in patients and should use of

Jason Butler

great. taking Okay, for helpful. the Thanks questions. Very

Phoebe Mounts

you. You're welcome. Thank

Operator

Please Lee Next ahead. Joon with question, go Securities. Truist

Joon Lee

offer you issues wouldn't CMC as a Hi. taking a is I have Has they out And obvious as there? of our discuss make if some paper I good if and company? any curious a reached company? I remediable comments can are potential make Thanks as to the follow-up. for for have question. Just DEFENCATH on looks anyone it acquisition say an the mean if are, as the players you few.

Khoso Baluch

-- where Joon. forum discuss is This topic. the the clearly time we moment, market appropriate. that information Thanks that of Should any when be material, to and there where not is, at right update the would

Joon Lee

the third-party you deficiency address are working And that you of the manufacturer. enough. CMO fair to then with as mentioned closely Okay, the

was you why to what -- is What CMO's their you it you deficiencies, impression are contribute that do in deficiencies? addressing the that can to their issues? the it be involved so So, is need

Khoso Baluch

Phoebe? Thanks Joon.

Phoebe Mounts

a Joon. question. Thanks good That's

that don't parallel folks a understand think there's I process here.

over directly you As application. direct the and we drug have documentation that's information control to submitted new on noted, manufacturing,

documentation and process, of that ability part the facility that setting. manufacture reviews and in As commercial product manufacturing for FDA inspects a its facility the to

an the by the involves the also by records than facility the the whether reviewing training It in the it's and product but it NDA, and inspection on-site or broader goes to records equipment that. a the the personnel. to for manufacturing assessment So actual FDA, goes maintenance and inspection,

they intertwined is can't look because and So to separated, process, the it's obviously, potential the but the are parallel to that at be at manufacture the a product NDA. subject of FDA there facility for

Joon Lee

restrictions? case you. made And that Thanks whether XX to due for unlikely that that the to visit And a during still there this able be to the it. a questions at that the not? Thank with within will if And or question next various how in meeting is the is, determination occur quickly would you clarification. determination FDA share the the needed the meeting, as mid-April, with are the months will be last Street? Got be is site to

Khoso Baluch

Phoebe?

Phoebe Mounts

discussion it do one that's of continue that topics as that again, as meeting, like asked obviously, FDA to to And is that comments, inspections travel of discussion as this the GAO said, and for know noted, would assessment know that we'd And plan possibility. We’ll having facility. is not communication But a is it's and clear in that because when Obviously, you on-site CorMedix, the for an this my issue think of And but of remains a the of again, us we’ll said in and So, has FDA waiting manufacturing resolving will inspection. more FDA without for line determine companies the think is, for a I I FDA on-site then as if its inspection this it's doesn't industry-wide a And is the I not definitive that take give certainly a doubt answer, after for backlog the need implicit timing I between in place. available unique restrictions. there backlog. records the with to information that a the discussion that an stepped problem. I with FDA. and clear FDA there

get incumbent denied as possible, their And so, it’s lives. backlog think can the that out products through this figure to FDA so industry how to fast with upon aren't I save as that the and patients

Joon Lee

Got it.

Street you be able or I clarify, is could of and is to if the the FDA the the CMO? right that you the this it meeting, the to wasn't disclose one because which for that will it be waiting minutes, -- case the understood communication what is that take update share the I Which just weeks, be you contents Is the the between to a several So meeting able won't case will correctly. or after clear actually that the it? with

Phoebe Mounts

after with simple FDA. answer, meet a providing we be Joon. It's update We'll an

Joon Lee

you. Thank Okay.

Looking forward to the update.

Operator

Next question, Chad Messer Company. ahead. Please, with Needham go &

Chad Messer

we terms the may positive have to ideal Great. my a this you and getting share situation be additional ground lot nutrition do in outcome of timing, indications, like with expansion wondering, covered to in calls. question. might terms Thanks But back expectations parenteral of in details at information oncology into here. are what just that for potential label able in on of look for we us? assuming us taking previous looking what We’ve a And an

Khoso Baluch

think you I parts to question. got Chad, your So two

situation? the then about of first current what we able in of is will color The And timing part our label be are terms to expansion. provide

that update met can So working update have the we components we've with FDA FDA meeting right with that the got for and we what based let on now, our the and to plan assuming with after the we can the we've Phoebe on the alignment I But to finalize the add for outlined, the mid-April, we provide provide FDA we an resolution. add got the to Phoebe, the FDA as once NDA that then approved as And other clarity we've it. are on Street, we've sitting we the we start, be down protocol with like and me you to protocol. best into have hemodialysis, will got any said, will

provide the a will like. variety early outcomes. the different We because But market and it timing will the terms speculate, now another of study to of then in it's update what be too to what look can right

to wouldn't want the at I moment speculate. Phoebe? So

Phoebe Mounts

I think Thank you. you covered it.

Chad Messer

Okay. Great. Thank you.

Operator

Andrew question, Riley go B. Next D'Silva, Please & Company. ahead.

Andrew D'Silva

the taking that ability Good stuff? afternoon. market for meeting their questions. or more Are ones. them that factor you study? got with travel. few airflow a noticed actually Phoebe, macro of related in maybe curious, to pandemic you actually the there. activity Hi, a a travel don't I of fall lot extraction in noted the issues at Thanks to related my – was quick and just manual CRLs FDA to the that or related the CRL visualization those to relate study under of the to really I aspect also items look does is

Phoebe Mounts

there, Andy. issues the two mixed you've Well,

as of information airflow The from from the records first assessment. part to comes FDA dynamics the one, the provided facility manufacturing

And ordinarily in include to so, on-site the inspection. would added The extraction in an us. study the came CRL information manual they

response the we very deficiencies the were remember, in of because But CRL manual letter, facility. facility the the assessment information extraction in we to study manufacturing us what not that came directly the the to went records sorry. So for said on early quick manufacturing that was that the March – Xst, in letter aware were

not facility. is manufacturing was the that that assessment of involved the something in So

Andrew D'Silva

wasn’t a on the that, Am have I -- that deficiency CRO? So pandemic correctly? going if even still that warranted understanding theoretically, would would

Phoebe Mounts

That's answer something for you I question that FDA. can't to have you. ask

Andrew D'Silva

was distinction? if II II, this were And Class it's I with of not the had related submissions. remember is or this or this reading II I I at Class about Class or actually NDA I I is related, know or Okay. majority I curious efficacy definitely time a about then because Class your you we supplements remember following situation, if call, Class you non-efficacy when that's applicable an that, the last And talking something to do in be resubmission going if Class it's least in

Phoebe Mounts

a clearly process for The critical FDA. timing is this with that's topic discussion and a in issue

more insight we'll meeting hopefully, So have mid-April. after in the

Andrew D'Silva

Okay.

know for procedurally, if you its of outside don't outside So of category non-efficacy? this kind Class just a have and Class I but II own or –

Phoebe Mounts

worthy of FDA. It's discussion with

Andrew D'Silva

Okay. us working any not think first for let A the quarter? of Is Should model quarter we fourth me. know should then with the representation between activity, look And split the the you're on in about just and the couple or how years, it's like? couple would I OpEx quick commercialization first first bookkeeping. last question think quarter the since good in Can the second Thank quarter you what really the second quarter? last credit, you. over And been of tax the quarter. we that for first a

Khoso Baluch

Thanks, Andy. questions? Matt, would you take those two

Matt David

Sure. I'm happy to. Thanks, Andy, for the question.

that as a fourth reasonable guidance you you below think as I think we're guidance, the to in near quarter, can indicated a going target, forward, I come at I think least about assumption. that for reasonable look for giving Likely but the term. some first question your a but it's not for as

operating terms in of Okay, expenses.

the credit. to tax I question about second think on moving your

we the think that expect press the release that to quarter. second in I close in we stated

Andrew D'Silva

Okay. Perfect. forward and well. as Thank going good you the of luck luck color. for meeting Best the in

Khoso Baluch

Thank you.

Matt David

Thanks, Andy.

Phoebe Mounts

you. Thank

Operator

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

Dan Ferry

Any fix one directed to you operator. hires have any at needed changes Thanks, to Khoso. the the management additional expecting additional least It current Khoso. situation? team? Are have we here. question or the some you, is to from Khoso, Thanks, we audience

Khoso Baluch

I with working during the current CorMedix the to team prepared submitted management develop very to do said the for situation. need see Thanks, be is additions Dan. CMO remarks, is experienced. The our changes needed to the And not or address as the any management to information to team in FDA. I've conjunction

the we're that very the have So, they experience and with team confident got.

expected. So, additions planned or are no

Dan Ferry

you, closing I'll Khoso. back you remarks. for turn Okay. over to Thank it

Khoso Baluch

the Thank various U.S. are executives, launched you, we that some team just phases registration has Dan. CorMedix and closing clinical the in and on of of an That my studies, touches of products question, successfully who through taking experienced remarks, market. which of pharmaceuticals had is sort

pandemic. to CorMedix patients with stated of market, own patients to our of bring help the keeping of infections U.S. importance this ongoing out infections. partner we've to previously, As or need in reducing apparent commercial the on strategic or committed more The a DefenCath in during remains even incidence from coronavirus and protecting hospitals life treating whether of

So, thank have your evening. good you once and again time and attention, a for

Operator

This concludes today's conference.

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

CorMedix (CRMD) 30 Mar 212020 Q4 Earnings call transcript