CRMD - Earnings call transcript Q1 2021

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Operator

Good afternoon and welcome to the CorMedix First Quarter Earnings Conference Call. Today’s conference call is being recoded. There will be question-and-answer session at the end of today’s presentation and instruction on how to ask a question will be given at time. At this time, I would like to turn this conference call over to Mr. Daniel Ferry from LifeSci Advisors. ahead. go Please

begin. You may

Daniel Ferry

by Ms. and Operations; Officer; and and earnings and welcome Khoso first afternoon Nusbickel, Vice is Masson-Hurlburt, General Mr. Chief Counsel; Vice Chief and the Chief President President President Executive Matt Tom to call. Leading XXXX Dr. joined He and conference Executive CorMedix. is Commercial Executive Officer Vice quarter Phoebe David, the Mounts, Executive Vice Good of CorMedix Dr. President Financial call Liz Baluch, Clinical Officer. for Executive today

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

Khoso Baluch

stream reduced for call, us information XXXX Thank patients we its this on bringing making the On catheter-related quarter overall to DEFENCATH everyone, hemodialysis is indication a as use CorMedix financial thank first will for for you, U.S. Good infections. afternoon, first joining in catheter market discuss the for Dan. and you lock the and progress call. blood earnings through solution today’s

and are this morning. CorMedix call Joining Phoebe, on Matt, Nusbickel, joined this Tom Liz me who

side begin the on first. let’s people So

and in Tom several time Tom Pfizer and Amgen, Chief Tom space, Nusbickel, the morning. depth marketing, hemodialysis and Amgen, from As pleased brings Tom’s of operating expertise the at him this of time note experience already he U.S. commercial CorMedix government the Opco. Vice market team internationally. with experience both of have particular side experience the President will to at Commercial in his on the CorMedix where brings Officer. gained affairs commercial access Executive has Of years and augment that announced that I’m built. for joined a was as CorMedix

for are pleased refine We at Tom launch our plans. to CorMedix as have continue stage us this we to join important

Although company. will strategic share we started and on have this already his speed some Tom the for process to today it ongoing day, during first the thoughts. of Later is priorities up activities Tom’s the of Tom bringing call,

So label welcome, an update issue the of that that What a CorMedix bio. press the FDA volume withdrawn for Tom. included was that provided consistently that demonstrate can CRL On be we with process study of meeting protocol manual stated in an from extraction requiring there in press release release is our control to the in agreed-upon identified April us the an that FDA. XXth, confirmation

operation In of manufacturing the qualification and the at data on the additional addition, operating manufacturing filling FDA’s facility the concern may generation third-party addressing process necessitate of the of parameters regarding DEFENCATH. for adjustments in

identified progress deficiencies has addressing manufacturing third-party During on Phoebe FDA update this will the a you the made call, provide an by as CorMedix facility. of today

patients, an clinical bring initiating DEFENCATH with and of to What TPN medical the In approved. group are the the once Liz regulatory approved DEFENCATH and using line study for use required to has DEFENCATH the required work provide CorMedix enter NDA group the caster FDA a of label the finish doing progress team groundwork work effort to prepare a update the for hemodialysis expansion into expansion oncology the label conjunction patients in for continued when indication making in addition the venous initial the has been central for use. for for to is by would across

sheet. have financially, with Matt the CorMedix’s proceeding resources our the quarter provide that required provide the of limiting balance are one XXXX will regarding update color while to you our an U.S. DEFENCATH we bring so We to financials strength and cash these successfully patients in plans of burn

introduction move first let’s of Tom topic, the Tom. the now Nusbickel. to So to

Thomas Nusbickel

Thank for clinical and at infections excited catheter DEFENCATH Khoso, the pivotal for solution novel, several CorMedix large the this company. potential addressing in introduction. you, is welcome time a with needs. kind to prevent The bloodstream lock I joining be significant the am catheter-related to economic markets, and warm

FDA quickly it possible receiving as company reducing approval. can who accelerating to DEFENCATH potential bring through its to failure in approaches patients hemodialysis kidney activities the a FDA patients with by will As DEFENCATH for be venous after hemodialysis central capital, able to approval CRBSIs as benefit from be

enable developing his where As strategies, relevant my in I I CorMedix space. spent in to community gained experience launching move the the build organization, commercial a to subsequent Company’s This introduction, significant the experience the closer in Khoso help had in hemodialysis the experience within career high-impact chronic products as first highly and will mentioned me disease nephrology and pharma launch in market. have my kidney including commercial industry, relationships leadership we and approval

team promise more with to realize clinical to team standard will become I’m the to As prepare join about objective firm DEFENCATH. by energized I patients. the built care the with this DEFENCATH, to extremely the am CorMedix the I’m impressed excited today oncology new CorMedix, be as My foundation commercial hemodialysis, has for lead the catheters. I patients, have works it to TPN opportunity, and as bring for using and venous we of to DEFENCATH learned central

hand it back me Let to Khoso.

Khoso Baluch

Thank you, Tom.

of press would the update, release Phoebe April XXth the starting from regulatory to Now FDA meeting. Phoebe. provide like after the I

Phoebe Mounts

deficiencies that report Khoso. by regulatory of during and Good pleased its the teams with DEFENCATH CorMedix you, manufacturing Thank afternoon, to I FDA review to facility the continuing work the our resolve to am are everyone. third-party NDA. collaboratively identified CMC

discussed, manual report that by FDA response sent pleased the can letter, in been I or previously labeled the the successfully. we to process to the DEFENCATH the of to that demonstrate CRL, be completed vials study extraction consistently As volume am from a study manufacturing controls. complete required withdrawn the confirm has CorMedix to

agreed-upon labeled The that CMC regulatory we efforts deficiencies now resolving contract and that data demonstrate action focus from the the or we to Khoso, had of vials. by post an teams volume letter. The noted meeting the application CorMedix our executed. manufacturer with clearly announced and withdrawal on consistent has to after CMO, continue the the FDA the protocol As been in

for identified and of explained needed and our have will previously, the address on on of the analysis, the of we major on and CorMedix with for qualification by have additional process manufacture generation data that be to DEFENCATH. deficiencies operating the been process we Based need in FDA. FDA’s concluded evaluating As validation manufacturing parameters subsequent operation have adjustments concerns additional was to filling the focus of assess CMO the available data the qualification

At resubmit result, in the the be As line our meeting corrective in fourth FDA plan received. during facility at to if deficiencies on-site that cycle, of be when time will NDA current defend NDA to complete cap an to stated the determines an of determined XXXX. with would corrections FDA is do mid-April, the be next that the resubmission it time the may FDA so review the evaluation. also all a review be actions expects FDA is to evaluation able resubmission the all verified on-site in quarter

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

have pandemic. on-site because the explained it a from in the to on deficiencies review ongoing on place requested based There I of was As CMO. inspection COVID-XX due identified FDA records call, restrictions travel previous the that of a no

will the manufacturing for possible. of to approve NDA quickly reducing medical review approach life-threatening, bloodstream an the are infections of facility continue We the FDA to complete recognize potential review unmet as as the and to that need address hopeful using catheter-related record the DEFENCATH,

application. has guidance CMO option a However, that a will help approved; FDA document be can be NDA frames the is facility that current inspection interactive when the before inspection FDA, interactive FDA’s normal whether is in perform operate hosted we assess decide when can remote the gratified an should conduct remote by the to use assess for of conformance Virtual a it the required marketing scheduled the remote now spite agency within appropriate practice interactions the good are will a pandemic. COVID-XX if to the time operations of requirements. and that platforms inspection recently pre-approval facility is evaluation. equipment of evaluation DEFENCATH by in evaluations decides will The with In the expects manufacturing interactive the it a to FDA released agency use operational. IT manufacturing preapproval manufacturing

activities clinical providing are to As we updates I Thank update you. deficiencies. the stated, at of will Liz Liz. as have resolution the CorMedix. we we for committed an through consistently on call And turn to move now

Elizabeth Masson-Hurlburt

Good Phoebe. afternoon, the team excited you, Thank activities to it efforts by of the clinical DEFENCATH. and as recent everyone. I’m relates

as receiving come opportunities nonfunctioning versatility while DEFENCATH, pediatric patients critical. Given of to patients care that for very pediatric researching population hemodialysis expansions and the expanding there explore move young to subgroup market. we access, in blood catheter are a in the hemodialysis profiles experienced given a or the we health an for potential vascular to Similar a well primary dialysis catheter the standard LOCK-IT-XXX. To CBC. of unmet the congenital live, start, the inherent than the patients In challenges, patient potentially and adult, we common as in adult kidney. have using glomera patency need. And and the for These hemodialysis of causes on Furthermore, a studied infections often patients have long-term the stream and specifically small remain able patients of care fistula patients been of patients clotting. kidneys filters most is or to pediatric via are differently are defects, scarring maintaining children, like complications these label catheter the

patients medical outpatient support We and in hospital-based centers have conversations are with pediatric to for leaders DEFENCATH. a hemodialysis in academic the feasibility that the These in-depth institutions many significant centers numerous from pediatric serving pediatric are with on hemodialysis interviews program renal Based The often with our develop key involvement had thought gain house affiliated treating pediatric space. often esteemed experts questionnaires. physicians. and

upon protocol XX younger pediatric the that sizes. old of submitted clinical CorMedix developed pediatric to into have contingent than FDA this catheter include This robust a protocol is study awaiting is to and use DEFENCATH patients. the years approval. with patients designed expands varying We NDA review,

vascular These access are As we The those patients the team. treatment vulnerable depend populations, their greatly a discussed, properties protective and the to catheters TPN. previously for patient’s patients chemotherapy nutrients. priority receiving total parenteral to on is a beneficial and to potentially of DEFENCATH including or undergoing medicines number those antimicrobial deliver nutrition patient life-saving protect need

of the the literature interviews with in not conducted has also CorMedix maintain the the and the medical past continuum but reduce care of is the infection and care. threat to CRBSI in-depth CRBSI catheter providers of assess need ongoing published the access management of of month, on patients It across frontline Over a clear to team clinical high. number occurrence these needs based understand remains groups, health only that to these

care million number For unmet area. the protocols XX type the and leave significant an to a will infection Cancer we patients chemotherapy year stage XXXX, the And cases expanding and in of call medical financial we these populations treatment our in by due patient so to there of appropriately confident to evolving are TPN specific approximately per can be priority. in Matt. forward the system place Thank States alarming from protecting I and Regardless to diagnosis can their that rate paradigm or provide reduction vulnerable to design look guidance. to have Matt remains now United that that Because catheters regimens treatment is we and immunosuppressants, knowledge heard a the significant with patients, patients. medical of turn XXXX. that in cancer We need to XX you. to new it patient the more health cash this CRBSIs. DEFENCATH has, million support a these over clinicians disease to grow oncology cover in compared expected align continue other a in results is need just at will

Matthew David

in to $X.X decrease driven LOCK-IT-XXX million, first to by and SG&A report expenses our increases additional XXXX. has information XXXX personnel versus to compared in higher for on the of to pleased the report discussion stock increase company activity a a clinical trial. hires. quarter XXXX preparations you of I’m due driven SG&A for to by our approximately used manufacturing in DEFENCATH overview research net urge to for update related XXXX. related the to of staffing million first of commercial in for the loss $X.X accrued approval the an million in primarily XXXX The launch. expenses. was first million primarily cash loss of first or in filed well per increased decrease compensation, $X.XX period prepaid charges net X% $X.X the same R&D quarter of offset The in compensation, $X.X during cash was our of We quarter financial a by loss non-cash Form expenses Liz. the by primarily first decrease increased $X.XX loss, of in I recognized as non-cash in approximately compensation, increase financing stock quarter used its approximately costs offset With and here and by results potential with with to due closing a for XXXX million $X.X first in XXXX. the We XXXX. DEFENCATH share, an expense quarter read quarter complete compared the $X recorded quarter as charges was $X.X today increases net the a well higher This of quarter and XXXX results. in trial the net XX, expenses in you, in first quarter to non-cash XX% results, in in of more operations in expenses the expenses share to $X.X XXXX. XX-Q compared $X.X increased increases with included smaller preparation in compared expense net per ended larger our March as and of million million The in expenses respect driven of costs costs contained financial the of Thank or financial for to operations Operating approximately be first provide increase as R&D recent increased both million on cash increased XXXX. XX% million compared recorded by an market position. with our with higher first XXXX

the this have our the of discussed believe and XXXX. We As DEFENCATH gives second XXXX. resolve least to a that March the million CorMedix $XX.X balance CorMedix at half year-end flexibility on we resubmit for prepare bringing earnings DEFENCATH identified, is and call, manufacturing in sheet NDA, company from to a perspective. into of as have strong XX, market efficiencies cash company equivalents The to take position continue of been the has

through support remain we value investors. With and strengthen Khoso. We DEFENCATH’s to community to I manufacturing While investor as would are of we raise regarding conferences the appreciate to we base the the floor among potential to that, continuing participants work in like proposition. CorMedix and investor the pass active our institutional identified shareholder issues, back look awareness the

Khoso Baluch

the solution the Thank goal DEFENCATH catheter, CRBSI market medical no anti of a represents urgently the manufacturing expansion in need. hemodialysis. summarize, with preparing and venous of the DEFENCATH drive the in connections U.S. successfully microbial patients a U.S., forward CRBSI. patients approved clinical would to of U.S. in by community which launch fronts: resolving hemodialysis for DEFENCATH FDA the very to our bringing study antimicrobial CorMedix an for on our be when approved prevention there as catheter for to you, solution beyond To central hemodialysis where with continue FDA; large in need XX% protocols expand the DEFENCATH continuing pharmacological is Today, focus experience our on label unmet occur effort X by to is for Matt. deaths catalog Where expeditiously first to significant ROC continue prepare approved cap agent third-party segment, many CorMedix hemodialysis market the deficiency, we and as the

a That to remain manner. We will in DEFENCATH identified third-party appropriate the U.S. resources place manufacturing been the study deficiency. the start to confident resolve and that team to in post-approval and timely able the So bring be setting, we this we a in patients in have hemodialysis that have right

let moderator. of We expect throughout Thank you to back continued continue Operator. to support your the call now to Laura, updates process. provide hand this And the CorMedix. for me

Operator

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

Jason Butler

the Congrats quarter. on progress the in

study, one, extraction the the with analysis First agreed results within with just FDA, FDA that plan? And a SAP from that agree just on manual protocol within what vial guidelines on could consistency? fill the the has the study fall you statistical that agreed and confirm you for did you you typical

Khoso Baluch

Thank Jason, question. for you, your Phoebe?

Phoebe Mounts

Yes. We the FDA as completing that you successful can were required. in assure we study

Jason Butler

then in time agreed And you And us hear. the plan is already granularity to give needs terms great to process what is CMO you to of And in terms with any be that is there? lines done? in qualification there of have That Great. your work? can work, Okay. the additional what complete

Phoebe Mounts

Yes, the to forward agreed we and generate additional with resolve plan on go by the the the data FDA. deficiencies required have to CMO

the be has the required requested we will request additional have fulfill said, we data the agency. controls As on as and validation the qualification. to a batches to the manufacture focused of And that, some result the has process on FDA from in-process

Jason Butler

marketing just Tom, to you focusing key launch the key me. of maybe are now X congrats highlight what going that ahead for launch? the and be your Could of drive appointment. then attributes think the will And on you message on the are for DEFENCATH last Okay. Great. activities some of your you

Khoso Baluch

that today’s you have Tom’s So work day, first on to dig beginning we Jason, done far. so are know, as we the

is Tom and through so beginning in is And got have go what still to what we place missing.

plan his he of be hemodialysis the bit of maybe I I and has in from we think the get introduction in you Tom’s doing. But a particularly Tom. more years experience, involved into side. the So been that of little before share is is game would give he time would Tom a what space the he with can to good what what over details

Thomas Nusbickel

Sure. Thank you, Khoso. Yes.

disease in in Sensipar, of and peak in to to dialysis provide As at best Khoso with access global strong for I for then superior on and CMS over to adding to XXXX, closely element burden dialysis to its A the the SHPT value changing community Axis unmet when and key standard led secondary Sensipar hyperparathyroidism which Sensipar were XXXX. Sensipar success Amgen, work physician global ESRD protect the $X.X develop Ultimately, sales. in communication patient launch strategy, focused the the need choice achieved first outcomes the and was were I that strategies growing proposed proposed high with was and billion Then policy in of bundle care. not Medicare the mentioned, versus CMS’ the community oral Sensipar therapies. to ESRD for successful SHPT drugs added bundle the in

including In with (Ph). renal Epogen, most and Retacrit [RAYALDEE] recently, addition with therapeutics, also Parsabiv, to other I my work RNS, worked have Sensipar, closely

Jason Butler

Great.

Okay. on the Appreciate it. helpful. That Congrats progress. is

Operator

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

Leszek Sulewski

Yes. This Les Joon. on for is

next the FDA you review place? on First the in would the response resubmission cycle the expect assuming from of you take and the to quarter, when would when fourth expect - NDA

Phoebe Mounts

that clearly an time was for them. That clear very meeting determined had mid-April that the that classification determined in issue resubmission time line that when of with at the was would we the review NDA. with also we the the be would And at discussed be of FDA FDA time.

no time information line. on the review at this time have we So

Leszek Sulewski

you perhaps new Okay. FDA if on this regarding at this with stage? virtual had a and that that virtual And then handicap towards necessary you provided the FDA guidance the I visit, discussions Have regarding do inspections. understand.

Phoebe Mounts

did FDA not with after them. with guidance came out bring and when that No, we up it document we met met FDA

to it evaluation cannot interaction. states manufacturing I guidance document, remote is request appropriate have and is the that the facility read remote guidance it will you think the clear a if FDA the interactive when decide

on-site obviously to address of the part will it for done do be is been interactive if review using addressed or evaluation that the verify the it work And the evaluation. completion remote program decide, one, an to deficiencies. whether and the can process, the needs not the of FDA assess as So to

Leszek Sulewski

In hemodialysis there helpful. later on is then regards have would of in be to the pediatric patients, then to a study And That and last for one. the CMO? patients re-approval

Khoso Baluch

question. Good Phoebe.

Phoebe Mounts

I think you the are post-approval the study asking pediatric CMO do to hemodialysis reapproved? to need be would

Leszek Sulewski

moves that then assuming Yes, and the forward in future. improved

Phoebe Mounts

a expansion label supplement filed will The be to the as NDA.

point, that manufacturing facility inspection program at FDA. the So would be on a by routine

Operator

comes question Needham next Company. of with Messer Our & Chad from the line

Chad Messer

the Great. which And all on call and most I from and But regulatory do on investors appreciate Phoebe for details this and this. necessarily the company I people especially I other experts probably for apologize I’m imagine not being given. some of the own can’t things, my have but to alone interpret to trying able details in and deficiency you notes guys any in I follow

you FDA. can a that But me get say I ignored you easy a maybe And is walk although uncertainties timeline in it. manufacturing, to quarter need that you just later with you from as maybe through not beforehand NDA. these. were validation much So you the can. I think I These of to the there questions, you FDA, the to need it, not or and far through that and have as When you these additional you I lot breadth maybe which sapped you deal the me an you like I’m too are maybe talking achieve NDA address I’m truth. all can on, little the submit through fourth that isn’t hoping of of extra just and this things, about And some with submission? smart, to think need me on steps by XQ bit bunch treat are then slowly, got What qualification have processes a

Phoebe Mounts

is as Okay. No of as highly a they process side CMC is work, an working very is and experienced the And can a it side. and No these It one, equipment. like precision is both when that on regulatory with simple, That and be subject issues is well all it complicated needs not teams why individual wrong. in something to is and expert are areas. we conducted have go to apologize. this, the to technical need all sophisticated

times the procedure during are loaded kept. into results a controlled the And data operation, us process so unexpected obtained. and process vials good and to concern by they generate sterile is consistent which a are is with the expect filling to that, be focused may is during our FDA’s vials manufacturing when on express there DEFENCATH there them which requirements us meetings that the then for to the They is practice. demonstrate agency’s with sufficient as process

So part is manufacturing during but run. is of a DEFENCATH right vials also the clearly, making the in that of process, very sterility sure vials. loaded important of are into volume accuracy thousands the And we talking the about

in its process very is a make means the a intended qualified lot complicated to has I involves involved it intended been for which has the has that that step equipment the sure as said, is qualified, the of is the data technically as that and using a jargon generation product to specifications. meet and it been And all to itself So qualified. of the every use works manufacturing process everything produce and process

So well required for they that are very detailed as on a basis performance on requirements a product. basis the chemical is

needs And required to facility that reducibly manufacturer very generate the is process And can robust, so process the commercial the that for the distribution. reproducible. do needs and be product be demonstrate to to on burden that

Chad Messer

taking has to appreciate back me I clearer in that. was been Well, than That Alright. to it you the past.

Phoebe Mounts

Certainly.

Operator

call to back I turn for over this to There are no questions. written phone. Dan further would Mr. over questions like the Ferry

Daniel Ferry

some have Khoso, rising Thank Operator. we here. you, questions

Why you a time? First CCO on point one have bring at is decided for this you. in to

Khoso Baluch

Thanks, Dan.

a plan Commercial in along to Chief place to was DEFENCATH. Our the all launch Officer of have prior

in where to the when hired and a candidate U.S. the continued a potential forward preparation with us Tom join our DEFENCATH we approval. NDA to continue the we at now plans in And path therefore, the launch are and We point confident for our are of market. right comes across,

Daniel Ferry

Matt. Okay. is Excellent. for David, question next Matt here The

As the down, we for cash burn do your how must guidance? How resubmission cash how longer CMO, long? no. contemplated is affecting progress; this the continues and regulatory come your about burn current think with we wait for your activity this theme in The

Matthew David

the Thanks question, Dan. for

guidance. current factored our into work have and manufacturing the resubmission cash process We in

into described, to As resources needed take the least half we are have us XXXX. second that have we confident we of at the

Daniel Ferry

have here what is described Okay. Liz. And question is timing that the remarks? these additional final beginning Excellent. studies the for the you Liz, on in prepared

Elizabeth Masson-Hurlburt

Sure.

them we forward looking as after approval. we receive are can starting soon NDA as to We

Daniel Ferry

Khoso, for Very would all floor over is to closing that Okay. turn the have. I good. remarks. I you to back like

Khoso Baluch

approval, to time coronavirus or bringing approved. you, not team for in of strategic whether remains clinical need various market, good Thank more during this patients study, of to until CorMedix infections commence potential years in CorMedix U.S. marketing pharmaceuticals an Despite remain a through keep ongoing out-of-hospital from mind even attention, the onto partner life-threatening the you the NDA the the have delay your XX Dan. and taken of DEFENCATH incidence in and please pandemic. and NDA successfully apparent than for the committed DEFENCATH will or is executives products it keeping registration on Thank market. have evening. for with the infections. of more is because launched has own exclusivity that commercial our and The who experienced reducing of to patients importance protection U.S. a of help phases

Operator

This concludes conference. today’s

your your you your at time. the enjoy evening. this Thank and for participation lines disconnect may rest of You

CorMedix (CRMD) 13 May 212021 Q1 Earnings call transcript