CRMD - Earnings call transcript Q4 2021

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Operator

Good afternoon, and welcome to the CorMedix's Fourth Quarter Earnings Conference Call. Today's call is being recorded. There will be a question-and-answer session at the end of today's presentation and instructions on how to ask a question will be given at that time. I would now like to turn the conference over to Daniel Ferry from LifeSci Advisors. Please go ahead.

Daniel Ferry

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

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

Matt David

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

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

manufacturer FDA in or discussion had CMO, CorMedix conjunction reach front Yesterday, Let's NDA tirelessly the third-party begin with contract we to resubmitted Phoebe, that Phoebe our the FDA DefenCath filing on we details CMO facility our action and identified in for manufacturing update. to FDA manufacturing to with team, with by for review regulatory here by in pleased the letter that last On order that the CorMedix. has issued announced responses CorMedix the post-application progress at today. the submitting concurrently the the since the milestone deficiencies The to topics our NDA XXXX. the with important XX, in were share begun to in worked and the resubmission February parallel is accepted for provide led our the on very process. CRL

run towards has globally appointed course responsible strategy Joe across chart launch, forward the has business Chief million Most me years $XXX commercial that commercial a before Todisco Executive areas. XX. business and XXX as and of where multiple CorMedix approval or continue for and and in leading brings announced to we with working Everyone CorMedix as experience recently was at therapeutic As and to roughly recently, significant a Commercial and Joe Joe business, spent organization when May joins organizations the potential growing served our Joe, on welcoming operations, DefenCath look XX employees. building we Board joins he Chief him Amneal's last with rate managing to in Specialty leadership the Officer Officer. he

to FDA in for that launching the anticipated we We our burn cash DefenCath an DefenCath financially, U.S., bring while approval. the so to balance preparations continued following to have efficiently resources have our limiting patients

a financials and I in our and fourth resubmission expect as full-year spend ramp cash potential position. activities quarters quarter provide XXXX see With manufacturing to the in being provide we now increases pre-commercial launch. on planning activities will update and our color regarding NDA some we the an coming reviewed, and for

medical discussed some were the During population patients an team to team approval. we last of provide via the bring of to abstracts completed commercial color The in call some prepare conferences. hemodialysis is as CorMedix by that and industry the affairs today work November, at infections FDA continuing that we following earnings had to bloodstream the in our topic catheter-related to our team work on presented magnitude highlight patient DefenCath

research work we a factor are considerations and we reimbursement care; hemodialysis team, will that opportunity of leaders two, pharmacoeconomic our continue the each commercial for dynamics; While of, firms thought market spectrum understanding to modest-sized this three, as and our consultants, the into one, DefenCath. market across expand leverages strategy important

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

Phoebe Mounts

bloodstream report Thank you, I with Osterio], for accepted Matt, NDA to my and would FDA appreciation pleased Amaru the very work gratitude filings. have to team has [Ray FDA Sanchez, hard move whose like and work DefenCath dedicated step in with reducing Jessica to to life-threatening able closer Vaughn to expertise for express able and Sibu Varghese good individuals resubmission and CorMedix resubmission patients. my to afternoon, to I am enabled being a of everyone. infections catheter-related be approval the that and start DefenCath

letter. had at In identified for with completeness informed concurrently the FDA we we post-application filing, resubmitted policies essentially considered manufacturing is In Class procedures previously manufacturer contract data II by Class a deficiencies to previously reanalysis and of of the with not the NDA a the month, is Class nine CRL. minor data the response company's letter FDA's the II accepting manufacturer resubmission such by cycle. to submitted Letter, provided in reviews or specified manufacturing FDA is we the new late complete II last includes and has submitted. data not the issued filing worked CRL. made believe and resubmission review as an FDA for action been items, the therefore the to a decision. the with a list and in and has As that six-month resubmission FDA DefenCath NDA resubmission FDA explicit I resubmission the believe the defined any as as requested which DefenCath for address The collaboratively a considered CorMedix third-party that Class facility item parallel, announced action resubmission item, Complete Response that it

the previously we of that facility. FDA of a inspection stated may pre-approval As require manufacturing the discussed, deficiencies had resolution had

the from inspection. FDA by FDA committed pre-approval working begun We our and of that to the ensure have successful review which FDA have respond to promptly the requests period. a evaluation We the FDA information, partner NDA, notified by to adequately have and within jointly complete that believe its has six-month concerns inspection an we FDA's ensure conduct inspections. remain will believe additional been of will manufacturer timely the to continue NDA. has We for identified learned will we it addressed the to CorMedix already the begun review that that FDA, manufacturing already and

manufacturing the to the to commercial is continue you approval asked data had reminder, CorMedix operation information demonstrate secure that study. clinical a to FDA As the DefenCath will not LOCK-IT-XXX to and relating diligently resubmit to ready working NDA. from DefenCath FDA of for I to can that assure any we support been facility

updates to over to capacity manufacturing activities to during months to now investors secured the adequate like directed I that has turn use committed would unmet process. CorMedix a following expand to are to for providing is towards clinical appropriate We our in ensuring the CorMedix as indications review of DefenCath coming the infections. of trials planning position be the meet for bloodstream approval reducing to medical need DefenCath. for an catheter-related FDA anticipated

previously adequate additional and is United discussed, CorMedix in the it authorization inventory. are potential manufacturers FDA. of marketing in believe from sources States, also challenges in provide multiple identifying supply chain to to as ensure potential obtain anticipate are We to has we engaged important we place work Accordingly, while DefenCath

I our to the Thank a discussions Matt? record being appropriate conducting will meet updates diligence turn anticipate We and of and potential financial available able Matt in manufacturing to are capacity complete results, ensure cover for expertise you. the cash our process We actively FDA And to the due appropriate DefenCath. to to track coming guidance engaged in manufacturers in process weeks. now diligence good and compliance, of commercial at technical back facilities call strategy the goals. with

Matt David

Thanks, Phoebe.

including our has XXXX. full-year December million has proceeds cash approximately our complete for of urge you XXXX, equivalents the Next, has and XX, filed of cash in its for as of the I XX, company quarter financial December well and results. the overview fourth financial information position. of program short-term of CorMedix's first $XX.X With respect a CorMedix XX-K December company our ATM report an results, on the in in The read update will report quarter XXXX results an to discussion I quarter $XX.X to on from cash $X full-year financial forma and net fourth million. as pro investments more provide XXXX million our XXXX, XX, and of as the ended contained equivalents Form

loss charges prior million XXXX XX% $X.XX charges increased XX% to of fourth quarter studies for recognized stock-based in preparation consulting With to costs of Operating $X.X hires, in and of result the recorded DefenCath loss of in as market $X.X in $X.X compared net with by in marketing a fees an potential R&D approximately fees. and by was the or SG&A was research by increase an the the quarter quarter for $X.XX loss expense million increased extent, stock-based period $X.X XX% compensation. its net personnel non-cash to quarter our net to costs results. additional the expenses a for $X.X to prior the The partially potential for non-cash or fourth of increases in with of XXXX. an driven compensation. manufacturing SG&A million marketing offset million a increase increase approval XXXX. an in related approval decrease XXXX. compared and related expense to potential in same increase compared financial $X.X a share an fourth million share of increase fourth the of driven respect in increase increased DefenCath by and fourth non-cash consulting in expenses marketing an its compared the increase XXXX related costs of XXXX to the approval to with in manufacturing expenses. an Our million in increase with in driven XXXX quarter approximately compensation primarily approximately higher R&D in a of and decrease $X.X in per per in This to charges million, in stock-based approximately to full-year was We by lesser DefenCath and by

compared in in decreased $X.XX the manufacturing These its in approximately increases XXXX driven per XXXX. decreases million X% compared to by and in benefit million to driven Our and $XX.X $XX.X cash market consulting to by XX% the share potential $XX.X increase during with in expense $XX by in accounts personnel $XX.X The Operating preparation $XX used expenses well XXXX an half with consulting lower loss with to payable in potential used XXXX. G&A costs for clinical trial. in closing commercial FDA approval our increased related cash in increase compared fees million the to to loss, for We XXXX R&D decreases mainly with related in marketing clinical of trial DefenCath related our reduction the for perspective. good to costs forma launch $XX.X as decreases charges offset increases XXXX. received increase recognized The personnel net a in a company of consideration an the equivalents in compared expenses XXXX. approval offset with were after net studies a compensation SG&A $XX.X $XX.X costs XXXX. by was in expense increase non-cash $X.XX operations flexibility was first and expenses. and million LOCK-IT-XXX DefenCath the primarily stock-based higher approximately the increased approximately of versus for of a of for a as in $XX.X an by non-cash in XXXX charges for was compensation its in XXXX, stock-based million XXXX per initial same DefenCath. remain compared optimistic of offset into million XXXX, fees This sale marketing recorded or supply due in expenses, prior costs CorMedix net driven toward through taking in XXXX and partially from We related compared commercial was same operations our costs net partially attributable million in increase to loss approximately net smaller the in difference in stages million, from an by period XXXX. to approximately loss due X% million XXXX. tax of of to and by net DefenCath. of research cash in NOL in about believe the net the to We or in approval fund balance share period gives to remains cash million progress position and sheet operations potential to anticipated pro higher received

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

like factor of, that opportunity the by pharmacoeconomic last team care; continued dynamics; three, to efforts the market DefenCath with to consultants of continued our two, develop patients on firms would will considerations its across outside today, further bringing upon As has spectrum into topic the settings understanding market across views to highlight each reimbursement for expand market all I the the hemodialysis work hemodialysis to to of the care. research our approval. and CorMedix CorMedix and the one, commercial our strategy

treatment of constituents We catheter the rarely Changing a are setting times, hemodialysis maintenance setting. our bring following at treatment, the journey, our be CorMedix to the and our coordinated build all of and effort of central data the compelling without hemodialysis relationships quo education. spending in resources patient's landscape strategy including of without the to and in patients our The in around placement of team to and the chronic outpatient key and an on each order working the hemodialysis is prepared costs, understanding, DefenCath initiation and, around time status to the without of understanding key inpatient a its steps developing venous an comes approval.

strategies decision-makers inform CMS; to hospitals various and or On we of consortium Medicaid are with engaging broad such and around Medicare Dialysis National with for side, This providers; groups, and the Patient Citizens. Kidney dialysis Foundation a Centers reimbursement. of with as consultants includes patient Services, types DefenCath's CorMedix our groups, including and reimbursement advocacy interfacing working

pair and claims the work CorMedix XXXX in clinical catheter and a related that the of patients mortality and a economic incidence CRBSIs vascular presented related renal to medical since patients. and CMS significant venous The in at those undergoing was On multiple the affairs that that central underscored approximately retrospective these with costs of first databases to, of to providers care use especially from done as integrating recall access. findings and infections. highlighted hemodialysis conclusions side, XX% patient start fall conferences studies and quality are metrics disease These dialysis track important end-stage their of,

the the CRBSIs presence experience – the have secured We To the post-CVC to continue has our recent CorMedix is at hospital aim to patients had conferences share at we described mortality. expand spring, as clinical efforts and updates admissions, the launched the in submission approximately a will I XX% continue summarize inventory sufficient we'll our to leverage interim have is in filing resubmission pleased for relevant as U.S. commercial look efforts approval. sharing has also we we to for its course. to as updates today, lead we to enthusiastic aiming recent The the that on our a of further we significant much company CRBSIs morbidity the DefenCath and to in period, team review look and to following: strategy bring is the levels discussed focus this we more about the regarding FDA. the a first, NDA are CorMedix With able to that and that to to With manufacturing joining I contribute and be and we breadth data, on look do DefenCath reduce have on term. following prepare work ahead. insertion, of ensure and commitment The CRBSI team complex noted and the what more of forward in how to his focused to its patients highly cohort that by available announcements need the discussed Joe in CorMedix this update is longer to of stays to and recent six-month a There alternatives and of acceptance appropriate. patients significant the capacity Phoebe longer based

addition, carefully are once cash preparing NDA for we have by balancing In our while commercial burn the approval we of introduction of FDA. the DefenCath

in year to recognize over remain CorMedix team, benefit confident to the resources been continuing such venous and and Operator, We would As oncology. greater call to a to for shape our the team have detail we are the approval broader achievements approval many and opportunities CEO, moment of interest to a Also, parenteral in its forward DefenCath appropriate hemodialysis several in the future. continues understanding our to of place commercial spectrum months. to have our continuing care, for of strong continue take plan instrumental expand with central advance take for to hemodialysis the open incoming past support we across the and patients that whom questions. to following discussing broaden bring I to strategy DefenCath with to total continued please patients in catheters in of look the and we CorMedix. later your U.S. as this the like Thank potential in toward DefenCath you opportunity regulatory nutrition

Operator

from [Operator Securities. Butler JMP comes you. Please Jason question proceed. Thank with Our Instructions] first

Jason Butler

questions the congrats taking see. and great to for progress, Thanks on the Hi.

be have the the are things, on date? program? still PDUFA share under Matt, And yet? First a with then your planning And us? side reimbursement And PDUFA received Thanks. you date to based reimbursement the on FDA you would what that can from one, the of you timelines pursue TDAPA

Matt David

Thanks, Jason.

to on First Thanks. start. to Phoebe side, pass the I'll things PDUFA

Phoebe Mounts

Thanks, Matt. Jason. Thanks,

for are As the sets for goals, statutory timelines PDUFA, User FDA. I'm completion performance of goals sure review. FDA not Prescription Act, agency folks performance on And Drug and imposed those know goals most Fee or

given So of everyone planned during pandemic, is activities. the the everyone process the acutely of travel cognizant And unforeseen is develop may COVID-XX impact that can and aware issues of disruptions timeline. review that

cycle, are the given So to we prepared best. hoping work the we're for and for potential changes, review the within six-month

if updates be the significant will in So provide that that there we delays to will we're review hopeful are months six occur timeline, the review investors but of sufficient.

Matt David

other all in apply one which you I to Phoebe. the jump just talked evaluating know, I'll is alternatives, space. your We've believe the you the for timing which as of Yes, continue before, following TDAPA, is your on And we're think. but Thanks, was Jason, important question, products renal about an in, approval. that TDAPA route about an part

so takes, of the quarters. depending takes it to cycle, timing And two one it quarterly the on

Jason Butler

six-month it. that for And Or Got if gives that happen manufacturing that the me confident you scheduled? then confidence within that get inspection the Great. inspection six-month can you one that quoting said me, not FDA within exactly, forgive you but done what just already the I'm Is – second period? the a planned you were window. can inspection,

Matt David

Phoebe?

Phoebe Mounts

the scheduling inspection. from learned has reached about out FDA manufacturers them We’ve to that the

done ongoing, the get I'm on that months. confident in it based that we'll six discussions the So are

Jason Butler

one just last me. for then And Great. Okay.

data As interactions you Or any give just dialysis about the direct set? us more you work of building with through the you products the color commercial leading and providers? having any you're the how preparations, there awareness can are

Matt David

that we of expanding to Jason. team Thanks, on has been and research, a absolutely. our pharmacoeconomic that commercial prepare work payer CorMedix on, there's No, Yes. for understanding side. things doing really the opportunity The number launch. Yes, continuing the the through as DefenCath touched market of research is team

patient of catheter components and of from our the a visits inpatient initiation renal includes to for failure the a broadened of to have That venous central understanding placement patient. beyond. journey hemodialysis We all

And so recruit. we will begin to

and just that roles the at point. work groundwork commercial for really some this as potential launch, continuing we of I laying but key think we're some prepare of the on a

we'll gets a speed side, Joe and the I talk strategy. about more begins the up on think bit CorMedix really commercial little once to

get you'll in detail of the future. that So some

Jason Butler

the Okay, great. congrats and progress. Thanks again all again for on taking the questions

Matt David

Thanks, Jason.

Phoebe Mounts

Jason. Thanks,

Operator

next question Joon Lee Truist. Our Please with from proceed. is

Joon Lee

Hey, taking inspection to as happens, that believe has scheduled. deficiencies the question wording in was the related been our you press prior would a thanks that If that be disclosable the item, when consider for given CMO? release the I onsite well. and the to

Matt David

Phoebe?

Phoebe Mounts

the between That's and to manufacturer. that that not we're that CorMedix disclose. occur the That's conversations FDA willing information is

Joon Lee

Got joins that in it. the what what company, obligations to will be when the some current when fact, Todisco his be And curious has joining Mr. the know first be? is company? order going could And of timing employer, to just business? he actually his he but I

Matt David

the for question. Yes. No Yes. for Thanks problem. Joon. joining today, Thanks

strategy as And Joe start of to of today, and I'll go in him really, around join in said through expecting So tone priorities, XX. the to press is in and is kind or think very before, the our a I that terms of release orders on some May we've commercial let of believe with first there you, business get but perspective. setting from I certainly

have timeline, it submission excited relates we We've the share great that As the six-month and to acceptance we this some you cycle. today, got Phoebe, we right. were through to so news walked received review week as our that of a

to DefenCath bring figuring be making sure patients. really we four to and anticipated it is approval out are beyond, three, two, that one, to I prepared upon step going So that think

Joon Lee

burn first then through question. XXXX? in your guidance half of What's And last Great. assumed cash

Matt David

great it's No, question. a Sure.

guidance launch commercial the the said, the initial cash items as of and we for includes as commercial such So launch. stages supply

And so in that that. factors

as the that a half beginning launch. less the those the year, need you'll see, of company as in dial perspective I get think – of year the components will year, to each the to begin towards we rest as commercial think a you spend ready the what from of things about ramp really so but for second up is the up to of you

Joon Lee

All right. updates. to questions looking and the for the forward Thanks

Matt David

Thanks, Joon.

Operator

& Bhasin Company. Needham from question Our proceed. next with is Please Rohit

Rohit Bhasin

of for have question. Serge. you any Rohit of is taking us my Thanks you on can anything with discussions there in And had This pricing Hi. for terms payers? recent tell Is DefenCath?

Matt David

pricing, very thanks, think payer CMS, us and all obviously, for for for including the with Rohit, renal I thanks joining the significant and mentioned call, have we Sure. I the on time. payers, – No, discussions a Yes, space today. often during

ongoing. that's So

In we'll the the data that to hopefully, terms relates continue share DefenCath, work we pharmacoeconomic of year before, we dialogue specific more continue in space. this and payers pricing to with as described and it through the

So really of pricing a the we to plan around would discuss time potential approval.

Rohit Bhasin

Thank Great. you.

Operator

gentlemen, further for the Ferry will I and there call the no questions Ladies questions at back Daniel hand now audience. to this from are time.

Daniel Ferry

you, question Joe's mean Thank and first stay CFO operator. on Matt, CorMedix will on that our mid-May. Matt, you is does regarding joining responsibilities? focus in at

Matt David

as am a I look as Joe with Thanks. to Yes, past we six the these over continuing company question. accomplished planning what as for going have I Thanks the strategy forward am serve on months May working we I team XXXX. proud as and of to CorMedix' CFO, forward. guide have since

Daniel Ferry

Matt. Thanks,

you TPN, comment commercial here like pediatrics, indications on the additional And on Can one side plans Okay. for another oncology? of things.

Matt David

Sure.

plans discussed opportunities pursue the in calls. our these during expand broaden to We we've And continued use various understanding of of use the approval. DefenCath to detail in following patient groups catheters. past that CorMedix subsequent more discuss that an the to We'll to aim central have venous

Daniel Ferry

need in options the what will launch the on company? CorMedix sheet, And to available order money balance Matt, raise are And to DefenCath? to Excellent.

Matt David

a whoever has that Thanks, priority our funding CorMedix been sure accomplish the always question. to and make goals. for thanks strategic adequate to Dan, It has submitted

that stages to our commercial the we of access in through think As range mentioned, costs stage first commercial guidance to a the markets, launch. I other of the Despite similar cash half will related as companies. have the initial alternatives of includes XXXX a turbulence we

cetera. So et financing, debt, equity, convertible royalty

Daniel Ferry

closing you over Understood. to to Thanks, for turn back floor remarks. Matt. I'd the like

Matt David

your questions Thanks, and Dan, everyone, for support continued of and thanks, CorMedix. the

We to keeping in you share to life-threatening your and and a infections had need during patients bringing and able be been for have protection patients to The the to Thank are evening. of the COVID-XX with committed of to incidence from out market pleased reducing DefenCath infections. these more the pandemic. even U.S. you attention help remains ongoing of time updates today. CorMedix importance apparent the hospital of good

Operator

This you participation. concludes much today's conference. Thank your for very

You may disconnect. now

CorMedix (CRMD) 30 Mar 222021 Q4 Earnings call transcript