CRMD - Earnings call transcript Q2 2018

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Operator

Greetings, and welcome to CorMedix Second Quarter Corporate Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] I would now like to turn the conference over to your host Mr. Paul Arndt, Managing Director of LifeSci Advisors. Mr. you, Thank Arndt.

begin. You may

Paul Arndt

of Chief operator, the and Leading prepared Masson, And Executive Financial you, for Executive afternoon, open the call remarks, joined of we good and Vice Medical Chief second quarter Q&A. to Liz Paul call Officer Chief CorMedix Baluch, call. is, welcome He and XXXX is will Operations; Chew, Officer; today Officer. by Cook, Thank Khoso everyone. CorMedix. investor President Head the Bob Clinical conference After the up

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

Khoso Baluch

an financial Number to request Phase Number as where on for strategy the LOCK-IT-XXX the to next everyone, call wind afternoon, call two most on financial like us performance our The and XXXX activities. one, X completed bring driving critical U.S. will for on second the we you our down for quarter CorMedix. to we the for our on ultimately the rest to thank quarter our two, particular the two provide steps the year. update and Good and review of successful in the Neutrolin recently focus trial prepared the and Paul. XXXX agree you, the financial FDA value to joining update our today to outcomes of clinical analysis with with Neutrolin our Thank would areas interim meeting study to market the in activities you

with begin me the let first point. So

had about As of meeting you know interim timeline. the of LOCK-IT-XXX review from pleased July we study met to the today report subjects Board, for in I’m as to randomized analysis infection of Safety and stream double-blind, CRBSI safety previous therapy heparin renal make trial. using and stage Monitoring calls, Data care the scheduled endpoint its called we a end the demonstrate DSMB of catheter-related active results that to control is the hemodialysis the XXXX effectiveness Neutrolin The recommendations in Phase receiving the blood to standard multicenter, disease. treatment primary presenting X study in the as

previously remind interim to me As XX analysis was to when three place in of the designed you the FDA, take discussed occurred outcomes. events possible interim CRBSI analysis study. Allow with the

requirements demonstration predefined number the the unlikely efficacy to significant statistical results designed the Number its could as obtained. we CRBSI And XX continue due study of occurred. study First, events stop that due the because study endpoints. because the stop futility, efficacy, for the two, can until three, primary be study met to

unblinded the had at no and Neutrolin the announcement As X it recommended case the it Phase criteria was the LOCK-IT-XXX for cases met efficacy best analysis for an identified. which safety you interim for halted XX trial is as be the know concerns development. the trial this We in on uncommon outcome, study scenario independent thrilled CRBSI pre-defined data were and and occurrence were X based stopping July DSMB for from our our reviewed XX, clinical the from and Phase

of began study light with the clinical process seek an NDA single interim on given is accordance the activity taurolidine on and outcome the practice. might we we file terminating interim While of data for to trial Vice terminated. Head I’ve no believe were the enrollment Masson, we I to Liz. order clinical some to call In plan the LOCK-IT-XXX. agreement CorMedix’s the to achievement, on Operations and analysis trial with has color Based this occur positive the recommendation, of Neutrolin, the the we hand, taken. is join the Executive a a stopped to specific the FDA provide company In being details remarkable Liz President that that the good to you currently this while analysis available a The turn Clinical afternoon specifically is at and that task being achievement. asked to based DSMB’s introduced optimistic trial we provide over this body remained us insight of have for in to results will now ensure of steps blinded bias

Liz Masson

LOCK-IT-XXX Khoso. you, able required more details this to join on happy I’m Thank to call activities close be the the to study. and provide

an for study boards, review study institutional X. and thereafter focused XX, analysis we’ve be time. the now this subject notified orderly participating had ensuring IRBs are drug Certainly that team of July last The notified a interim termination positive We the the with which plan result. of by to on to our requires critical study, we work formulated of effort on dose August the when an sites during the the sites administer closely we

clinical numbers. a of interim letter analysis of site. including participating this a announcing for IRB enrollment base, of complete and able pivotal termination after voluntary their data sites the by for For number trial. will tiered were exposure is the The factors team drug. support the the done to currently positive team, they’ve return dose data approximately by monitoring cleaning the of final given of them The remaining been point participation study the the results to will study protocol the closure And rigorous XX approved have in data follow that our participants the into one safety the last subject all internal for early entered visit study study month site an be thanking once

cleaned we of prepared large our volume for on secondary emphasis analysis, and the As endpoint safety. team subject a heavy with the interim in primary data a

subjects of December that data those great enrolled early enrolled the XXXX. late December deal data plus for subject through a remains early through For all after the There with July. for subjects those

of I statistical performing. At activities point, back to completed process to hope of better data. group. we processes. anticipate remainder Additionally, BCI cleaning data and their in test and have transferred investigational for run, to cleaning helps this that that Khoso. appropriate processes as efficiencies we product I’ll and critical take sites this all bio to these checks the we’ve our We parallel I the turn outlined path management the over be the database be all the performed been the call edit to but the just regulatory locked are Once understand the administrative independent need XXXX in these will look in for complete, will continue to

Khoso Baluch

the Liz the Thank study. down you, to study required of site of termination. involvement And complete the the steps subjects and in the you’ve operational aspects What the Liz. are currently the from heard enrolled winding

Our regarding CRO us you to Chew, you will stage activities introduce who the Paul? perform interim for while Neutrolin now related we financial like continue cooperately of I negotiation to the through is analysis. completed certain our the to CorMedix next walk with working to Officer the program. considerations Paul Chief development would Medical

Paul Chew

U.S. on the Khoso. prevention medical to programs of development of in death. a the the significant closer application. going the investigational Thank just patients. DSMB DSMB of was we’re that This U.S. to to to as soon catheter-related and of product and trial development I’ll cause recommendation as possible an drug was significant even required sometimes information continuing outlined. potential the on Neutrolin the positive Based more stopped unmet provide must advancement in product you, hemodialysis enrollment bring us can analysis, as of hospitalizations details infections recommendation a be realizing forward. drug believe which has included needs. as closed healthcare Neutrolin new a in sell major A interim the as infections this Liz progress in the Neutrolin We can and underway to on lead out remaining activities the Neutrolin patients. moves Based orderly

what you wondering happened be now, happened Now what may many next. of

meeting and two support occur this to determine in that filing that these clear of which of from XXXX. development efficacy analysis NDA populations Neutrolin. the is focused package is path to studies program two in as and the a the on X FDA forward the will discuss has catheters. FDA, to Neutrolin’s the having patient central evidence for FDA what a in on requirements new for venous safety. Discussions terms terms of Phase to in substantiate the results of The expected four We’re different planning meeting prepared guidance required involved at studies in the The FDA request previous development product means of interim using expect we quarter be the will submitted of being

As the with we’re identified, steps. stop of LOCK-IT-XXX the to to DSMB a efficacy FDA early result we’re next concerns looking on for were recommendation safety engaging and now forward

assertion Now agree LOCK-IT-XXX should using that with of substantial hemodialysis is and solution FDA effectiveness evidence of loss Neutrolin the patients. catheter CorMedix and safety for shows provide

forward patients Neutrolin an to with NDA CRBSI. prevent them move expect for in to use We hemodialysis for

include is and pages, undertaking timelines manufacturing course agreed Now share which and a we’ve labeling of And XX significant will volumes require once many an and action. encompassing more and information NDA FDA of of of big thousands many and subjects clinical coordination. and a sections NDA at chemistry, with We’ll this with stability, which consist more. data [indiscernible] and met on preclinical different of specific claims work

We of back to during the meeting XXXX. expect call quarter Baluch. FDA turn of Khoso I’ll have now fourth results the to the

Khoso Baluch

decrease is continue for the we available direction no the as enter will Thank to drug at with application. CorMedix quarter drug collect, that LOCK-IT-XXX which with three, are we clinical to is study four study, data by Therefore, expect you, Number properly Paul and we two, all closed enrolled subjects Paul clean Liz of and data provides to new covered Liz so towards completed expenses is you the the the prepare, by of XXXX. as the the Neutrolin and further the as exciting expected the be and safety preparing process development the Number to process remaining of providing are was we CorMedix the next like in reemphasize FDA cover the indicated, will more being it’s Paul. up in we most the winding insight discuss be the subjects now have with an the a Number for common are plan. meeting are in development of development study, that updates for the outcome one, points. pushing trial I’d Neutrolin. the request to we respect steps to will September. discussions with the Based couple into you a plan. be investigational final What of down we with final to FDA, stated, on and are

has me track a is you to Let there that with and hemodialysis medical fast catheters. remind QIDP both need recognition venous prevent infections that Neutrolin in significant In status. patient unmet central

Before to at our want strategy review to Bob I turn to over financials, reiterate the call I CorMedix. the

are We treatment XX employees of time consultants disease. the company the for prevention with inflammatory a and focus full development on many infections and clinical and products

an in will four with in our Phase turn the FDA call forward opportunity With to Neutrolin I now and have exciting Bob. that, meeting near-term asset We potential the look Bob? X over quarter XXXX.

Bob Cook

With to net quarter second June report Form share, loss will in I contained approximately you financial our XXXX. our urge $X.X of our in the XXXX $X.XX file $X.X company with a was to XX, or XX-Q more loss quarter read business. compared second the ended the for of financial million, discussion close of per results, results. XXXX a for The complete of you, share, the Thank its report or respect information per Khoso. today’s before $X.XX net quarter million, on

loss was per or share. million XXXX the net in $XX.X in quarter comparison $X.XX of Our first

expenses with to efficacy XX%. in decrease second During expense in declined quarter, of with the in away due period. while occurred declined study compared the XXXX’s million R&D XXXX trial in $XX.X the our the of to our XX% July. other that enrollment the a XX% we quarter, first clinical quarter $X.X from million, the $X.X with first as LOCK-IT-XXX focused Operating million to XXXX approximately previous R&D $X.X from expense, associated declined declined XX% million, from second compared quarter and interim attention towards costs analysis clinical

total Our quarter CRO, was which together the quarter $X.X expense trial the year. operating incurred by to fees, positive the declined expenses in expense decrease expenses study investigator million. our our related during felt broadly to clinical million and last XX% was second or third-party this clinical approximately The expense $X.X XX% of of from in the

our LOCK-IT-XXX presentation. increased reduction staff $X.X Higher SAV increase million and X% fees While from to quarter. primarily expense site The XX% expenses used XXXX. with with million, with offset of million half the in in loss six first in the $X.XX employee our in-house a the only quarter expense to net first share, was With or $XX.X of accounts compared used payments of XXXX. June compared $XX.X million first due XXXX later in reduction Cash in of considerations of the half million million sales LOCK-IT-XXX I operations expense in payable regarding to for approximately second $X.X little $X.X incurred the respect XXXX to our cash in operations per in the increase with costs of or second during half while the Operating in results for was of our the quarter primarily for we amounted $XX.X due Cash an of was the in expenses in amounted XX, CRO, June used ongoing the my operating quarter $X.X increase per financial share trial study. in to was a use and operations first sequential $XX.X the increases with this million ended a used this million accounting assume the XX, months partially The was compared $XX.X net are expenses team $XX.X related CRO. cash $X year increased SG&A million. of due half XXXX $X.X in in of ended during clinical to expenses million a a and this to on compared study. XXXX in to performing million R&D. $X.XX operations certain last the $XX.X approximately the the to to loss approximately cash compared overall marketing the increase in operations first legal the an the additional reduction million to of related of year. analysis significant loss in first the and to hired second small our half months and a efficacy a net payable during six as financial higher significant offset expenses quarter that of comment activities reduction and despite monitoring operations year. clinical this expenses million reviewing to will additional in reflecting X.X%. negotiations during year. quarter are delay XXXX, interim occurred suspension further in result build during up in in The our in used The a the Operating accounts of or of

sheet at $X.X expenses payable total XX, Our March a million accounts and in million June XXXX combined with approximately at $XX.X of compared accrued contains balance XX.

essentially accounts second declined the During payable quarter, about while X%. accrued doubled, expense

As our CRO. Approximately June change in accounts to be presentation, our payable my the occurred due LOCK-IT-XXX million delay ongoing The this negotiations payable of our efficacy in through earlier $X.X CRO expense of XX final for significant I at regarding determined the accrued are and analysis outstanding negotiations. which the disposition mentioned interim study. our our will to with

payments negotiations continuing. suspended are have while We

trial clinical and as our balance be work will we CRO us a of continues the We down the pleased closely wind to regulatory part of are our the that collecting and submission. our data analyzing that despite with disagreement, future complete

the $X.X raised DSMB our our to stock higher to regarding our clearer, program planned market’s trading significant large to ATM million. we volumes development after taking additional our fund the hold million extents with and to on utilized our proposed facility recommendation. ATM winding prepare of and further the for cash with the once we study reaction with down we have we XXXX, today financing. The XX, realized financing $X.X our respect We after a significantly and June plan from of needs million, raising will without FDA June commissions LOCK-IT-XXX prices XX become Neutrolin During resources of cost the and the of But the daily resulting the advantage very we future existing reach second meeting aftermarket CRO, CRO, the year-end Based beyond with quarter through maybe a through FDA operations have the of to raise negotiations cash agreement with to additional ongoing at ultimate our to upon negotiations believe to or our the final we Neutrolin. funds. the disposition path depending the additional need development without able the continue $X.X

transaction consider best would financing will funds such believe Yes, We in earlier planned to our be opportunistic operations. our a sufficient ensure for we shareholders interest.

will as I our to We update his possible. Khoso for negotiations call hand soon closing And CRO provide will remarks. back on an as that, now with the

Khoso Baluch

a before. and that and for solid practice of CorMedix The robust better processes at consultants analysis. last to conclusion the present Thank than with past you, XX everyone employees efforts strategy we’ve developing the a been XXXX months, evolved I leadership over want as early directors, paid study led taurolidine becoming thank team has capable interim by the company company delighted study on and to LOCK-IT-XXX with a positive off. has Bob. and the ever who and I’m commitments. the franchise the came involved been in bucked

look support and look to update Thank I take of the FDA the the our via with website I to CorMedix. a We’re collaboration will the line. you pass to forward you back across CorMedix providing with your forward with to handful call. for And for engaging of Neutrolin both conference Q&A now moderator called it via CorMedix consultants the strategic of finish

Operator

from will H.C. Selvaraju line session. Wainwright. question we time, of with a of Ram the question-and-answer Instructions] first this question. Our Please At you. your Thank [Operator proceed comes conducting be

Ram Selvaraju

taking for much three my I very ones. question. thanks quick had relatively just Hi,

for the LOCK-IT-XXX possible study wanted Firstly, interim it provide analysis us Do Khoso the the information? that to you be with time. see if of at p-value from would you have I to this

Khoso Baluch

a little for Thanks, going and to I’m level question. then cover add a very your Ram, question. It’s pleased bit. I’m at macro a to interesting

And the which recommending resulted met with however we blinded as the that as be endpoint, team. the First, significance study remain for DSMB mentioned pre-defined to study in respect the I primary a stopped. target statistical

So we don’t p-value. the have to visibility

Ram Selvaraju

Okay.

Khoso Baluch

question Next Ram.

Ram Selvaraju

what Do you kind Neutrolin the results, based a a pathway be to sense infrastructure Yes. approval believe the of of that the covered would specifically launch LOCK-IT-XXX would is assuming reasonably the it have on you timeframe at for design that juncture of by commercial and there to take LOCK-IT-XXX this indication study.

Khoso Baluch

very your build understand commercial a small a Thanks, organization in U.S., in commercial have the Yes, cases for open and the we strategic when challenges market company very long Therefore, I it’s as like, in our look bag. of Ram, in what would plan a we fully for partnerships, only risk particularly shareholders. faces also product the have but be question. the here identifying and will do in draft some to in a one interest infrastructure best you parallel of access as proactive be

Ram Selvaraju

you be of spent the for what if the Bob, is going I base very for Okay. sense quickly to Bob, give can forward. just one may. likely a company And R&D us quarterly then question of

would you out LOCK-IT-XXX associated that expenses words, What’s spends? the quarterly the classify with winding that might spend. associated including other of with LOCK-IT-XXX. down R&D the R&D costs be If not dial with what done In assembly all you as you’re Basel FDA once

Bob Cook

most where think XX% the about the about the from numbers, you was said could trial we cash I quarter spend expense million, of the second see that that our R&D total. of $X.X as was see You

any might that, might what for at any be not look the going hard the of slight at we of and a you’re time roughly all, burn study costs. for level on just looking base at company. if being operating but month. that at looking point, months clinical And if this per there for Then next see you’re a So the the about might to $X.X increase strip decline, in just be be think it’s not the several out I at we’re might there expense million

Ram Selvaraju

$X.X or month And per quarter. that’s million per

Bob Cook

month. Per

Ram Selvaraju

okay. month, you. Per Thank

Bob Cook

Okay.

Liz Masson

Thanks, Ram.

Operator

of Our with question. Capital. question Woods the proceed from Please Alexis your LifeSci next comes line of

Alexis Woods

Hi, success congrats trial would to, your on be just NDA analysis. can a agree LOCK-IT-XXX be how timelines speak if and indication long an not interim the What to and kind for again I – next sufficient you wanted study study for what FDA was those for would filing. does if you that exploring in making announcements the might of that take.

Khoso Baluch

your Paul? it on Officer. Chief to Alexis is Paul, who Thanks, question. Medical here for I’ll pass

Paul Chew

Hi, program. the FDA the short to X earlier, two we to will in I do. as of Alexis, to said plan Well, and thanks read on Phase speculate do But think [indiscernible] studies the for as I far a as question. original mind what the was

do after another indications, going And the still that few are shape central so program shape would venous for we a Alexis, and would FDA. obviously to early discussion we with CVC, if what on the catheter

Alexis Woods

it. got Okay, you. Thank

Operator

turn I Khoso closing would remarks. back over now like conference for to to the

Khoso Baluch

call. update our forward everybody and company’s said is like to I or moment and Thank FDA meeting on want a just provide everyone, it I to history an with having a conference us in look for website we Well, this call. joining our then the through on the being able either you much. thank Clearly, to to very critical

very So and have great much thank a evening. you

CorMedix (CRMD) 14 Aug 182018 Q2 Earnings call transcript