CRMD - Earnings call transcript Q1 2018

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Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to CorMedix First Quarter 2018 Results Conference Call. At this time, all participants are in a listen-only model. A question-and-answer session will follow the formal presentation. [Operator Instructions]. is conference this note being recorded. Please now your host, would like Advisors. to to over conference the Monique turn I Kosse LifeSci from Thank you.

may You begin.

Monique Kosse

with quarter provide the Chief Executive LOCK-IT-XXX of Executive to afternoon, the efforts of Liz CorMedix respect On Thank Masson, welcome an Officer an programs call XXXX update Clinical to and provide first matters. on this Baluch, Good Head call. clinical ongoing investor Operations VP the Khoso you. today, update and will will conference company's and the CorMedix complete to analysis. other interim

then to over Officer. then Financial the session. the will We we the turn turn Q&A call to Bob Cook, will remarks, their over operator Chief back call a After

would concerning following make Before turning like the to forward-looking call remarks I the over statements. management, to

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

Khoso Baluch

you Thank update our with review where today our joining to us you, thank like an XXXX we financial performance call you and on Good for provide of afternoon first would quarter and activities. Monique. our everyone

in driving clinical sales neuroblastoma plans. and development on and value our one update on pipeline for Middle update planned in that Europe and interim and and East, ongoing specifically program, previous critical calls, Neutrolin As our the our we areas X for taurolidine-infused including analysis, provide devices Phase brief will are medical most updates status the our on a XXXX trial Neutrolin key the CorMedix, of quarter update financial

and analysis interim our Neutrolin, priority. is So let top LOCK-IT-XXX for the begin Phase me on X which clinical the ongoing trial

Safety anticipating adverse currently make in analysis obtaining encountered. Board will further no are XXXX, and that process complete Monitoring secondary We the review interim to the endpoints assess delays needed are Data data July recommendation and our in additional the review assuming its serious to events

quickly as join order to the efforts provide the on insight and In and Executive us continuing process. Head you is our afternoon are this to further have analysis we as and asked efficiently complete Liz task have Clinical to this review study We as who hand, Masson interim VP of to clinical details data I and color to possible. at Operations provide

Although made it meaningful our has taken longer than progress far had we have call, anyone last since expected.

preparation companies. process. the the plan with in cooperatively we over and to the to business regarding will While the details in more Liz CRO, negotiations them all multi-sites continue with negotiations we CRO, includes clarity the work our now world our for to regarded trials running have including interim Liz? to of We call we the on I highly an which to update largest whose review clinical one the perform of most on around the efforts nearly provide and with is of once the turn our and analysis. delay financial CROs are considerations XX on based remediation top outcomes provide further world, in pharmaceutical

Liz Masson

be I’m Thank on this and delighted we’ve to what provide join you, Khoso. been doing. details call more to able

source-verified is to for reached the the time study the we to December. focus up analysis correct required XX in in early remains CAC-confirmed CRBSI Our ensure the the that subjects all and for the data interim

data two number, the the ensure for as of cases cases catheter removal cases also Remember, other data generating FDA. presents sought subjects center while nearly significant. are is efficacy the of volume we secondary at collect that but volume that Further, with loss all have off with we are us to team settings. have submit in medical of records that, the the review an of To is hospital, extraordinary makeup relating ensure to dialysis interim week only XXX thousands a protocol a require the to undergoing comprises three combined The they acute assessment that the these done and treated study of we and treatment including the path. XX may permitting XX we need attention emergency are dialysis subjects not medical to of are for an small patients or patency. amended sounds complex with cases years at happens care review. CorMedix While on subjects over an endpoints data like hemodialysis analysis per times needs these that that data of first onus Further, while XX agreed occurred what least

data these Now, not the interim the some be of prior transfer could we you of anticipated issues CorMedix early may to the February have wondering for in to how analysis.

visit Let and using by there of me final go studies goes study analysis when sponsor into the inform process question. the help be data as and data was decision lock data previous decided independent our its has missing an When and to accuracy sample perform FDA and sites transfer, that inconsistencies When just post for for is analysis. the verification to the further was interim you’re there take effort the case. for subjects. of to early incomplete edit that of monitoring at that such making case is XX of learned on LOCK-IT-XXX, over data the senior The addressed data the called had that was data were XX potential we cannot prior CorMedix unfortunately on checks is and frame reviews scheduled contrary a either team the through the in took this data cleaning when study All the and and and requiring verification through the that of a we statistician that interim source study. XXX% the the the found not proceeding specific prior answer termination they when XXX you. with source In oversight time of is essential interim material progress reviewed the to we or needed an required perform full be cleaning an This completed. completeness to to same at and we subjects analysis data that CRAs this to to nearly time a trial, engaged situation statements, then monitoring

our to today, have identified data many endpoint. relevant missing of As entries we

XX% Our accelerating. of team approximately and source verification reviewed pace the and of the source-verified has is data

not cases. XX work work to schedule on of past the This are XXXX. We CRBSI complete impact by June the does integrity of the end approved this

XXXX critical December we CRBSI We cases basis. this continue on to subsequent are I to submission occurred deadline. prepared cases turn ongoing back to tasks performing. early potential for being now new CAC you helps which These to will Khoso. the understand call over the I an hope the are identify

Khoso Baluch

you, Thank Liz.

our you and update, mesh, to provide a taurolidine-infused hydrogel. want pipeline, the brief devices on and program. both taurolidine-based I to our the neuroblastoma Moving suture, medical specifically

to development to not so the the option light the that from we the FDA to taurolidine-infused Premarket First, medical a we medical that of employee care devices were with not device the medical X% just of device approved. to would drug-device differentiate feedback XXXX. we drug intact requires interest forward FDA X spent regulatory discuss who weight showed the the used trials Class received the therefore devices are from an devices in a at macro that pathway can regulate hydrogels, early I’d $XXX,XXX inhibited results one taurolidine healing. the of would during to to We present the the is early of a first healing with Neutrolin programs to study as was for preclinical encouraging they faster [ph] XXX(k) them need the with Approval pathway intends like combination. FDA CorMedix’s have the today’s the if the to taurolidine is PMA, and application wound for in of Application, days CorMedix step partner completed effort. but for At part in the point structurally next We none these to new level, wound sutures the The In standard a bring LOCK-IT-XXX when out preliminary. quarter studies infusion, continue approximately market. and move which up these plan were moving

that activity predicate device of the on Neutrolin. can no of Although have of hold medical no the at safety presumably effectiveness. this a the be proposed [ph] assurance and Class risk To there most be X approval will put development device, FDA reasonable still time and based on appropriate pending end we assessment

quite these segments market own. protection believe for and sales devices worldwide ceased that partnership a annual unmet for of to as express open have asset each addresses but sutures, That are for strategic billion said, and $X our develop outreach The value We within are parties are to potential segment. or we established on mesh $X attractive. interested partner anti-microbial with need significant us interest. we a to are meet and further being billion a each Total product these hydrogels to

Now neuroblastoma. moving for treatment in the taurolidine neuroblastoma currently in combination component development our is program, to preclinical Neutrolin. company’s key Taurolidine lead on product is the as a

fewer diseases with XX, period to funding, research of As costs, the Prescription by to tax for taurolidine or or Act granted clinical the trial and U.S. drug of as Orphan novel neuroblastoma. granted XXX,XXX CorMedix fees. eligible User drugs provides for of distribution, well affecting the treatment market biologics exclusivity February design is on credits the drug filing rare of FDA designation CorMedix’s the XXXX upon waiver The Fee mentioned previously, designation a assistance, designation U.S. conditions approval FDA are and that for patients seven-year orphan drug in the grant that announced the called than treat potential PDUFA CorMedix commercial Drug as for

data to potential be to continue develop and continue significant encouraged in to work partners and the by other taurolidine poise indications. have received continue preclinical we We neuroblastoma to with and will

company sales cancer-focused asked been development Neutrolin to several and obtain goal I to have taurolidine the East and Middle business in into Europe with clinical our about marketing approval. partner our advance Our appropriate insignificant. are is times and an ultimately why

In of these thrive To compelling cost competitively the in to for will in and end, position these to inroads goods is when partners alternatives of little data randomized, cost been citrate market. in solutions. expects potential be the to answer the we data East of of There Europe, penetrate the significantly robust continue in significant majority are our that make citrate no not opinion that concentrations goods. meantime, sold low and on catheter of we to me with need continues be with The results East Middle CorMedix reusing have Neutrolin. are the catheter show used that data progress European, double U.S. of study, this prices. its a this In the and market. are this anti-microbial markets. we CorMedix the question. firepower markets, the distributors do market to prevent trials for are different at the seems and in our Further anticipate blind have market, competitive making The CRBSI. coupled to to this in order solutions on Let that control LOCK-IT-XXX has lock and better several variety Middle clinical safety reducing citrate-based a efficacy identifying which strides on from There markets very concentrations

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

a XX employees prevention focused now company on are and the consultants We and treatment inflammatory development of full-time and diseases. for infectious with several products clinical

information Phase with for and Neutrolin. exciting opportunity the analysis in necessary are strongly in We stages the an of interim for believe We of gathering our the final X we LOCK-IT-XXX. that completion review DSMB potential the have asset the

including am he several Omada and European major announce and President, Chief his U.S. consultant Bristol-Myers Chew I the CMO He Paul the joined Medical was Finally, the R&D of served and most distinguished advisory where at a CMO. U.S. pharmaceutical Food pleased training Head. recently Medicines had that has Senior as Global has and Squibb history a career, Chew, held by companies solid He Dr. FDA, Vice the Agency Drug working positions CorMedix Officer Health. with Administration, Dr. of Sanofi has a has FDA at cardiologist executive as to training representation including positions. held Advisory more of Hopkins and completion. focus group Liz her the spent study education LOCK-IT-XXX over and team lead immediately he various XX undergraduate the sponsor now will analysis will the on closely and has at medical Paul that, faculty He with and turn With than received he to supporting and has Scientific EMA where years Committee where work to interim the joined Johns call I and Bob. School the University Medicine Advisory Group. the his and Over

Robert Cook

with $X.XX the first million the our of compared net $X.XX of results, in to loss in per was on contained XXXX. much, results before loss urge XXXX. The Form per and close share compared for results will respect our complete company the share $XX.X with first our financial $X.X you XXXX quarter to of period ended very financial the XX, more Khoso. its for a XX-Q report analysis With Thanks March file the an information million report or for comparable a quarter today’s XXXX in a approximately I of of net business. quarter explanation read or

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

a decline to to expense we period. while expense million declining continued study trial quarter, the previous in while decreased of the quarter compared previous unchanged experienced a X% with the million ongoing expense and the related Operating other decline XXXX flat. approximately XX.X XX% due fourth increased from roughly of or quarters with to clinical $X.X to first first XX.X R&D, manufacturing XXXX, were by higher in in R&D million remain XXXX’s clinical expenses compared to in During XX%. expenses quarter costs XX% decrease other LOCK-IT-XXX

accounting in reductions XXXX. net enrollment the operating increased $X.X all during The employee million higher increase in of site quarter XX% reflects a primarily accrete primarily trial seen business to from to the and total higher the virtually certain during takeover expense of accounts LOCK-IT-XXX development, reductions and operations response was slowing to legal used additional staff the for response primarily in X% end related the expenses the reduced in trial included previous during quarter fees. higher the travel in in in a used quarter was incurred as $X.X areas study which [ph] fees had well with subjects efficacy to million hired increase to business expense Notable remediation our million our was in the decline and from the our in sites preparing except expenses a clinical with Cash balances declined expense quarter the quarter. in first delay XXXX. first increase with study. modestly as related quarter patent or payable to and $X.X payment $X.X expenses. ongoing compared the in to compared compliance and we investigator Cash in at CROs. quarter declines considerations due that ongoing CRO expense with expense participating clinical approximately The of monitoring and financial million in clinical the analysis the from quarter efforts quarter SG&A XXXX in payments and of reflecting during fourth Our operations negotiations study for to for in of increase last XX% the consulting payment XX% regarding interim of approximately

XXXX with XX, options. for the in be intention replaced us of the on split of will quarter approval our negotiations those equivalents view our we third our quarter, them it, interim of a program price, discretion. the to able options remediation the to for million of facility able of effects The our of permits price scheduled. first to conditions operations fund the ongoing uptick expiring protect approximately split the stockholders any to In and a in existing a reverse split, because the negotiations, us April performance guarantee cash and be into and we stockholders number through March from XXXX as the and outstanding a no has warrant complete we reduce while the CRO, the stock’s went of to-date. both exercise in warrants and to the outstanding favorable Based to believe an and we favorably market will time-to-time $X enable or we with currently March will up and our common approve and binding SEC was a of program. currently the raise or financial that statement stock or that price warrants backstop analysis allow reverse cash ATM our we obtaining up registration on outstanding. plan those range CRO. the raised On the is facility in the purpose effect company’s are During of received to and term that million million. modify at $X.X June May Subsequent Board the in ATM approximately Board ATM X, for At-the-Market of reverse the Board options to can’t split a considerations special on and impact of million had which to to status the with effective stock of negotiate the statement for We to predict exchange stock decided new asking delay we preliminary have ratios we with program reverse to which cannot and the utilized hold hope interim analysis that year We effect XX.X finalization sole our the XX, filed the our resulting current our implementation Cash our a to proxy $X.X a meeting sheet XXXX in at our from new through which we March. a had not

in trading explained our American stock. we mention the reverse common to approval common American, listing shares shareholders In complete our our an of as success. statement, company’s by proxy both made maintain filing, the affect to time-to-time required after relative our not split. on for terms about Because near be a connection NYSE financing NYSE alternative is that we Exchange. nature this to statement split maintain without from reverse after funding to not available offering. As our important marketplace. The stock have The possible offering proxy to also stock. only our completion preliminary to our conduct of our rights participation, sized the participate reverse believes issuance. the the issuance will stock by of enables reverse from moment, future stock the long-term and will mechanism shares number Securities authorized we of our existing believes intent have critically would well a financings for believe of Board available in to with shareholders the the other in shares ability or million term their stockholder of it credible properly which XX or ownership effect stock preliminary OTC for ability the will share number can only in is sufficient enable to If continue over-the-counter their corporate At additional market quotation We on all rights pursue of uses as offering need stock its other receiving of the appropriate the Board company’s have current identical to the especially an split our our to delisted were the on split enhance the common operations

is financing for shareholders participate solution financing goal plans. this Our minimize and in opportunity company’s provide existing the to to with the

We more weeks. the will back our issuing closing now over for plans call his Khoso coming I that, remarks. be With information to will hand the solidify as Khoso?

Khoso Baluch

study experienced the delivering. and LOCK-IT-XXX we on team analysis. The most the over assembled that have the is focused few is interim last hand on task and critical The Bob. you, Thank specifically months

delays call that back it analysis events. the XX now Another the quality trial I monitoring would open the interim team like or benefit With at I to that, the upon the of end hand now operator. allow will reaching that avoid doing of it to unnecessary is will is for our to whether this task questions. is the at with it us

Operator

Thank you. session. a At this Instructions]. question-and-answer time, we [Operator will be conducting

Alexis with from is LifeSci Woods question first Capital. Our

Alexis Woods

Thanks hit just confident you more speak confidence July for of that for the confident you’re able readout question. if know past. XXXX meet to and the you why now you’ll that my that timeline opposed that been to have how Hi. taking to wanted be I in you’ve could level to you’ll interim the as

Liz Masson

Sure. Thanks, Alexis.

We have and regularly process very of a a rigorous reviewed. undergone with the experts dedicated a and to planning teams built strong number gets process data integrity of it’s the that

and with So team the timeline we’ve very in this I’m put our place, that at confident that point. in

Alexis Woods

devices. Okay. And more Thank the I question one you. to then related just have taurolidine-infused

those to If it’s you going the move for be to see you if to going or eventually be programs if steps clinical? need preclinical, speak in And could it’s and order preclinical to to next the into what then would clinic? it

Khoso Baluch

you, will I cover that Thank question. Alexis.

studies have then standard and go going feedback situation sure the the us light on now received effort right from of be got our to invest from the for the some segment. we to not we just XXX(k) in pathway we to work we’re we are the FDA is There’s clear to hold. would As prepared products the would have as approved At a until forward we what on in time minor the or work the changes at we going done moment in in that marketplace. down I will what the statements, any But care more do the to to differentiate path ready be the to that going Neutrolin put do we have indicated make be to pathway. of doing right PMA

Alexis Woods

Okay. Thank you.

Operator

have of to we end session. would question-and-answer call gentlemen, turn like and closing the back the the Ladies for to remarks. I Baluch Instructions]. [Operator reached Khoso

Khoso Baluch

and you employees, Thank listening our for look I’d providing on our very good for continue again their members you for you their information in earnings evening. work and capitalize guidance and have dedication, thank consultants call. to for ongoing our to much as to shareholders today. support. hard Board our We next further and their updating our Thank full-time developments to like a forward everyone

Operator

concludes This you Thank you. today’s participation. your conference. for Thank

time. your lines at may disconnect this You

CorMedix (CRMD) 15 May 182018 Q1 Earnings call transcript