Rockwell Medical (RMTI) 11 Nov 192019 Q3 Earnings call transcript

Good day, ladies and gentlemen. And welcome to the Rockwell Medical 2019 Q3 Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer and instructions will follow at that time [Operator instructions].

As a reminder, this conference call is being recorded.

to conference like host, to now Ms. would turn over the your I DiClemente. Judy madam. Please go ahead,

Thank to of Katrina. call. Investor you, Welcome representative This earnings quarter Relations is results XXXX Judy Rockwell DiClemente for In-Site the Rockwell Communications, Medical. Medical's third

I laws. begin, that note forecast, may, believe, or will, Words may such to will meaning of expect, certain within should, continue, predict, forward-looking as are project, statements belief wanted or the we could, forward-looking anticipate, the discuss similar we regarding Before statements matters constitute or intend federal potential, estimate, expectations securities current plan, statements. might, expressions intent,

available While release reasonable, subject any to undue the uncertainty. Rockwell date placed and are to which on inherent statements such be these believes reliance forward-looking which should information are are us of forward-looking on this not statements, on based

change. efforts and liquidity of improve recently plans Triferic, announced the existing for our and and business. upon filings, based various IV CMS's those and are SEC Triferic Rockwell's rule risks for statements of which subject capital; control Triferic submission potential materially recently the and of final our and the commercialization maintain, uncertainties, Dialysate about and reimbursement and IV resources; Rockwell NDA grow to include: set including and duration of statements timing forward-looking Triferic; current and IV Dialysate pricing for without different. other including capital unique limitation, for are and Powder success working beyond many to products; are success TDAPA; be profitability other Actual for J-code announced results uncertainties Rockwell of the in subject regarding and the status Triferic; our estimates These our Risks market Triferic expected to of products, opportunity eligibility forth our assumptions success for the for and Rockwell's could liquidity Packet; eligibility

any call and This statements, This Investor of November whether rebroadcast, on events update for on except law. Medical's or accessed information, call disclaims be future otherwise, obligation any also alter or being the conference new result can XXXX audio as same be webpage. is X, by accessed can recorded on expressly Rockwell webpage. to Relations Rockwell a required as

call. Present will President Officer on and of Stuart today's Rockwell are of Medical; answer Chief Directors. Chief and Angus Paul, the be John following Executive Financial a for call Smith, Rockwell of of available question and and session Medical's Rockwell Angus Chairman Stuart McLaughlin, Board Medical; Officer immediately

Stuart the Rockwell I call like turn At to this time, CEO over conference to would to Paul. Stuart?

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John. Thanks,

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on As we representing on X,XXX as with contracts of over clinic patients with purchasing clinics, signed customers. XX, accounts had XX September XXXX, therapy

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discussions. program sample evaluation clinics generally to our for months, which enables reminder, three at a we point, up contracting that's As period to a begin Triferic

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medical of the commercialization and education collecting globe, world organization. also adopt and Excellence plan across providing this elements with Triferic medical of affairs KOLs, the Centers to are data, community. interacting to real analyzing To our of Triferic, the dialysis and and key development include medical strengthening enhancing further capabilities our The with we support contracting

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more We details will as share appropriate. with you

rates revenues While patients. scale Triferic A transformation establish and challenge a growth progress, the we in we're at accounts, a three ultimate next making to have of the we and over new But growth patients good to in realistic managed care the And time as and remains also our way anemia to of expect about change we years. goal meaningful ramp this of five involved move take the haemodialysis we're wholesale to will is forward. fully very on start solid execute. as our orchestrating treatment standard in

System specifically TDAPA. XXst, rule. application The drug July Payment be Prospective In certain final only issued the ESRD rule as position starting separate October rules, types NDAs, CMS X proposed final final XXXX, not On eligible the from released in for be TDAPA the for for CMS FDA, year. or rule reiterated reimbursement the rule states their that next will will or classified Type by that new eligible the final

peak TDAPA, TDAPA, for the it be the Accordingly, Without is will Triferic a clear, therapeutic. that To fact the launch despite significant to to TDAPA benefit not be will believe interpretation believe rule, under uptake. IV that time IV our and slower. be have Triferic is provided innovative curve an would the we incredibly eligible for sales IV final we Triferic

enthusiasm for in does still and portfolio, of an have our us. incredible this dampen we the opportunity However, Triferic front

over generating outcomes in cost the disrupting invest this the our the clinical, gross to associated most. economic management And while demonstrate accessible to making pharmacoeconomic this next the data who continue standard-of-care Triferic. We'll need data health transformational with for years. it make importantly, we And in the broadly believe will anemia patients therapy to three to attractive believe goal and for support five structure an Triferic to we the bundle, enables us of margin

call Before are I to to but we remain we Smith, unhappy leverage I hand current in the over emphasize about valuable for Angus want steadfast that create our as the shareholders. assets price, to commitment all our to share value management

that leading strong platform, me portfolio, and resources, and medical the we're commercial U.S. let our aligning to achieve well of building reiterate across conclusion, our as a in globally. highly So the Triferic as skilled capabilities, goal both in all

that, progress and these we in is not days the on a key continue revenues metrics, of will And focus early believe follow. the data indicator. engagement KOLs. necessarily we'll do to if initiatives making Revenue Rather, the we on adoption

our quarter Smith, to Angus over Angus? call CFO, our the turn financials. review now third to I'll

Stuart. you, Thank

the like to I Before on few of financial themes. I results discuss a would for XXXX, comment key quarter third

valuable First, believe here growth forward. financial as businesses us a foundation we give have we we that for and flexibility solid move

We the Second, foundation of over several business year our in dialysis. as last and ensuring enable investments sales, development quarters, the platform these we efforts coming and commercialization with execute our to plans. investments required a goal Triferic in made growth on us the marketing, of our critical build sustainable believe have are medical R&D in successful portfolio we to the for the

believe, transformation stages create our are organizational for early we an and at Finally, stakeholders. we and very the value of financial we'll

providers results. to abroad million in in to of quarter $XX.X customers third for increase compared decrease $XX.X million and the $XX.X due $X.X months international to offset during third sales million the of for U.S. with September an sales lower was the to to primarily ended sales of haemodialysis million three ended quarter sales sales XXXX. dialysis of the three our The company's months and were Net Net XX, XXXX Turning XXXX. contract to by distributor XX, were DaVita. pursuant September concentrates

to volume some compared sales distributors believe, in the due loss was by declined concentrate Latin International to which countries, nature. certain American year in in our cases temporary prior the one we of of

countries, American distributor with other our to regain these we countries. We also to to have access our in engaging are access concentrates worked some them Latin of with expand and in products

months to XX, XX, for months September for the XXXX. $XX,XXX ended sales Triferic of $XXX,XXX Net were three September XXXX compared three the ended

revenue of Peoples' ending to September XX, XXXX each U.S. and ended license Triferic XXXX under For included approximately months three three also of the $XX,XXX Wanbang XX, sales approximately of and Triferic XXXX, sales September months Triferic the sales September the China customers. net recognized $XX,XXX for Republic Biopharmaceutical. with of company's included XX, deferred net product

profit expense the the of $XX.X sales Gross by decreased of Cost compared the third the third XXXX. was million of during XXXX quarter to sales XXXX the compared an million to concentrate primarily $X product from million due cost $XX.X during quarter XXXX a in company's of quarter of of in and for of third increase by of partially quarter gross in reduction million increase in profit offset Triferic gross third sales. profit the $X.X to business, inventory reserve

Triferic expenditures R&D partially Operating selling, our loss due decrease third compared XXXX. third investments just in increase operating a was XXXX increase $X in for and loss portfolio of $X.X in I by are that in due million described, the G&A in to was profit quarter in quarter marketing the we gross of million expenditures. and the to The the decline making to our offset

quarter reflects XXXX investments $X.X the the Selling and platform $XXX,XXX Triferic. of million in with we to making the third support in commercial the launch compared The a developing expense sales third XXXX. commercial of were marketing increase are during and during marketing expenditures quarter of

other other activities insurance compared General costs and and from and to during of of during the departure with the $X.X XX, in including due The XXXX, during months with XXXX offset three administrative million decrease million matters, ended and ended primarily partially three months in various directors expenses million the by certain $X.X executives were September a costs. legal premiums is certain $X September associated increases XX, XXXX. stemming litigation decrease

$X.X quarter of medical increase building and as of development during our medical was were capabilities product with in and $XXX,XXX data staff. million that investing world including compared the to internal XXXX. the The the we company's generating the Research expenses mentioned quarter the and to earlier, use education to XXXX efforts, as from of third third of company's for real due well Triferic studies medical development and affair commitment support expansion

due expenses of including on increase and development research We we Triferic, commencement trial future the pediatric IV additional development that in the initiatives call. medical expect various will our have this of for product the clinical mentioned and to Dialysate Triferic, and

$X.X the of of net share diluted or third per quarter diluted for in per or of basic loss loss XXXX Net the and XXXX. $X.XX million quarter was $X.XX $X third and share basic compared million to

company had for of quarter As approximately of total for and third investments million. cash was the of million of million net XXXX, used and and million. September $XX.X cash $XX investments the quarter The including $X.X the for in equivalents sale. XXXX liquidity of $XX.X XX, $X.X million, approximately operating cash activity decrease available was total And cash in

alternatives. two As as us provide Triferic valuable assets in potential with our Stuart including business mentioned, move forward, we financing have flexibility believe financial we we in Concentrates that and non-dilutive

call now will Stuart. turn I back the to

other of the transformational not Triferic wide therapeutic ESRD closing, believe promise, reiterate but in we a In excitement a states. also business. me our let holds disease in that variety you, only great prospects Thank about is Angus. for our

that and our strategic goals. IV formulation FDA toward on this as year we Triferic and execute made continue bringing We to in significant the market look to approval, in progress have advancing strides

open we'll call Operator? Now, questions. the to

[Operator Brandon question Your is Fitzgerald. Instructions] Folkes first from Cantor from

Congratulations quarter. on the in the progress

we color X IV Firstly, launch follow-up the TDAPA this pricing? then strategy provide Triferic after for clinics? got you And larger targeting any can now think additional the Should -- how of I've still about won't think as have we around should you that.

I think that or solid use Well, is to IV use the bicarbonate to going Triferic. need cartridges in of the one haemodialysis you're IV of that about launch treatments important bags, aspects Triferic

solid So or around accounts we're bicarbonate have but will application, particularly a both solid This and targeting, significant have say, globe. all domestically a segments a solution. need the I for would that a fairly cartridge

on cycle, about to Thank it going be an data very usage? you cost call, we a update this how And your purely it done to-date. well, business complications, is about what think And that iron contrary question of a understandable. talked it ESAs as your then job And that you're we in saw saving my to or prime should to collecting. Is was longest to sales and you've you. conversion if that the mentioned And IV related the you've then, that's the in data going in latter the is, given good data collect is fewer around element study?

is that right world that is the ongoing it we and projects fact complex of the the So these now. to nature are collect real data, have

business mistreatments, well. and of this line, sparing make on some of transfusions, a groups. well array I top an on We want to inclusion-exclusion And IV between of think et as of have data, bit saving the around time. iron an different ESA mentioned take numbers have I array cost the criteria, can update we and But as call this of hospitalizations. cetera we the that sure data as

the standpoint from a we this time take time, to of data. believe bit it of collect does that And so

be results. soon able get so we present through the And as we'll as the to process,

my forward? how was like, just maybe you. should towards going Maybe quarter. directed It in management think looked one we spending can, if of I good Angus. about really side, more the Any color in expense from terms OpEx Thank

I of guidance, highlights, provided what a know. operating haven't I'll you you're say, We know because expense But looking couple at. as

the launch. bit a number come little the Our Dialysate through why the bit had we've we a second of upfront there's of in investments I to think to little front quarter, a And least of sales as this some marketing and down Obviously, spend make loaded part Triferic support year. and we sales year. that marketing has at you as be saw launched gone in the reason spends

been R&D bit year. a R&D through the this lumpy gone On side, we've as obviously, has also

main we the QX, during NDA the that million is the to didn't quarter. of for had One that in we have submission paid $X.X back FDA fee the back third reasons that in we

So if line fee. we with R&D less had, out where the NDA spend submission you in back with were more we QX in or

work it have development as quarter data in Stuart that the We coming start as clinical to the Dialysate up R&D said continue the we through in IV expenses mentioned. Triferic, expect and we initiatives well that go of as

the covered. only thing we is then G&A, I mention which G&A, And haven't other

started approved some As the of insurance under I fully QX, the our come we put G&A In said, rearview has policy. we down, were to because matters here. for mirror the in litigation D&O deductible

noise that's of those the to in our result of expense. in has some financial as started out matters, our come litigation G&A fluctuation quarter-to-quarter results, a of So been

Chris Piper Next question is Raymond Jaffray. from from

to circle rule. back I wanted the CMS to final just

CMS's this trying in is recourse? Thanks. no And decision? this was I guess, I about assume kind still you last no terms respect of the this the Like you even is all, it head to of use, there's You with go But that I the you final then -- I of much before I to your appeal should decision. you first guess, disagree what guess to either lot we exactly guess, that final, in any guys talked made word, there there's where with of sound a was where very is know language understand process? of know you surprised sort way. Stuart, misread, maybe second, rule learning, -- kind

did it strenuously take the to And TDAPA. not sense clearly, you. Triferic Triferic -- NDA just that representative essentially object Chris themselves has use thanks, the they true And from the FDA one to the was of which hear when way to tough ineligible be going of you classification we postured, was of good IV come products of get a decision, approve. look nature initially rule a -- was when not the you is scheme, the for FDA, innovation the at said

we There only trade support the group. of it groups associations also day, But the and the at sent the were weren't it and is. numerous what that same felt end and -- So is letters.

wouldn't I say surprised. were we

I modeled end the think we our plans business at view, with the the that that while margin still we strong of notion, participate continuing the think cost I structure have can all bundle. the inside we point it precludes as discussions day, Triferic. profitably believe I the very From with mentioned, with have CMS. And the don't we of

our And I my to there in I've and kept we four with probably a the want open And or order of dialog together space. door CMS of we the first with sit business to positions. they times. on -- So on over And we know innovation opened door was spirit board, in this I came year. reopened have last that should we when five down CMS, and been the work say.

of space. a drug think from very away is takes the of for the I and -- innovation the Triferic it So nature which don't important

helps. hopefully So that

question. more One does. It

the tell where down us respect and cash the pulled of stand runway, the options. with catalysts, if had your some you then example, other you any? milestones? I How Are that this and but So think maybe like in you've much just was going number quarter, on proactively on sort year you've financing of of this will associated Canada ATM? forward. And some suppose in maybe a got Q, I to come with filings, catalysts. China some of mentioned any and you for got non-dilutive those the

So great. go how you runway any extending the to on be Thanks. about would can give color exactly

in you use reflected activity ATM quarter. quarter So you'll the third the of use is financing the the no we net during the like ATM. million about quarter, at view proceeds The a that activity said the did point from financing a in see usage. cash ATM overallotment July, first, about had third associated of not of asked I exercise dollars came but marketing all only during We of with

As asked and we you Canada. China you about forward, go know

agreement that's China, I So $X with due the milestone, to think of associated or first on rather, meaningful milestone approval no license milestones milestone due that's an a speak approval. have to in milestones that deal the we And payment China no speak and of. have, upon million Canada is real meaningful

variety global in plans fund And as to mentioned look forward, we a different the look options partnerships go Triferic very we'll and think of that to through we this has both our as future alternatives bring forward. at existing rights potential to valuable capital. got to But We've our business as a we number got plan. two We've business finance at of go disposal our we've businesses, we've on call. got

Selvaraju Next from Raghuram C. from is H. Wainwright. question

is open. line Your

for you Marks appreciate This on questions. taking is I the Edward Ram.

some more of how those economics any Triferic, in need in lot And U.S.? higher of I IV just a Latin a America. push wondering markets, progressing Speaking wondering international consider and favorable some marketing of for there's markets, in considering marketing was international efforts those the you are if versus stronger

the Again, And the think, Triferic whether course, IV use Latin And with basically relationships. think of IV I I Triferic at for distribute been been talking strategy world, strong. and there's America for and as obvious particular, Triferic. that the U.S., you're for infusion the opposed the market quite bicarbon, is the attractive international model bicarbonate looking the that outside dialysate we solid fits a and toward better around cartridges concentrates version solid in always opportunity push Latin in of are the or it's markets to to using just heavy us. America around leveraging quite an is us

around and we're world, potential another we're discussions the a And as with to Europe from and Canada Angus Chile. in licensed approval one other Japan, Peru expecting markets, have We partners. in an and mentioned, just of in including China number

be will say of would a we the be Triferic. I number driver -- driver those will So in really anticipate IV the markets,

questions, more CMS the on discontinuing policy. the I just also was noticed agent CMS erythropoiesis-stimulating that Two monitoring ruling. first

for wondering build was previous I on then grant TDAPA Triferic? Just did how say that What that with of that of appeal Triferic. questions, them to led uptake And any affect they one the was lacking sort the of CMS. of wondering not might in reimbursement to your exactly in conversations just IV

they for then question. around Angus take comments provided Thanks everybody's the in look, their the speaking, rule response lot Q&A what was. CMS and I second mean, Its question the final out came the I'll first. a of

think there's trying end stuck the the rock at what a of costs, incentivize and a of ruling. ultimately do bit to at to they're of out out comments that but here. innovation, like the certainly between think a there a limit they time were I the answers obviously managing gave day, trying it to place costs hard feels core of lot same was the came I and they a And part what

final So they that's they letter the affiliated our the you out document Q&A and with at rule. provided -- if comment put look

our they specific you see comments. against of So comments can put each

And that do your that We're we there, think in we're so going do public there all and there exercises Again, real about world first work to all the that. to innovative question. out to we've prove the how domain. remind we excited got an mentioned, out continue need product to that's here. And all data out Stuart the

discontinued forward? policy ESA affect if any going uptake, And as noticed has through well just wondering monitoring the being I was on Triferic that just the CMS. that

From is us. Angus. can don't view, I of -- reduce you we're I usage I a initiative hopefully again, associated obviously ESA, warning our complications. show what have for data benefit. financial trying has mean, yield with real that a here mean, to I financial think point But black what also if the ESAs box world a it's obviously of cardiovascular is which

So I benefits reducing the could has think ESA, monitoring think ultimately financial regardless we benefit and usage policy, Triferic. that of the of CMS clinical

that impact look to from at So continue health pharmacoeconomic outcome Triferic we're overall perspective. look and and clinical, going of to economic a the at

up, on launches question focused as considering. concentrates are wanted just I And sense. coming makes if Triferic for just base to as considering marketing think final that the the revenues that a ongoing. any case the should about business. stable, sure go was be how Okay, wondering provide we that. that you concentrates have that things It I on could be these or those we of guidance just still seems pretty the just was trending forward, been lot And business, make for a but should to

It's Angus, again.

year, So comparison last and Obviously, it the strong stable. was if so, fairly slightly that international at or the QX unfavorable. pretty quarters of has largely year-over-year to had in look We and QX three markets. sales last you is due been the

to in said America. markets, partner our little my that. I Latin continue remarks, we're volumes, pullback of prepared As our But we'll some working in with worked in particularly we've had with of of and some those get a bit back to partner seen a and do those

the of to quarter concentrates margin signed business. the of example price lot as profile think continue focus But saw with the try of to third a one that on we we've I we I in think new is obviously globally, X.X that our a and expand U.S. and things work, to with types to And business you improve and going improve a a within Triferic. we're we continue work we'll that's valuable year So margins. the more to to in business and the of look grow here both on think DaVita contract increase, the got

like would time. I there this the no showing Mr. conference am turn are Paul. Stuart I to questions to at back further now

for to afternoon. Thanks Okay. once this us joining all again

Ladies today's have and your for day. a you this participation and call. wonderful conference gentlemen, Thank concludes

You disconnect. all may