RMTI - Earnings call transcript Q4 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Rockwell Medical 2018 Q4 and Year End Results Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to turn the call over to Judy DiClemente from In-Site Communications. Ma'am, please begin.

Judy DiClemente

Thank you, Mark. Fourth Earnings Medical's Call. Rockwell to Quarter Results XXXX Welcome the of firm This DiClemente Communications, Investor is Judy In-Site Relations Medical. for Rockwell With Stuart are Officer; Chief today's and Officer on Financial Medical. Executive Smith, and Paul, Rockwell of Chief Angus me President call

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

terms success and our duration reimbursement including to success Rockwell and for of include: planned opportunity plans; plans other Triferic; relating and and Rockwell's resources; us While add-on including these timing the under NDA the this IV renegotiate different. efforts which subject call the which believes forward-looking reliance and Actual business. Rockwell current any uncertainties date those TDAPA; to for are set concentrates upon other reasonable, various undue and such to and of could to based uncertainty. statements inherent potential subject capital are liquidity should risks for in Triferic; to not filings, Triferic, statements, statements and of Triferic and and of products, subject IV which Rockwell timing and status about economic on our These estimates without materially on Rockwell's submission statements control placed based forward-looking working be reimbursement the and on limitation, and pricing products; forward-looking of expected be of are existing capital are results market planned beyond our commercialization and Dialysate our to for SEC IV many are timing eligibility uncertainties, available Risks Triferic information change. the and assumptions, forth are of

rebroadcast Rockwell call publicly events these and accessed be we on recorded reflect Relation's XX-Q, Forward-looking for results. disclaim subject in report call, numerous reports, www.rockwellmed.com. most on and that the on recent webpage. forward-looking to our conference on can the and in Stuart? link to this could be our and This same results our statements on is factors Paul. to www.sec.gov include call call can anticipated cause located factors intent a over These XX-K are described by through statements any will Medical actual from forward-looking on This updated website including Form statements circumstances. session. the turn are is update XX, website periodic to question-and-answer the SEC's at webpage. call on be our At also accessed Form Stuart to date differ quarterly Investor The like as conference the followed would made to subsequent call audio this available The this or XXXX of which CEO, Rockwell's March at made of being I time, are our a

Stuart Paul

that medical patients. opportunity clinical This among Thank accomplished we've everyone. short need unmet very great you, product call our morning, global time a toward Judy, a exciting a you our dialysis and deal Rockwell for very time, In addresses today. We is good advancing joining a large for commercial Medical. Thank for our goals. see portfolio a and

long-term strengthen team sector, and for to we country year. have financing team now franchise. international launch with Triferic, Peru execution for to Let property the approval business for We a our IV our a in renal assembled, received top-notch developed the of me With start additional balance in-licensed We global support We strategic and accomplishments key sheet. completed pharmaceutical quarter this of a with fourth commercialization January guide some million first launch we $XX of experience Triferic management our efforts. support the and first marketing, Triferic XXXX. of to rights of plan the our assembled operations our the this intellectual general for in

our launching partners partners the XXXX, and Japan; of key second XXXX; NDA for geographies, of our for first of Triferic including the of formulation growing Triferic and of our quarter Dialysate Triferic, existing For in global the concentrates and milestones the and in new also continuing quarter XXXX; IV in the filing FDA formulation in Triferic development business. the profitability the through Europe identifying U.S., second improving include: XXX(b)X portfolio, second with

Let with various hemodialysis in Dialysis delivery potential to insufficient to therapy its current FDA-approved first and iron iron why the management the inflammation. to hemoglobin frankly, ESAs, improve iron has so we're and maintain to patients. anemia for marrow, IV reasons, in Triferic replacement me leads to due the The in compromising indicated patients. treatments system ability reticuloendothelial range. iron the only target start iron-deficient dialysis and excited of and patients anemia care in for is bone blood maintain loss patients, iron This hemodialysis and of of patient's thereby limitations. during hemodialysis hemoglobin standard become to of sequestration Triferic about deficiency including in

of effort blood that use significant reticuloendothelial primarily years, may many the evolved and system, iron in production is such by clinical proportion and products substantial in up are remain in IV ESA taken A in of red off-label generation. unavailable the liver These administered practice IV iron liver. cell iron reduce the are Over costs. to hemoglobin therefore, and the amounts for U.S. usage using in several has IV last clinics the an

iron has KDIGO or average skyrocketed levels hemodialysis above key recommended ferritin industry the patients result, levels by a and load in As including KDOQI. guidelines,

an of Studies have to action, reactions, increase here levels its improve through hypersensitivity nonalcoholic significantly patients ferritin and high to of linked guidelines. in risks in these hemodialysis infections, reduce been events liver introduced unique the patients, anemia In mechanism abroad. related has U.S. in fact, cardiovascular in significant in and than physiologic and the to U.S. potential ferritin the more patients including standard fatty XX% above have the have levels patients complications. adverse that hemodialysis the care for of the and Triferic, disease,

with Dialysate excited who we're constitutes unlike a liver iron sales of More hemoglobin of unique and at placebo why therefore, a later. the for million a of the sizable for has was opportunity launch safe nine it defined or ESAs, production it the blood Triferic. presents XX% anemia accounts the placebo is launch. the of other in more the the therapies, patients two year. and we without iron alone, the placebo nine In And uptake in the that iron we of XXX,XXX are XXXX, believe we in-center more in buildup with arm in potential for bypasses differentiator showed patients, and opportunity XX% the in no maintenance. binds hemodialysis hemodialysis cell over traditional products tissues. which or IV product a maintained offering discussed significant market more traditional months. the irons, patients Triferic liver the compared than Triferic compared unique the offers its products, iron I dialysis levels. transferrin, Furthermore, demonstrated $X months, about Triferic. that and as bone XX% application segment, the ESA there our patients and also Today, the is current replacement immediately billion. to than This portfolio. drug PRIME for So, This better to second And marrow large physiologic ESA reduction enthusiasm this XX% details for U.S. XX a earlier. among Triferic Triferic a with IV disease Triferic formulations: expect we they mechanism ferritin file And Dialysate our compared study, to importantly, And top patients upcoming in attractive use believe during less study the have to IV IV each the ESA more red gentle hypo-responder ESA-sparing U.S. to compared transports we reduction an us. arm, action, and with increase hyporesponsive and pharmacoeconomic And hemoglobin the findings approach for which And clinics. throughout receive These at clinical to In IV key is than level offer support quarter our so for outcomes because and very treatments renal U.S. study. iron organs of and IV end-stage are we on in a Triferic Triferic. adoption new Triferic PRIME

profile believe potential offer we in with Triferic to profile. a the and of addition standard existing proven Triferic so proposition. its to action, clinics for compared care pharmacoeconomic unique better the of has management, anemia safety strong mechanism a risk-benefit And offers hemodialysis And

We And about Triferic. formulations will result, and advance dialysis work multiple trialed as to think extremely that a unique on related data offer to to publication clinics continue clinics and have Triferic, alternatives to to Triferic a with patients. available economic harness health have that outcomes we're excited strategy we we

loop is system Each without formulation, of treatment central clinic then The with transported rooms have during Dialysate dialysis the for which the The solution through presentation XXXX. at launch Triferic. dialysis Triferic be clinics administered that ampoule at patients a presentation. packet liquid at quarter intend also clinic, Triferic, packet liquid patients. bicarbonate the we Triferic packet that Triferic central XX mixed the single to the powder loop can bicarbonate patients in enough initial a of a both all we to And second receive going bicarbonate are through can presentation both and that prevalent in system. Our U.S. is Dialysate to call liquid a provides presentations in We bedside, the of the powder the meaning through solution presentation consists water Dialysate powder a of of patient the

can we their through formulation, blood line be the call treatment. during patients Triferic, next which Our to directly administered IV dialysis

IV and year, and build of will an of of first Triferic Triferic believe launch Triferic launch on for the launch. are executives file our infrastructure second NDA to to promised for put our assembled we've at next upcoming for we'll groundwork our track will the work IV the quarter during approval with of been activities broad if Dialysate in we expect would experience, the building undertaking for we've Triferic, and We outstanding execute half an the team To the which approved. us rollout be be our an for We preparing XXXX, XXXX decision and instrumental potential of during these hard success, lay XXXX. industry

needed a we to also specifically activities last to and this spending the building launch opinion a team Triferic significant market Triferic Dialysate several commercial for targeted a already goods. that advisory educate and prepare of for with over boards and as the for the key We've months. conduct and leaders progressed process advantages. its including been accounts research, well fresh activities finished time of and plan launch. in and Our pricing key of amount have the are production medical There We're launch, engaging development franchise, execution Triferic, build around for field the is preparing awareness to commercial in several as

advantages beginning XXXX several next will to for Triferic that fully their the providers be that of years potential time due to practices. We course use has management the we've the commercial for medical the educate compelling to and product. the education Triferic standard us discussed, that some expect to it existing but focus changing will about over anemia clinics the process take care converting we of on of of expect become around Our the delivering

Dialysate launch the approach be at multipronged. specifically, Looking Triferic more will our

expect ramp and the make to to by sales, onboard, launch, XX have Triferic market. the Dialysate plan this launch have and broadly, to First, we we of medium-sized, to up medical organizations the to approximately the that program. approximately XX% end of centers a At the participated marketing, And we to dialysis small professionals U.S. year. plan people selected expect focus of trial independent we team Triferic dialysis target on more in that of

dialysis would Triferic the expect seeing conversion centers those time, For that for the cycle, are several first months. we

product XXXX. Triferic of the better Importantly, during the with and XXXX the in to our support be team we're experience launch customers building will gain IV valuable positioned and

several means special analyses Triferic under Triferic, new dosage Now, Dialysate design, IV the to formulation our the unique From protocol that and studies. our assessment and a FDA, the a and the separate form of trial FDA has clinical therefore, requires of developed IV which offer a let with and the the statistical routed standpoint, action endpoints same turn mechanism views it portfolio, me which next as a NDA. Triferic to FDA administration, benefits. in Triferic IV Triferic was additional as pre-agreed regulatory

the show bioequivalence to equivalence iron and rather FDA other be comparing than that As acceptable transferrin-bound part we IV Dialysate Triferic. were PK In Dialysate year, acceptable Triferic that running SPA, Triferic words, between Triferic. are In Triferic. for and Dialysate be parameters to and IV an of NDA agreed would if Triferic safety total of IV bioequivalence PK review our IV additional of the approach for efficacy Triferic demonstrated would by with iron able last completed trials, studies

FDA of was for in And anticipated in this NDA. the IV PDUFA NDA on that We the the presenting study of study in No offered from year, and March submit the were material for raised meeting. NDA date on data a potential during during received meeting, agreed the our of an issues FDA meeting the XXXX. XXth. to which the studies of filing approval our the during benefits the June the other equivalent pre-NDA FDA excited first submission We based the adequate Dallas be quarter plan potential in by equivalence from held will second Conference We're and to the additional about at Dialysis XXXX, the data with regarding we Annual with that this an half pre-NDA Triferic. and study feedback

for or eligible, payment XX protocols. are if Triferic view. while for Triferic approved centers And approval, XXXX, some the CMS adoption of more would U.S. make to dialysis as of offers Triferic believe others point to which clinics the convenience the to separate add-on IV a based another separate for patients. eligible months. administering We their on dialysis on clinics of IV adjustment, may anemia formulation, financial prefer new after recently that certain be option or a view announced And we for believe solution, likely it better from IV are remove therapies will dialysate January second, for a Triferic TDAPA, CMS to and First, the workflow beginning to subject help payments XXXX appealing transitional approved drug provides hurdles in for Triferic reimbursement period in X,

for Dialysate liquid dialysis since Japan, dialysis that than markets opportunity and Triferic utilize clinics is that international And must for predominantly in use Triferic monitors. Europe, Triferic. is mixed use, many Dialysate compatible we the believe monitors market dry And with bicarbonate Finally, not global such it's prior IV as these large larger to that China be of bicarbonate reason the this simply cartridges. with

reimbursement, the TDAPA by of time payment On final around topic deal experts clarity gain last of a to was November we've rule great consulting the and published that with spent CMS.

We be it Dialysate reimbursed launch we disclosed, by pricing even bundle for will product will providers, the previously the plan be of of Triferic market to achieve that margins the Triferic dialysis not we're meaning second finalizing a our determine attractive patients. reach to Triferic. Dialysate expect and we optimal within Medicare and for the product research broad quarter, for separately. making rate reimbursed pricing sales can base while the As commercial believe in affordable we bundle, within Accordingly, Dialysate

needs to potential clinicians it Triferic shift get require believe anemia most. hands and the the we management has and the importantly, to for and dialysis, patients More of it the who paradigm into

this a enthusiasm pharmacoeconomic managing to the and offers Triferic, that As population. KOLs advantages anemia the about great within leading paradigm and there we of of Triferic shift advantages the deal in potential begun is educate about clinical

a drug, Public Federal by Act X, as previously, approved for XXX a for for available qualify submitted mentioned a be dialysis outside and the plus as a be we drugs. eligible XXXX IV as service, must published injectable Triferic after under of to The ESRD therefore, Triferic, CMS. J-code TDAPA for and reimbursement CMS, Drug drugs believe application well to be by period or and IV renal will CMS Food November prospective system bundle criteria, According the can approval XXX as these new of January eligible or Health which renal we for all reimbursement review designated for meet ASP have a Act, Service that a that that in X%. dialysis Cosmetic was TDAPA final and be new by eligible includes believe Section to at to the the that payment commercially We are be of states Medicare subject XXXX approved CMS will of rule FDA for threshold Section months, product HCPCS TDAPA. by For XX

currently IV in after for the would TDAPA CMS regulatory are of payments, We Triferic us bundle. separate positioning with and into to it with X-year engaging window a optimally consultants go assist which likely

Turning United Biopharmaceuticals. to partner the Triferic working development States, China, of we've in made significant specifically our with the Wanbang progress, outside

one that other, We the are X which completed trial the in XXXX, CFDA early as have enrollment. coming has studies is by of which conducted expect clinical studies, and completed of PK in these being be will through likely months. part and the studies plan These was approved we that halfway initiated approximately dosing the

have CFDA. And these approval regulatory and meeting, by approval partner, of potential that late would from with outcome positive to with for Wanbang, XXXX. completion collaboration a Following later of to a meeting studies the with we sometime our a this pre-NDA our assuming in file we partner, expect equivalent expect year, the

IV the in believe process also While significant previously, our therapeutics, by certain China, agreement. I said a of And in opportunity we Triferic, to partner working since rights covers is to the license online largely Dialysate that has our generation. we are market adding Triferic is on agreement bicarbonate Triferic IV as and Triferic original new

We $XX approval patients. China for in and expect payments, IV opportunity, sales-based And milestone up the pathway later the that China. with price Triferic to provides also current Wanbang this of with XXX,XXX an regulatory the help will royalty. China hemodialysis double-digit transfer beginning year of of large and in the agreement a plus meeting attractive our million approval regulatory CFDA market with with for more Triferic clarify than represents

Moving international in to XXXX. we activities, Triferic approval Canada for on expect other regulatory to in our file for

realize we hemodialysis provides in Canada. expect to XX,XXX the our of in Latin there international us approval are for January and on a launch our that also excited Peru, We're of partner Triferic with first of economics an to approval this this opportunity agreement address distribution further patients sales We're and we Our of with QX looking the in population in in majority Dialysate year year, Triferic our next in Peru. of America in Chile. to than forward awaiting more expansion to received

partners unpartnered In identify to in XXX,XXX Japan. are priorities regions, hemodialysis are and Triferic IV Europe, international patients. for most Europe our forward, there notably Going than key more

In than in hemodialysis the patient discussions with a more XXX,XXX. for with Triferic. EMA license XXXX, intend would this reached study study attractive additional market parameters At do until During we Phase a III active a approval for linked could have provide pharmacoeconomic on data. agreement support primary which also we population an an study of The for Europe. Europe. include endpoint Japan to agreement a not we initiate to a regarding Japan, regulatory another is the in important with we're reached ESA-sparing, to time, partner

upfront us. We mix payable expect agreements, these milestone payments to of completed, would that and royalties include partnership if a payments,

of the $XX.X me Triferic, that turn Rockwell's for accounts substantially see While which supply improve opportunities is the industry, million including let and We're of portfolio. our Baxter much both opportunities DaVita, these today to the all therapeutic development say, at the lie give entree of business, the to us significant generated with companies relationships and of to U.S. directed of now concentrate key supplies exploring believe of around questions revenues for now ahead both concentrate were attention and also we now should the we I we and to QX opportunities XXXX. currently efficiencies We significant Last in -- economics amounts, further Calcitriol. concentrates to in regarding the new operational future players reach quarter, customers, internationally. the in well, achieve in of dialysis there business also a to number

is States, capacity share we assessment me market Let have at inventory consideration, best demand. that we reserving meaningful the manufacturing the review launching this with Simply that at of full see concluded And to in a a for And U.S. opportunity costs, Calcitriol interest the of sense. including that Calcitriol after in against a profit margin States completed margin not this in have Calcitriol approximately pricing, -- and revenues we as an in United careful accordingly, the $XXX,XXX. remaining the Rockwell time, put, do our generate time. not we're profit makes of United

financials. forward, our now to we market about developing our Angus will our conditions evaluate we're continue to in partner Angus? over Chinese Smith, in I turn that the CFO, with ongoing and market. call engaged review Going discussions Calcitriol launching will and to

Angus Smith

Thank you, Stuart.

relate increase increase $XXX,XXX for gross management sales increase XXXX. fourth Gross both loss a well consulting fees reporting me by due by were international quarter million million million fourth an was million results Let of for XXXX. and Baxter Selling, was the an XXst, for in costs XXXX. quarter increases XXXX the to quarter for $X.X compared the fourth use million $X.XX to quarter $X.X was to Gross in compared the write-down in general compared XXXX. quarter compensation Triferic, XXXX. legal share million and of expenses of of offset quarter to to were due were of the was activities million quarter development diluted fourth XXXX. to to million as and Ajay expenses, licensed development partially fourth fourth compared and compared of fourth as expenses. XXXX per of loss the master Gupta increase this the for consisting used fourth reviewing related of million. quarter With of $X.XX zero quarter The expenses our capital million by primarily and the Dr. of call $XX.X XXXX the expenses $XX.X $X.X distribution was revenue the in fourth from XXXX and fourth a for quarter for to trials of the decrease quarter impacted million sales operating or profit of sale quarter and billed investments higher sales Sales Research labor of basic for due and $X.X share related XXst, Triferic the Research $XX.X and in negatively start as had and fourth of to the into and I turn XXXX. $X fourth fourth the -- DaVita. costs. for services the product for basic inventory product of financial and to of in increased XXXX for with quarter in $X $X.X and The of Net Baxter Cash reserves with profit also The compared increase lower inventory and of in in XXXX expenses year-over-year that, offset $X.X quarter equivalents insurance agreement company inventory related XXXX. and diluted $X.X total and million $X.X the primarily The in sales was XXXX. And fourth the $X.X and of largely December or and December XXXX. administrative was $X IT testing to liquidity entered a fees, million. variable the Calcitriol. to this expenses profit quarter per the of available fourth improvement as product of gross partially quarter and $XXX,XXX for for distribution with the category to compared was October million higher in LLC loss of volume. of The development expense net offset fourth expenses, cash higher $XX.X fourth higher Stuart. due recruiting volume, of $XX.X to $XX.X by primarily in of for cash reserve of XXXX, the by agreement lower was quarter included to to Charak million fourth for Research quarter in increase Working acquired costs million million lower and XXXX the million product stock-based annual to now million, were in clinical XXXX bonus $X.X in of sales XXXX XXXX, will of back in

Stuart Paul

Thank you, Angus.

reiterate of Board scientific of board unmet Rockwell is management team, Triferic patients world. Directors today a a me Let and advisory has address around that and needs the forward and the that take to hemodialysis capable ready medical

in prepare the to our go-forward, to add to and space on tirelessly care worked have potential for has the shift shareholders. We the paradigm value Triferic, business long-term hemodialysis a therapeutic plan for the commercialization of which we believe

questions. open to now call will We Operator? the

Operator

And first Instructions] question David our line Bouchey [Operator the of comes of IFS Securities. from

now Your is open. line

David Bouchey

got keep that a other and minimum guys. try to to get I'll I'll chance try but you. to so a lot ask. I morning, keep of Thank questions, Good a them my people --

want about of worth you the the as the that Calcitriol It The talked were that $XX And company part was margins of from going D. to marketed or range in there the $XX a just had management to had to of thing sales terms be active do decision. I in were in the get being lowest more. fact a its vitamin is cost, advantages first dose lowest XX% U.S. of be that clarification that of peak million for And million might the kind in I Calcitriol estimated know previous

looking two tell not those I'm anymore? me to you so changed you So, numbers for Calcitriol can launch the want what management styles, comparison that a has between don't in but

Angus Smith

you prevailing great from business based into done customers. capabilities. the dive perspective. a What the question. we've We've manufacturing sense make We've our good market Angus. say it's a prices assessed market And the it I'll financial feedback question. Yes, obviously, Calcitriol conversations doesn't many It's that. whole is Thank we've what costs. product in on cases, morning. launch is received with David. for are, had for to manufacturing like concluded Hi, than And our a deep from And standpoint, like that lot of a that we've lower a a a

So dose think adjusted work on for get be that it to just Calcitriol equivalency comparing market as are we we've of to to products we standpoint. doesn't again, a the lot us need the that an well. where done And similar margin and of from price a

mind, in we're in point, the not to launch U.S. So, deciding with this at that it

As we'll we're market continue potential dialogue U.S., with in Calcitriol also market Stuart mentioned, the in the Calcitriol about our the evaluate to for Wanbang, for China, partner continuing and there.

David Bouchey

little believe, on Chinese be did And I clarification Okay. you Triferic for just a say milestone for available Stuart, approval would the China? next in partnership. that the

Stuart Paul

Correct.

David Bouchey

Okay.

Stuart Paul

Stuart. It's

you. speak to partner, great forward So Pharmaceuticals. Wanbang with We're moving our with

imminent upon position Wanbang So potential CFDA, complete we'll be to file it the next China year. based -- discussion to months. good in studies the clinical in file in a the is is coming And in that the would think with later there we

China. relevant to a XXXX, would Those late approval conservative see the be on milestone So toward basis, hopefully, a in dates. we're looking potential

David Bouchey

for is the about do ESA-sparing. is question IV next in endpoint be and approval in order to my have to you European study the the And Okay. get Union to Triferic, primary going that

comparative in was XXX trial PRIME trial, scope So, with a you and the randomized anticipate size patients? little a be to than this more to trial similar which do

Angus Smith

for It's Angus. question. Yes, the David, thanks

needs around we've EMA had still about we to what the Europe think it's discussions look I are with like dose. endpoint the ESA and in --

the that formal stage and We we've of yet, drafted haven't protocols things to gotten nature. where

partnership we will I we as EU that say a choose our will in ultimately think a those as And have partner studies advance the discussions. think how become whoever clear all get more I designed. in

at I this and those So be will think trials kind stage, size. would scope to exactly comment premature it of be designed on and how the

David Bouchey

much kind estimate how trial of is Well, cost? do getting you what have that I'm for an at might

Angus Smith

and we saw probably there's with to that guidance haven't to as on help could obviously, be, like. fair trial a would we that stage. ballpark, this probably the for to do cost Again, of Yes. exactly it's said draft protocol I what a work which sense And look bit partners before, that study get out given what preliminary at comment

David Bouchey

more And Can sales right. particular to DaVita the be coming that change to contractual dialysate GranuFlo upon might in DaVita? be in of some expect your there to what might speculation in might there a there's terms in of from that see been to you -- to a comment CitraPure. switch supplies, year All your you

Stuart Paul

think with on become of great have for product to very levels the not at we're but for give guidance a dialysis standard this sets portfolio entire care. stage, market, I think States well actual opportunities DaVita is paradigm beautifully We improvements. with in as so expanding going that continue discussions to and part around pricing we're Triferic other potential to We the focus and United we're We will in to CitraPure and well forward. shift going the nice table Well, logistics a say with specific CitraPure. look providers CitraPure of for as our going we think the and works DaVita concentrate as at the sales address margin

team experience So, a working I just around that's very type DaVita prior environments the discussions up that the with terms and say successful win-win a those from DaVita, with going and vector would and we with have assembled, And scenario much are setting we're well, in of product that protocols. on. we've future company of think,

David Bouchey

to of address you the lastly, powder address you would concerns there Triferic as let the continuing Are Triferic the some Triferic? well version launch. sell launch any liquid cannibalization? of Or that? about anticipate how about potential IV version after concerns And version Excellent. me you the Do as

Stuart Paul

than those at that with not for the certain presentation with packet. for and more they as of work think prefer. liquid around the target place But rule going of Dave, and account the central And preferences. forward. and would little segmentation with bit prelaunch patients the turn we are that and that version powder might to ends We more products anything three. out a niche It we going think we have out even certainly, interesting be interaction the model point, use but up we gravitate quite will say which this as there's just very accounts, bit a -- certainly, that one to a loop have we're accounts to perspectives all actively account our other, for a I there a certain different basis, of on market desire would find that

at And want can the for we you And administer really least workflow with in so place, the to right have all with the patient there's a economics center those that three. because bedside. interference the IV model going think, is great be and for to

going though, I mix. is part IV down be the Triferic dominant really of our think road, the to

David Bouchey

Okay.

to So time that's then? evolve that's going something over

Stuart Paul

as the in standard a understand make come say. there's just Yes, there's differences I action a the care, don't happen. us to here just the lot of excitement. do tent begin that of the nephrologists have under I to think to and that news educating I work would mechanistic The front KOLs underestimate of and general, we they challenge really -- current in the good And is between of lot and

So been care place need something standard in year industry that fixed It setting change overnight, some to on been that going not current for somewhat a time. And base. we to this that is take build of standard quite right? care that's of is in a an has really to happens

for see portfolio. very So improvement this, it will take but uptake and time, and and the we'll focused -- on continuous we're think

David Bouchey

Okay.

version investors call happen? of Now, IV offer won't I Triferic that have not. could separate me impact had the J-codes you or are to you version your on assurances some the of get in Triferic of concerns some beliefs Can investors? that that, terms the dialysate with whether What call

Stuart Paul

Okay.

know question I that's of a investors there. lot big out So the of a

by right? me There look, guarantees, let So start no guarantees. there's just saying, are no

the However, however, legal with and for are IV entire reviewed firms our top also a experienced we plans Triferic. CMS. the for portfolio IV times. We've have in CMS practice who We've packet tier reviewed and with with We the met forward powder going several reimbursement our ampoule, deeply reimbursement with reviewed consultants, and expert More new of and FDA our as CMS. for I to Triferic health XXX reimbursement specifically, to therapeutics present obviously, post earlier, new I TDAPA regulatory and approved it care strategy reimbursement pharmaceuticals say -- said that and would regulatory arenas, helped to align they've applies XXXX. us IV X/X the designation approved compliance under applies

drug, as separate commercially You the we meet And CMS. discussed have out we key -- for for for have be -- get a the all need to CMS. this We've available, approved submitted by must believe apply J-code. laid criteria to a you HCPCS newly with

J-codes. we're So, had entities in therapeutics and separate that of have are and also aware other success establishing similar -- molecular had

the entire people, And guarantees a our so but team picture, good basis. advisory on this affect we with can at now separate have we experience you no are when lot the and the J-code, There everything pretty on in to feel right backdrop doing we're of we group the about look extended of and that world, okay?

David Bouchey

Okay. CMS Can you with? you've say who specifically dealing been in

Stuart Paul

-- I'd get into not of individuals. rather rather Well, really specific names

David Bouchey

of timeline support ask Triferic? I the to last version the promise, you, just market have with for might and care do is you begin this I oncology in want question, to IV the you access of Well a Okay. when mind

Stuart Paul

great All question. right. Well,

expanding right concentrate those But all are peritoneal But total IV the back think, I and as such going Triferic in we right? TPN, well on hemodialysis. opportunities oncology. focusing the -- franchise in efforts for improving to Triferic would near-term to We're I evaluate now, say. continue believe and dialysate as business, are indications, parenteral now, those and investments outside burner, things nutrition; dialysis; of we're obviously, hemodialysis as all into investments there new our and/or

David Bouchey

And Thanks. the All now. queue right. Thank of out you. I'll get

Stuart Paul

much. talk to Great with so you, Dave. Thanks

Operator

of private from a line next McNamara, our question comes the investor. Robert And

now open. line is Your

Unidentified Analyst

the Hi, up questions, you're at what's risk you the market the in come separate terms was having David's I of on reward the pricing at could. the if both And to just the and you could pricing about just reward? products no And follow time, want at the J-code comments are said IV. I formulation looking some there risk you as scenario, multiple same the there's since When in how estimates you us potentially difference? of on powder gentlemen. looking guarantee to the ascertain well sort of as how ballpark pack for give do some if also

Angus Smith

in. Stuart Angus. start Robert. It's Thanks, can and chime I'll

think potential shift to is anemia way that therapeutic get we availability said; I Stuart -- in to of from clinical most the patients important market. thing as and benefit paradigm it needs the Triferic is on in a the here population. think is the this This that has the therapeutic. the a really managed And that this

for color IV that's of primary continuing mentioned, the to end those a From a at for motive to as like Stuart pricing little that's complete, the going what the well as day, give to So is dialysate formulation pricing we'll on therapeutics. conduct research, more as able standpoint the once the our look the we are formulation. here. And pricing both be

Stuart Paul

of just medical drive really add of primary that comments. for year, of space. the our in really one to XXXX. treatment -- what terms and shifting good don't to education would I the idea focus would in I is, to really the to and amount KOLs the I the for just Angus, potential the modality dialysis entire this to providers we get out work underestimate -- mechanism, is paradigm there in That's of the the points the begin in and general,

dialysate on page, who same that's we needed hands the experts into have So, it's we've number it underestimate It's in get and are said, shift and do. we up already. all of and in strategy are portfolio. to time the the a Angus really of they patients we and I of into out into once build actually CMS. the we clinicians is that mean, of speed and now of as get approved, start really approved, TDAPA model the quite and if our significant and the and And years components torn want work. move amount then and come to with it, to and with forward to do, all discussions continue work all market time there, version gears requirements with a with TDAPA perspective. our active been shelf the This Working so where most. model the get I product best to out of with the we on IV it's lot that's align don't the for to a of literally to with reimbursement, for the here CMS, go in this, to

would say. I what that's So

Unidentified Analyst

form powder forward in to And the the the pack you've that, could anticipate How versus the the in said presenting initially, you're your with a what on as at market you terms product you've of us little quarter you DaVita are as version give the to you in as launching terms talked so larger been in powder taking concentrate, with a corporations when looking in expectations also, IV? as move and better the launch? if would when are the customers, initial follow-up of the you Calcitriol you second discussions, And launch timing occurring?

Stuart Paul

great No, Yes. question.

and to forth, would tell those non-disruptive larger basically would in protocols file. large the protocols, organizations say very in-center therapeutics say here, can with the sophisticated that that significant would we and protocols, to way. like let's and there and say, complement I of again, launching in-center is I Triferic you about what DaVitas just world franchise a a dialysis ones, so disturbing is products others So and a some premium I approved those on workflow, the outlining have of very not respect

in the way to work start single about that and Triferic I dialysis environment really with the that I like partner as for known into is obviously. said, and my great DaVita Rockwell, Gambro, DaVita. have DaVita Dialysate into -- the discussions the myself, the from partners And segments past. around broader so a other team medium my with KOLs And let's and out think mind, get with our size we player is market Baxter,

side to discussion. the we have a very all we're DaVita of continuously partner, the strategic fact very the think as I table them house. open, I committed on partner at the a we can concentrate and very is with good a view Rockwell, that based that think on DaVita

the us ensure segments it the So, accordingly. we I of into market will marketplace, for do right think the going right the and allow forward, our products of the with that map products parts to pair the segmentation

marketing focus our we team really got a hit been of marketing and that's lot that ensure to we've on So correctly. this done research

Unidentified Analyst

are So, would motivated that to considering DaVita is focused in clinics forth, profitability? you'd at and market for and a there the for that be with of that into initial and to that very the others say least a so few addition best, it launch in fair powder you be the considering Fresenius focused Is practice commercial mixing very different protocols are clearly, since XX% on and at larger protocols account the XX% ARA launch, as target their then your are renal, practices own that applying have well? dialysis looking product that fair the to or XXXX XX% estimate U.S. at on for that powder initial maybe more also,

Stuart Paul

market of at and I there. No, essentially, chain XX% the about medium-sized at at independent of XX% single the look you look looking space, when say players Yes. would you market the the

that say as sales on continue roll and build up well our terms and the helping them give field our to management liaisons, those of iceberg. with would is experience, launch anemia time and -- in around dialysate to strength capabilities medical the build paradigms Triferic. the will on clinically science out our target medically, Dialysate scientifically, we time in which the tip target speed are I get of yes, as to So, segments teams, of consist as field experience, who spend to

classic this you our a see market opportunity golden out from potentially, So sooner that view, start of do You a to right? want point is look market marketing and paradigm-shifting is this really later. at in the than therapy, to a with well to get view

to important us. So those very target segments are

of this launch. the they're the program segmentation our that of place trial insignificant, water of in of be We the sites market in in is begin -- first earlier, the as have I as of the targeting. great all put terms course, to the mentioned will of that been a year and well also And initially, to then certainly involved all that on in launch toe XX% think not

Unidentified Analyst

Okay. And quick Stuart, the provide is any talk follow-up on pharmacoeconomic I able what's agreement? us have having to One, briefly, difficult two the Gupta conference to of appears end to tell and or the as beginning year, the call, there. update patents then PTO patents website, my into valid out were to when numbers it's are U.S. you of guided very which the then back last still powder? this last market from one Because in had that or licensed appreciate data goes I'll the year, questions. part other that are find I patent actually time. And generating all out that the you you having on of about go data program get data follow-up queue. sample the it

Angus Smith

It's All right. for Yes. Thank you the question. Angus.

mix the no there the structured a a the On rate, the there's to if we all the if repeat are the our long an valid so question? patents And our period exhibit XX-K, as in It's be question. numbers Well, and that world. rate, way lower the patents. going license, to valid and issued exhibit is second are so a is as there ship and actually there patents can patent will in all that the there pending of that to be second patents would filing And we're question of And and so Charak agreement and of the time the exhibit you royalty agreement be list. issued a XX-K. long is again, disclosed and a as higher here, around where royalty for issued -- then will -- and

Unidentified Analyst

that related we had probably to question should had sample mentioned data the now. second Stuart have The program was by

Stuart Paul

publication is No, of potentially, as move the And it certain forward around still -- presentations fair conference, it frankly, congress data. in basically our our calling in we And take forward. going to getting venues getting are through process out and process the the in We're and it. of question. Yes. we're we our plan arms still

kind but come more just of when to data. arms came and getting in on the still, around the clocked program we that I So our that still been door, we've

And to so come there. more

Unidentified Analyst

And I'm quick. sorry, real but

timing can have the program, -- sample when So that as a to that there data? you're on is we still

Stuart Paul

together certain to I the right said, year. the final And would we getting the might elements have as strategy there. in it publication We're say come, of of data into stages what prime start that now. the of midpart I our pulling again, is objective

that So, be would we might of year, timely until anticipated see approval. not Triferic part beginning standpoint IV those of next some the of our publications the from but

the it. So looking way we're at that's

Operator

and I'll ladies that's the the Medical remarks. questions back to turn And closing we all team for today. for time have now call gentlemen, Rockwell the

Stuart Paul

touch be you the happy joining Thank Okay. all We're next on you were with And you that wish for you us to all Thanks able and very us today. be well. we'll call. again. in with

Operator

conclude the today's in may does This you participating a have conference. you and thank Ladies for all and program, Everyone, gentlemen, wonderful disconnect. day.

Rockwell Medical (RMTI) 14 Mar 192018 Q4 Earnings call transcript