RMTI Rockwell Medical

Jason Finkelstein SVP, Argot Partners, IR
Russell Ellison President & CEO
Russell Skibsted EVP, CFO & Chief Business Officer
Marc Hoffman Chief Medical Officer
Raghuram Selvaraju H.C. Wainwright
Call transcript
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Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Third Quarter 2021 Results Conference Call.

As a reminder, this conference is being recorded. At this time, I would like to introduce Jason Finkelstein, Investor Relations. Please go ahead.

Jason Finkelstein

Good afternoon. of the Finkelstein for Relations Jason Medical. Rockwell is Argot Investor Partners, representative This

Rockwell today's and Marketing, Russell for Medical Russell from Hoffman, Sales and me Joining on and Dr. Officer. Senior and President, Financial Marc Executive Q&A. Vice Chief Vice of Business Ellison, Medical call available Chief Officer; Chole, Executive will and Officer; be Skibsted, Chief Chief Officer Tim President Dr. are President

call Ellison. are remind Form we XX-K the meaning on forward-looking will quarterly filed reports and our with statements filed detail could by reports to the our these greater discussed statements XX, that as in or Except Factors I expressed our in statements forward-looking laws, report statements available light differ cause as such in revise actual Executive in that obligation conference This Relations our actual filed like required our future Relations limited which being Chief with materially same that like Before forward-looking of expectations are of opinions of outcomes or and events. Investor reflect report to the of web today. differ. website to accessed the by call the as only not the to, information uncertainties was Investor Medical's Securities to webcast section. to filed would results call today; Please rebroadcast annual Medical's to those update forward-looking law, also within everyone any these call and Russell for we turn XXXX; results disclaim on about page. on that be begin, Federal SEC. implied periodic statements including, in be audio Form to contain but the was note forward-looking be from can new statements risks web or that or conference on will identified specifically Russell? cause types on this Officer, and Rockwell At I on this subject would Dr. company SEC, can that in the and the time, conference is accessed can our subsequent Rockwell periodic recorded March This These over page. XX-Q

Russell Ellison

in of products, third the quarter both you, growth Driven outside us. In dialysis. versus third strong business, increase dialysis quarter quarter year. Jason. reputation you dialysis in an to joining XXXX, of sales the last the of our returning platform and advancement by in a net concentrates our foundation Thank of on we of afternoon, development and Good with XXXX third strategy of for the second thank FPC which progress improvements continued our Rockwell solid quarter, delivered with saw combined the and

Our U.S. concentrates expanding We're and internationally. in both the the business in exploring, to continues perform of business domestically geographically to this expectations, process our

with are achieved IND development an We home. therapy pleased for the for patients milestone submission infusion important to very an have FPC at receiving of

a II the submitted hemoglobin. other regimens X-dosing to the to gain our FPC we proposal. deficiency on pre-IND feedback for clinical placebo, of June, FDA in recall of one versus Phase expected and of evaluate the meeting randomized, may proposed you As is study The for anemia iron request placebo-controlled trial to treatment maintenance

requiring We of to regular infusion or on our the Home clearance have homes. an X. infusions treated their in service about model that IND anticipation allows of preliminary of the patients medications study is December a in own be initiated comfort therapy activities of

home XXXX. infusion is anemia. deficiency to with a health incidence hemodialysis. growing more X.X of patients infusion, This suffer associated are iron home referring chronic patient home we For million care high therapies and than a groups segment from of as clarity, when we diseases rapidly that refer with requiring are large, to not of Many

that XX% all for therapy causing nutrition and patterns infusion it's of them result with risk, on iron example, to serious home patients For function poor heart extreme treatment deficiency to be home immune iron XX% and estimated fatigue can parenteral inadequate health deficient. patients Current such as anemia, failure. in are suffer can

these infusion about safe way therapy the to accomplishments for may premature more suggest our the treat begin it's believe of an is now market in iron both to home benefit infusion of deficiency, patients market concentrates. the and recent to home development I'll estimate that as a up they dialysis $XXX business trial. and we IND our We'll million. While clears, our to U.S. to market in our our up which receiving turn business, comprised opportunity say after existing and in pertain FPC effective have Triferic patient XXX,XXX to may from which addressable opportunity revenue populations, from clinical and we to

reduction and relevant will are San progress real MDO, from and management in efforts community. of real-world more And in flat many believe dialysis in prior analysis coming on gain continue or quarter Triferic's important begin hemodialysis. arsenal program we payer Triferic strengthen integration treatment regulatory the the Society source which to iron for international results the Dialysis and of Triferic as for We in clinics, American a presented caregivers, Nephrology Our commercialization the multiple Kidney respective iron for approval third the versus total strong XXXX of a not the results the revenue at sales quarter. California. foremost part Mid-Sized medical years, as clinics further of dialysis but the into publications evidence results are Organization, utilization are anemia countries revenue part and our innovative their usage. findings can from was that an second products. confirmed Triferic of IV the an their in outside position patients in be the We value essentially at that FPC patients only of for Week U.S. in The accommodating new recently observational Diego, partners believe to evidence models countries. in of and Results protocols of

bundled One Triferic contract disclosed, competitors. by of In but of medical with ASP, AVNU or commercial stabilized headwinds was heavily in adoption for reimbursement accelerate and with in largely to an losses dialysis expire, to Triferic States. the revenue in efforts agreements quarter. our securing the these shift their U.S. headwinds, occur us to we is from to the offset sold Changes selling to and these were as have evidence-based. Triferic continues in slow our we and customers competitive offerings to a continued price practice new our market. for Triferic face our allowed acquired and average And able experience clinics improved and are with which capitated previously United and Triferic into dialysis strategy are decided space the

initiative, our part of States. find efforts adjusted to As commercial to within a are partner sales the our and this United we've expand marketing sales and efforts working

vertically effectively We expect of strength dialysis a for-profit commercial that in and more alignment organizations with provider consolidated partner competitive compete suppliers. integrated large bring needed environment the will to

hemodialysis. for believe to a and the is on safe, We in therapeutics patients Triferic maintenance innovative important of hemoglobin continue efficacious,

facing spending turn the continued environment. commercialization challenges financial call be I'll to as for we we acknowledge are the Skibsted will to are With we in the in overview. of future committed we intentional that, Russell a Triferic While Russell? present the commercial brief the U.S., about

Russell Skibsted

drive our the with million, ended cash and expectations We which line believe us company's with our equivalents Russell. we XXXX, of approximately Thanks, initiatives. of was third in keeps in position $XX.X strategic quarter to cash, and a investments which

sales the approximately and quarter second the $XXX,XXX year. which year. the quarter, $XX.X concentrates see during million sales quarter quarter third quarter $XX of concentrate and the of COVID Triferic million internationally. this million During the Total in starting the Net versus about in both were flat sales this impact uptick roughly of million higher of as expected domestically increased $XX.X sales hemodialysis the which approximately prior with for the was sales subsides XXXX. of the to in quarter, million our the third and to was $X.X XXXX of third $XXX,XXX in quarter, in activities second of of the compared of operating was sales, $X.X to and quarter. quarter, $XX.X second the were $XXX,XXX compared year cash Triferic were the which quarter We're XXXX to third the used in quarter for net of compared the million second in Net higher about

timing due to normal than seasonal and higher both was cash factors. quarter third Our

the efforts, some use Our cost reflecting seasonal expectations, in and was the of some our of the related quarter beginning third line the costs with in of impact of initiatives. COVID to efficiency timing, our our impact savings nonrecurring of cash

that and more share chain call supply our the to related and we for analysis Russell? pursue. turn our now mid- expect logistics of to now his closing of I'll to I this most initiatives remarks. back are first intend short, have to Russell prioritizing the completed have the the to year. after We and Ellison projects about longer-term

Russell Ellison

patients development-stage concentrate considering hospitalized our the from I'll acute deficiency to in dialysis products, patients failure. belief which to have Medical. steady and of to our joining ahead and that by with want Medical unlock for seen over FPC includes thank revenue I'll conclude I our Thanks, I today of us saying shareholders Russell. Thank biopharmaceutical potential of home for Rockwell We're in your patience to Rockwell company. to heart alongside opportunity our operator for working a this you. for program call with our revenue-generating stable the products. develop much a anemia the and company exciting the efforts very questions. consider for with infusion opportunities in you now large the your sales we our interest turn of base iron line business, the business Thank value dialysis advance and the


And Ram question with Instructions] Selvaraju Wainwright. H.C. first from comes [Operator our

Your open. line is now

Raghuram Selvaraju

Can you hear me?

Russell Ellison

can Ram. you, hear we Yes,

Raghuram Selvaraju


that you other months? muted likely the the coming initiatives if talk bit you about evolution firstly, you clinical see ongoing little given How carried the Do out, a I development the all was pandemic clinical be course of activities? in had could the and are anticipate that on So effectively wondering becoming impact do uncertainties has development pandemic; context the clinical the programs. those in which you impacting development of of the envisaged to well-documented surrounding your impact see the

Russell Ellison

the a on turn ironically, Medical a take in But use constraints medication as home we're their health this setting. home And of get is question, embarking then the the to their the anemia clinic of I'll at our part have, to really Hoffman, That's up setting, it great They And stab Pyrophosphate iron first in program to first don't of basically routine Marc the And Citrate at the aid over part ironically, infusion deficiency development bringing infusion this get care the you it the treat into of to home of set is Ram. Officer. a home. Chief people and Ferric visits trial. management.

doing extent, in ironically, even home waning though is largely to remarkably So unaffected. is pandemic a the COVID trial pandemic, infusion the some

that this doing that want we're that to a that? do on fortunate Marc, trial we're it more So you context. -- we're little in doing comment

Marc Hoffman

Russell. Sure,

just agree infusion perceived I to So or actually everything of a what therapy. that, is step into go study further this one, benefits home having is visit hospital not has just the a to stated and take number the would receive absolutely say clinic and the with of pandemic this is that one Russell

benefit. that we things of downstream see So a the as that's one

is other patients the more remote clinical in there's given study the collection entry design, where where and research to patient management. are being of data number type of fine-tune data a the for pandemic, are build the coming and seen actually and opportunity The touch organizations it's this and less on we that

we're many this actually So ways. from benefiting in

Russell Ellison

say heart failure. an the you're really an much mortality impact overall a I treatments do you of we FDA, of they can would on show that tractable. failure not requirements the add put or out I require really program with short-term on particularly a more not for impact with meetings impact. requirements trials for And But face-to-face bad. -- at been. call, in They about just the is one have for makes failure FDA by to before don't And to is pandemic phone least trial, we that lack -- heart required the want large, communications their acute confirm But the start And guidance that heart correspondent. that anymore, and don't have would FDA by we you with short-term get which first, happen reduced discussion time to haven't trial. the little

used little actually it really that's quite has impact now. I'm I going overall be to certainly So what know been, sitting with down different to a I different. and And the don't think to Washington been is them. but

really it. COVID will we'll to to the patients, be of we be really heart there. by that trial, that with to even when impact time on than we that's congestive So failure, are have we And now more hospitalized hospitals. the woods do the And start of out be hopefully, respect in so

Raghuram Selvaraju

helpful, answer. very very nuanced That's

is bifurcated wondering, which the I conduct of and indications shift you a a which a effectively this Or on moving in context supporting product the programs offering? takes continue development available Secondly, where as your envisageable commercial the programs, in strategy responsibility seeking expect you partner a going situation the scenario envisaging development are with you there in forward as both well to is of commercially aspects, the a coming was partner, offerings? where for is maybe in and clinical situation partner be of you're the clinical product in but these it development to potentially

Russell Ellison

on home Triferic been That's sorry big very that cetera. the basically, a But the when this that. United we data, in to the point, yes, as States. Phase But on we're the in It can't depends indication. Post III a failure good development or been And call commercialization we II commercialization about II et as for you say good U.S. of would two I'm Triferic have and don't we completed I have the anticipating, have really certainly I we've to We're know of could clear have right this program not how about Phase -- infusion. Phase our in partnering that is would at weren't at option Ram, focused really be partnering what now, be, programs. point. the heart point, referring today

Raghuram Selvaraju

and lastly, in And ex U.S., European Okay. announcements interest developments, have of Triferic ex quite Triferic, markets. those of international relevance in and involved prior a AVNU number clearly there's

any So announcement a developments anticipating with frame mature? commercial be kinetics et catalysts. noteworthy are what international a on I from was And those whether have potentially might accrue, potentially additional what regions, Pac partnership -- color value-driving Far wondering East, or are timing cetera, if the deal are those standpoint. with if time those there LATAM, you specific whether which might those Asia you And might launch some around any or front,

you that, If comment could please. on

Russell Ellison

want A RX great point. address [ph], do you to this?

Russell Skibsted

question. Sure. Sure. I a would it's there can take question. that. Thanks, Ram. Thanks say big for I the -- that

his clinical But from earlier schedule the China, have Russell They're in better largest trial better to the both in the and see the on reimbursement on world. it's for data comments, would of actually, expect and underway. with the U.S., and market is which we with U.S., plans. India dialysis in countries We of programs with think -- are would so their interesting As China, the China. outside way some markets they're mentioned in prepared instance, because we the in than

we're XXXX. I launch But of looking waiting that at be that think through think the the would half on And from timing this probably provided word to from that I first there, year. before goes the first probably Jeil, submission would our regulatory And authorities partner, submitted authority. the we're for it hear -- of NDA get from earlier our Korean we're I the think okay would see, something, going the product then think they launch. I terms in process when the

-- that ready launch launch. trying doing in the get to preparation I for behind right of we're know of lot work anticipation we're scenes, that So a now

our keep we'll fingers So crossed.

Raghuram Selvaraju

you. Thank


Q&A concludes This session. the

to the Ellison Now for I'll closing line back Dr. turn remarks.

Russell Ellison

this all much. for us for quarter. the continued for and our thank forward on efforts I Well, you company and want you this joining next I in successful. and very be with you support to call call, just And to our your Thanks thank look next to faith


This Thank for concludes today's participating. conference call. you

now disconnect. may You