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Rockwell Medical (RMTI)

Participants
Claudia Styslinger Investor Relations
Russell Ellison President and Chief Executive Officer
Russell Skibsted Executive Vice President, Chief Financial Officer and Chief Business Officer
Marc Hoffman Chief Medical Officer
Brandon Folkes Cantor Fitzgerald
Call transcript
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Operator

Thank you for standing by and welcome to the Rockwell Medical First Quarter 2021 Results Call. At this time all participants are in a listen-only mode. After speaker presentation there will be a question and answer session. [Operator Instructions] [Operator Instructions] Please be advised that today's conference maybe recorded. [Operator Instructions] I would now like to hand the conference over to your host Claudia Styslinger, Investor Relations.

Claudia Styslinger

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

Russell Ellison

execute this the and for we our afternoon for since where you us. first has been call, strategy, last thank it only you of Good detailed to believe joining accelerate with growth about XXXX, FPC continue quarter in In against potential six reputation from call earnings short. will of the keep we our Since our we business high we weeks our disease states. solid multiple strategy from by and strength are platform growth dialysis to therapeutics generated the combining our foundation, what

Our the to concentrates of the dialysis business, base continue sales steadily of is which perform.

this us second are the to of foundation grow. and a haemodialysis and supplier in million solid on We revenue annual in United generates business States about the gives concentrates $XX which largest

the of in lower compared fourth in the to market XXXX. U.S. Triferic sales Our quarter dialysis for net were QX

three sales which implementation. QX quarter-over-quarter. in preparation clinics While date. made to under changes. discontinue had contracted patients actively that the increased, three new of The strongest of dialysis to due purchases net flat acquisition or to We of large clinics period where QX each was went Triferic number was with use number clinics organizations, XXXX customers independent our contract for management of treating

all in and delays were there occur not did implementation three repurchases However, cases in in QX.

patients ramping was launched on QX of February. and AVNU, in in putting Triferic see of commercially We up from are as expecting formulation our some begin to Triferic reorders clinics therapy. IV these they

it difficult dialysis the session. found expect we before, a labor IV As at of said delivering requirement we have to clinics slow each slower accommodate have a as infusion uptake

will We and clinics data and are we utilize the anemia to and savings. customers going cost stable later payment forward present expect hemoglobin, environment believe of conscious we make seeing we challenges reduced as our interventions other capitated are with exploring this to in options year. dialysis, faced Triferic drugs adoption increase second to the have cost to resulting we of the half. progress alternative in methods more results, readout The continue IV Triferic have real-world administration that with actively Despite the positive

are remaining program, FPC infusion FPC are To to products result, I'll we critical foundational expect pivot many and for more helping that catalyst given patient data and growth which and technology. future medical population, pharmaceutical the evidence X.X for are as on a our platform large potentially growth loyal doses we comments has These a FPC the have generated states customers based as haemodialysis than on efficacy a in extensive my developing to Our Rockwell been success. our date our home very real-world that be the will safety outside of Today, are data by us million focus major generate frail dialysis. opportunity. disease

iron select Our is significant unmet patients A deficiency for receiving anemia at home. effective safe infusion development our therapies and decision strategic treatment to home area as need is a priority one. intravenous for a

dialysis the make setting. of use patients. intensify. I for Based you're patients safety in to population the given home As the years my development with trying seen the to the experience fortunate more dialysis database we're we de-risks events. development, molecule that on with and date treated from in plus its home, these product believe our in in treating believe drug trials, ideal experience XX Based for efficacy significantly of and FPC setting. reliable about a clinical infusion FPC candidate in your its million serious excellent on have FPC studying. in being use the will safety to of its data, effectiveness you're the need a we more than the learn believe We efficacy safety we're it and safety no patient an assessing Typically are With of doses have patients more that large and safety clinical to

we iron underlying Many And products suffer clinic no the believe and setting. regarding infusion reduced. there's trials. health infusions actively safety the that with as favorable can It's deficiency, case the know home anemia, older cause diseases policies the a the safely not patient is FPC FPC is issue disease of setting. Likewise, have matter home in unexpected that infusion efficacy, diseases. a be increasing we setting. to and chronic from This Both an or of insurers is the another patient's home high expensive accelerating of home given presence hospital and deficiency home are for to demonstrate is is home give home the long risk iron therapies use setting the a in growing not in effect Cost So is that The the respect infusion in where reimbursement ability to much improve of influenced patient bleeding. This the the treatments driven IVR other is particularly by with to Medicare growth saving driver anemia. significantly de-risked are setting infusion. of long safety and to inflammation. for growth substantially X private give most therapies incidence you the in condition by of state, means that the dose by very intravenous being in the number and technologies compared Phase of drugs number for for new as requiring of allow associated a an groups the that given infusion of efficacy

prescribing generally infusions practices This vicious forms up required, or for for infusion deficiency. of for the the iron frequent difficult IV under-diagnosis visits medicines under-treatment for Importantly, infusion can most physicians do cycle who of results home of a in are not patients. and parental and set iron nutrients be office have home other

can iron immune of increased potential the including note the than fusion at patients higher be is be X% deficiency Contrast this heart iron business example, than in point. of dialysis. population, any Home iron failure. consequences home of much serious for deficiency remain parental anemia have half it's portfolio dialysis nutrition For an deficient. has the important with iron to if less fatigue, and a risk which of where And patients to risk high also at compromise, margin deficiency and our the product extreme function left untreated, FPC population,

and infusion product insurance, commercial FPC reimbursement. As for meet that has and would The we be IVA B a dialysis, for eligible for diverse, pricing. and the home and if future infusion product, separate for from believe Medicare private means that then FPC be will treatment that and our application proposed submission. setting and well may This current that for Part reimbursement, criteria allowing home we positioned the new for submit confirmed drug a public for products based FDA would the approved the be would private public distinct appropriate XXX(b)(X) which

product the the $XXX appropriate we estimate to in of U.S. this With and the market the up in secure considering addressable suitability ability opportunity area, to million. total pricing of

outcome We expect thereafter Phase to randomized have be first trial This start to FDA X later well-controlled the our clinical pending with shortly of trial trial will a to look year. and this product progress. the meeting successful you the With I'll our for treatment updating I patients the forward call a of that we overview. Russell financial Skibsted for brief Russell? home in iron turn infusion. anemia any undergoing as to pre-IND

Russell Skibsted

combining the our continue outside dialysis to the laid from dialysis. out therapeutics business platform by growth the also strength multiple of strategy potential generated Russell. the high to reputation growth quarter our states first in mentioned and in accelerate solid foundation, Thanks, from disease we we of against That's FPC execute with

prior of increase comprised abnormalities, year quarter back concentrates increase first is semblance of is of in in approximately XXXX. to in quarter but the of than toward the perform. to about higher Total roughly prior the and of Triferic approximately $XXX,XXX heading the business than of of Net $XXX,XXX the $XXX,XXX dialysis were are first concentrates from from continued an which which steadily first sales of XXXX, of a to XXXX, sales XXXX. primarily seemed Triferic haemodialysis fourth We the Our Triferic sales revenue the quarter or the quarter lower versus believe normalcy. quarter from be both drop $XX.X about in XX% were due the which and COVID-XX million the

the mentioned in reasons approximate prior. just for the decrease from earlier, in Triferic quarter Russell sales a it the $XXX,XXX was However,

as to we strong progressing believe position the million, quarter XXXX puts of to investments are of of slower Our $XX.X expected, which with approximately and international albeit end due drive progressing equivalents a strategic initiatives. nonetheless. a our in cash, cash We first programs bit us COVID-XX, but company's

early QX received In burn closing large issues payments. cash burn remarks. Our our continue burn burn April. which the be specifically from one the QX by Overall, our XXXX, higher due I'll quarter and aggregate. in XXXX. to annualized receipt in back some cash product was normally call sales with in cash in customers, was related our affected was for XXXX our line payments it now to to subsequently expectations in of timing the further our is to than cash expect Russell one-time and In reimbursements was Ellison we will his lower first turn for for of

Russell Ellison

Thanks, Russell.

These business our well develop with IDA. and Triferic development platform. the working questions. the milestones home advance the development to the in over has line for XXXX patients infusion exciting in include to as and turn coming and Our expected FPC commercial as opportunities dialysis our of for for I'll We're near-term to progress FPC XXXX. operator alongside opportunity clinical near-term expansion company up global multiple milestones

Operator

first comes Folkes Thank you. Our from Brandon Fitzgerald. Cantor question line [Operator of Instructions] of the

Your line is open.

Brandon Folkes

for just me. taking my three thanks maybe questions, from Hi,

update just Firstly, you now infusion, factors – Phase and the So any much. the on the we the And other talk Thanks during NYU of the be in quarter? home can cost quite it through then meeting, the pre-IND there. interesting quarter optimization lastly, X from study concentrates taking business. just just promising any be focusing anything the share Secondly, getting last received would feedback else on? you that beginning between is feedback can should any you

Russell Ellison

Medical your will Financial Chief one. and Thanks your a first two our address Marc. our Russell Skibsted, questions to lot, Hoffman, Chief address Brandon. I'll have Go last Officer, Marc ahead then Officer,

Marc Hoffman

you for you. Brandon. Thank Thank do. your Will question,

confirmation us the study program. of you then and Phase I if our with question together we to assuming of package then And to X just want are progress home infusion between and what right meet so in will the and X IND repeat, was are correct, Phase the So, in presence is study the we'll our study? the pre-IND putting plan

the Okay. that? regarding the questions And [indiscernible] Your Medicine any data. full Care Triferic. positive to NYU out results manuscript of clinical second – with the NYU The was producing we're and the possibility independently in the on the by NYU And was Journal. to data. NYU of produced question published a data showed data explore second was Critical economic as the the in of reaching very benefits for process a implementation both The and on

Russell Skibsted

putting taking then Brandon And taking program concentrate out get kicked the the where about early your we and we – the at and all we're business. it other a going fee, the to now. just off the most We've the can processes figure calling literally out process, bang look data look stages a can to some the together, we're respect terms the look right that for question on doing. buck getting exactly of in at that where of what get at of efficiencies. data those efficiencies whiteboard We're with the so we're It's the

that. may to first of the already even which of able potentially see little bit facilities One be additional revenue areas, into just to year, looking either in quarter think, bring we've revenue the started the we've and is ways I impact manufacture, half generating a the at this first of already the to some done this year, we've – we on biggest

additional may next to our on transportation book of trucks the But the more So think, for a we – things, some I'll we're maybe little on identify you with movement, some hopefully, to side trying of of revenue call. able additional be quickest I the close. there empty getting detail, that to update we're the create routes that getting as with able some working where see the reps cut haven't we've efficiency analysis that to And software we can close but way that we're that to on or finalized to putting efficient also we if we're our well. are some traveling the some been yet, implementing together some optimize

questions. next that, update on any we'll with you to more have other you but have hopefully, unless call, So our

Brandon Folkes

Great. you Thank much. very

Russell Skibsted

Thanks, Brandon.

Operator

pass to to Ellison you. Thank back remarks. call I closing would like now the for Russell

Russell Ellison

Thank you today joining have good and all a for us evening.

Operator

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

disconnect. may now You