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Rockwell Medical (RMTI)

Participants
Claudia Styslinger IR, Argo Partners
Russell Ellison President and CEO
Tim Chole VP, Marketing
Marc Hoffman CMO
Russell Skibsted EVP, CFO and Chief Business Officer
Brandon Folkes Cantor Fitzgerald
Call transcript
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Operator

Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Fourth Quarter and Full Year 2020 Results Call. At this time all participant lines are in listen-only mode. [Operator Instructions] After the presentation there will be a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded. At this time, I would like to introduce Claudia Styslinger, Investor Relations. ahead. go Please

Claudia Styslinger

is Relations This of Partners, Argo Good for Claudia Rockwell Investor representative Medical. the afternoon. Styslinger

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

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

Russell Ellison

faced for joining important you Thank I'm pandemic. year companies XXXX most And COVID-XX up. the our afternoon. an stepped of Like proud Good we for team was challenges us. around the us. during world, how

And demand and people we protocols. customers strict met without Our our created followed interruption.

lives to, shift We marked we patients have our sheltering company. depended the place. also in trajectory significant have on it. option of serve in of XXXX The not do the a

more and today shareholders We we of there The remarks take action clear into I hard by Rockwell's margin first a unrealized look to enthusiasm the Medical the dedicated I out we lay brought future. are practical the for one I are and whom in Rockwell Rockwell following board evolve a diversified at as broadly of The Medical that value. to higher board to consultant mid-XXXX company. believe company. a plan was the company was year ago. my were to not our to want terms purpose want our with in expectations address near-term, to the share even for same that is my also share

but it, Let well believe positively that platform, next our One key technology foundational me in We iron I a not broad or generation beyond. FPC as was had we assets. you two range call can through pyrophosphate parenteral citrate, process. only impact walk of ferric the patients, dialysis,

approval how value, when assets. could two concentrate CEO and ignored business. decade, the I business. was had showing growth, so joined people reimbursed on has or over by The can generate and outcomes adoption reinvigorate that board, the challenge has depend whose centered had asset a care. an because but except this these we by was patient been our under that value the versus for accelerated concentrates. grade market the long-term health large post other began fixed dependent costs We when was lives in Triferic, FDA Medicare lower type and/or drive was already XXX,XXX from Since would I that We became the largely the reimagine required best the already it, in was a dialysis necessary still market pretty past business, is Triferic approval. the our the The be current determined on it since and data been bundle of XXXX, The we improved generational how share standard foundational we unlock on data, evidence launched strong and last squarely not to of future for of April economic the unrealized Triferic discussion us

three primary or for accelerated shareholder higher thereby growth, have we thought drivers I As pillars margin improve and achieving value.

we The which data. in the needed first meant of Triferic generate increasing is to U.S., sales

The find respective the meant for partners needed in launched efforts is help we getting Triferic appropriate and get to and approved countries. second their set their sales which Triferic to them internationally, with

educator that Skibsted, whom driven more from space. FPC I future there Senior deficiency in landscapes. and benefit high I'm will the therapeutics nurse improve support these executive more generated we the Dr. company, management iron and growth and from by driven salary the reimbursement public myself, pretty and management We Chief to We've key patient Data company the most added from to companies later favorable and and Officer are believe critical expertise. our and analysis. appointments in expertise, effective And string future including commercialization Directors. to It Russell medical and of can our we needed board, a patients right where straightforward us level for and optimize our with our to FPC of people confident of commercial from partnership to and achieve medically, the a both and The drug regulatory strengthened potential was key end, platform, scientifically Third, Tim our small and hearing President support our reputation execution providing team that disease Marketing, and were and support requires signed in the iron accelerate agreements Board of Korea. commercial Chole, me foundation experience strategy adoption reimbursement NYU our Triferic progress. dialysis, with and both our strengthen for which needed platform, development we with team Hoffman of Medical become platform, experience Marc well more accelerate changes to regulatory required our already we Vice experience. with relevant as be significant the in approvals. if states established by success the dialysis. needed both finance made We FPC an company. of data we support including to treatment our development commercial cap CFO indications right greater data. of our and growth to the will Sales was with that you us strategy recently strength of combining navigate our clinical dialysis where hires need with to our growth, This To published multiple We this our completed CBO, that clear clinical, in India call. solid to we be next which are in determine as the right data anemia business, Future and deficiency, evolution

of of indications in year. When of we the the approval. we We've the process technology, think biggest areas indications identified distinct identify, clinical focus. and impact Our will have not Rockwell's to increase a later we in as about of China one up X having required it to the trial has also two clinical from review We've our increase first efficiency, partner this new expect to believe also business to three sales. start think initiated study the ground only concentrate Phase which for FPC but ways business, our of begun these

products. two Triferic concentrates business our First, and and our which dialysis includes market

deficiency pipeline. for Second, third, the heart in our priority in top the for this acute our our FPC start patients clinical setting. the Currently And advancement infusion I'll of pipeline. anemia home iron with development failure business. is program in hospitalized dialysis

that Medical I is the is think States. Rockwell hemodialysis in concentrates the United of it supplier underappreciated largest second

facilities, hemodialysis under to capabilities concentrates manufacturer three logistics in the well throughout GMP these United We States. products of have as the as most of delivering dialysis in of clinics in core the

gives and This to centers. Our based us the about on on $XX foundation million than to solid dialysis is annual service grow. XX-years in revenue reputation of business generates a which more kidney

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is adoption continue to generate in increasing in the showing for clinics protocols. benefits Triferic to strategy Our world real data of

are hemodialysis. Triferic study and innovations the with plan practices also anticipated change We future that use to in medical to

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use faster, will in meaningful infusion acute failure. deliver track of we fewer FPC suffering. and with care resulting We hospital that recover the second-half trial stays our heart would treatment XXXX. and home patients reduction FPC for X heart pipeline, human potentially cardiac in the exploring In on be hospitalized rapidly patients Phase could energetics. readmissions, to in which This improve XX-day our the of the believe are bioavailable We of health initiate costs shorter FPC iron to a and effect help are

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additional to Russell our our towards of a I'm and the FPC finally going Skibsted driving to Tim, new platform Mark, tomorrow. discuss and unlock this base, your company. our proprietary and value innovations have are I our We build now vision the on and turn over to our then color opportunities, HIF-PHI it long. who to dialysis further update. for leveraging products to and the core to belief can to thank efforts will before that give business, call Tim? by FPC financial to then provide patience every And important I our yield your fortifying of in revenue you conviction

Tim Chole

Russell. Thanks,

be the and of We've of in provide the U.S. major one in our grown dialysis built the and XXXX, around dialysis Medical and of sell customers we dialysis focus have create In crisis. business, our reputation be of our market, improve months the the and strong worst concentrates manufacture I excellence customer pandemic our strategies world. to as suppliers We on the would proud the were serving the maintain the concentrates to we like that to will two the level in update business. will of and highest of concentrates service. storm COVID-XX interruptions one service, established maintaining a supply profitability. reliable the most U.S., suppliers with in on presence on no with Rockwell efficiencies First, implementing best-in-class with winter performance the the an Texas was and through customer the

the focus in growing Triferic. Our space on continues primary of to the commercial dialysis be adoption

is mentioned, capitated price Trifericin we novel market distinct adoption steady providers. into product under the and pressure. a a dialysis extreme a clinics. we As And Triferic advantages model for have sell independent among U.S. seen with dialysis reimbursement and with Russell Nevertheless, growth patients

new of entered During clinics progress quarter approximately patients to X,XXX. This dialysis of We fourth again the the fourth to urban impact be agreements decisions COVID significant clinics, continues adopting engagement we XX. burden Nevertheless, good ways to particularly areas, results somewhat as cases virtual lagged expectations, to number into incremental bringing leverage made such the means surge changes, XX to number in in caused and experienced total contracted force clinics, front changing some in decision new behind overall The the many increased those which about or Dialysate. in a the making treatment quarter get with of field Triferic purchase our delay creative tools makers. on of find for due the the continued quarter, cases The proved Triferic part protocols. in products contract to any them of additional with for for pandemic. to

protocols world gathering on of world Triferic, optimizing a with this learning showing focused evidence outcomes. amount through been economic anemia clinics. health from leveraging our real user data management We real about have We and tremendous the

strength advocates. customers potential push our evaluation program successful has that the straight with in value the potential a We be proven to to connecting adopting by approach. and customers Triferic, cases move nephrology to able help and this accomplish purchase On analysis clinics the and to this were by users to utilizing of of for evidence, are impact calculate bypass financial a Triferic many toolkit, contracts experts

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like our our new Triferic IV FDA portfolio, an Triferic. update to a AVNU management products it anemia platform of joins for formulation as I'd adult on administration and disease. haemodialysis Triferic Triferic AVNU only intravenous with provide and Next, is extension to line and dependent designed Dialysate unique of kidney Triferic by Triferic AVNU, patients in the enhances direct Triferic indication hemoglobin is replace approved with patients Triferic an patients a chronic iron be providing regardless greater maintain options with used, our where Triferic target our clinics that's is about delivery haemodialysis of infusion more Dialysate in being XX% expanding for Triferic Triferic not access an dry can With This technology using the cases in the segment. as it's the appropriate to product AVNU, to clinic bicarbonate bicarbonate administered of market and of represents option. mode is clinics. IV by the administration

focus in have In has agreements, dry Triferic AVNU those technology. where who the Triferic we clinics customers, will outreach solid working unable through use adopt within we launch to expressed market using Triferic the been the past, been and the it. existing that bicarbonate of to to in to contract have organizations interest independent but use been quarter on started in for with had due The the prepare second dialysis to organizations, Triferic to Triferic of Our introducing AVNU to promotional QX. opportunity their it commercial add continued have cases so have AVNU technology bicarbonate XXXX, of

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access As allows new it a be until Triferic, an a physicians us labor less is to segment extension line treatment. identify methods to opportunity Adoption intensive of for the limited, can market with individualize provides product to administration. and we expected

respect will a progress. help in and make the breakthrough and Dialysate the for to for opportunities have may Triferic open U.S. Triferic doors important in the an the approved preferred U.S., more Triferic find our also continue of as overall to the believe U.S., portfolio, global we where adoption to However, increases to development an help outside open the be important AVNU the to commercialization we Triferic IV With us of drug to of commercialized form AVNU it for and Triferic, formulation. increase partners of potential It's us

Korea, country. agreement China for announced Triferic new applications Canada. license patient has in X Phase recently drug its our partner registration submission drug enrolled We its we Health AVNU by Triferic in As Jeil that its in have and who new in our And with Pharma continues Dialysate filed review South trial. a signed first

process now over Our Marc. authorities, partner been COVID. turn with Pharma Sun call through regulatory delayed which to in Indian I'll the India is the working has by the

Marc Hoffman

you, Thank Tim.

of which new haemodialysis consistent Triferic First, inhibitor, prolyl entirely I'd disease the in physiologic provide of plan change renal and anemia hypoxia-inducible of or to are patients. HIF-PHI, the a management the expected of like treatment touch an in introduction end agents, to We the management in to haemodialysis. upon anemia anticipated HIF-PHI hydroxylase to stage anemia class position strategically factor alongside

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the successful trial clinical year. meeting, second-half the Following the we in of will initiate this

strategy in with clarity with development as therapeutic heart we energetics acute patients seek heart cardiac indication to on For a our intend for proposed acute pipeline to FPC, FDA failure, improve meet to deficiency. failure hospitalized iron our

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Skibsted financial overview. Russell turn for Russell? the a I'll call for Next,

Russell Skibsted

Thanks Marc.

sales concentrates were Net more $XX.X was roughly was which for haemodialysis XXXX. to million were net the than $XX.X compared were approximately XXXX to XXXX. for Triferic approximately sales about million, Our million in $X.X the to XXXX. of $XXX,XXX $X.X in year, approximately sales compared year, million flat Net which

with initiatives year we Russell, I manufacturing ended After visiting sales related XXXX, process Baxter. that a ground mentioned concentrate equivalents year, international manufacturing included opportunities in focus Triferic position are grow of $XXX,XXX us cash, of convinced also deferred were approximately opportunities also cash our believe to $XX.X Russell to million our to to became efficient. which XXXX puts up facilities, more make revenue each year with a began We the each million, described. included For previously strategic increasingly I business. each that our operations a It transportation deferred believe earlier on this investments Marc there the our to of agreement there and and approximately $X Tim, partnerships. in business. revenue we both good related the review and approximately of of

now overall the closing We which projects to Russell? remarks. his I'll to profitability identify to have back hope for turn these ways of the this you year. update launched improve I call to later Russell on core operations, Ellison,

Russell Ellison

Russell. Thanks,

call platform. we coming expansion reinvigorating development near-term multiple has FPC XXXX the include commercial outlined company as well global XXXX. Triferic, today our of the that our development our Our up business. and and our milestones in on activities milestones reimagining a clinical These of was company expected for and anticipated year in XXXX, as progress

scientifically and the and year, execution value. our toward continued for driven drivers. expect progress in year is and this increase now we strong next has to become clinically our made to growth a strategy plan been company mode, I drive remainder and as growth of execute key new Our against progress

over the questions. operator the turn line to I'll for Now,

Operator

first [Operator comes line up question Instructions] Cantor Brandon Folkes with Our from Fitzgerald.

Brandon Folkes

Could little it elaborate do if can you're margin, congratulations levers off. Thanks And, Hi. of me. be pull just pull you obviously bit taking quarter. you concentrates on sort the progress to just meaningful Maybe for quite of what revenue business a there. able the amount and on that to my have in good from the three questions you on

approval obviously, think the since this data, then, many feedback together Secondly, just uptake? the maybe elaborate just stand drive alone a of out for of market? NYU? of can segments now. you any the And generating far. the one, you. you being expect roxadustat, that agency think key of questions roxadustat uptake of at the Or of lot maybe of publication will certain you've data to those had Or pieces in And right do should lastly you uptake? do so that to of of infiltrate this think can segments terms you're say we can drive first with NYU that to you as market then sort the on in Thank around you study hospital data you What you expect guess I just this

Russell Ellison

Well, you have three questions there.

that. you for thank very much So,

take your Thanks. two over Russell. other And Russell? off On the we concentrates questions. this then turn to issue, I'll can maybe

Russell Skibsted

question, the for Sure. Thanks Brandon.

mentioned, I margins. we bottom there top of the visited line and can since do help As I facilities. some things I struck was, And me think to definitely is joining line each what the just both

we're handling, costs. the So what to really can this to the trying where materials we're embarking process ground a see we're margins increase optimize supply doing logistics, we lower really where entire up upon analysis, is and chain,

give now, to But we're I I have find be on completed of a to little increase side going will it's bring able feeling to working be different until it efficient, And guidance we've addition a ways good think ways we -- we to the efficiencies just is through really to looking more that right can to looking the at to it making too more top-line. able but that, the other there. potentially to in have early assessment we're at that. say then some wait

our So, we manufacturing bandwidth our available logistics. have and within within facilities

through optimistic some that pretty can turns any, actually we're other can which if products ways the we to can top-line to other feel wait Again, that until make I assessment, but we've in looking we gone about have make that on. other through we'll it. what, So generate at manufacture there out be we

Russell Ellison

want Marc, question? Thanks, data address do Russell. And you to the

Marc Hoffman

to I could the Brandon, this so answer too. happy can [Indiscernible]. just question, be I’d ask I Sure, in you repeat

Brandon Folkes

maybe impressive should pieces So, do looks think some pieces pretty of as to-date. on think of should drive data, of you we data NYU to expect just, we on data, the the one it see And standalone drive to this will the the you're get approval uptake Or you've this you. market really will year over hospital of data segments that of market? Thank are the [Indiscernible]. segments certain that roxa within will think run? those then collectively the think that any feedback do many you And uptake? to May of one, Or that Do surface. coming waiting in received going of you data uptake? that study that for drive secondly,

Marc Hoffman

you for Okay, Thank the great. question.

regard this of long-term which as that I real evidence with series of the we that we've NYU world look data with So, think world articulated, real data, to it's probably you options the at next is the the that collecting. been latter

the share a community. of any that NYU shared this the from the independently nephrology in Rockwell, Journal from things is One opportunity as data about this without review has clinics was had that to been we we've journal. It have as very published this appealing by data, particularly with was peer this the welcome input by

I at think say world increasing our each story roxadustat generation it makes me and adoption of we more question? real to of the will continue of think grows, of Triferic more evidence. do the a body the it's you stab the makes to new I evidence want to take advantage take Russell, appealing. and uptake that the powerful But, fair with story and

Russell Ellison

roxa? Do you question repeat the want to about

Brandon Folkes

of generate you being approval running Sure. market drug? this should towards and some maybe think Maybe the that in this should sort drive you FDA? we Or that a a of may on significant just with of the to have data your amounts with roxa of think those drug sort product almost challenges segments segments certain study market the of, a few savings, roxa of beholden able generation do cost to be the to

Russell Ellison

are the should now evaluating, they have Between utilizing evaluating have this are the ESA. and clinics of that where want we to not the whether fine, we're it, advisory scenario an data using adopt Well, get yet or let's committee respect approval. Triferic in they context they its and take and with and to then, the clinics the

that haven't of your roxadustat, We adopting are about question. waiting because clinics hesitation yet if seen this, for part any was

that you're that a I lost roxa, in dialysis, concept think applies. to wait hemoglobin and use the results with they recommend clinics for respect to been to the Triferic whether we And, wouldn't study with to that's still replace reliable running iron maintain iron is using Triferic replace they're it's exactly very or an doing lost that's and in iron much that And to roxadustat, how ESA for respect, getting. you're way the of using rationale that straightforward in haemodialysis. the very

trial. we to keep trial available. the to this that in team the I clinical we'll while such drug roxa study, -- get continuing assuming Meanwhile, protocols his out question. to and answers continue your then on, roxadustat that running we're that ready approved Marc can we're they're So, initiate that working are is a and hope put

Brandon Folkes

Thank It does. helpful. much. you That was very very

Russell Ellison

Brandon. Thanks,

Operator

That session. concludes today's question-and-answer

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

Russell Ellison

afternoon. thank weeks. look We you following forward evening. us Well, with joining of Have days you all for this to great and coming in really the many up a

Operator

Ladies participating. and call. for today's gentlemen, concludes Thank you this conference

disconnect. You may now