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RMTI Rockwell Medical

Participants
Claudia Styslinger Assistant Vice President at Argot Partners, LLC
Russell Ellison President and Chief Executive Officer
Marc Hoffman Chief Medical Officer
Tim Chole Vice President of Marketing
Angus Smith Chief Financial Officer
Brandon Folkes Cantor Fitzgerald L.P.
Blair Cohen HC Wainwright
Call transcript
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Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. And welcome to the Rockwell Medical 2020 First Quarter Results Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

today’s being that advised be conference recorded. is Please like the Ms. conference Instructions] I to hand now would today, [Operator over to your speaker Claudia Styslinger, Investor Relations. ma’am. ahead, go Please

Claudia Styslinger

Welcome representative for call. Medical. earnings of to quarter Rockwell Partners, is Argot Relations Claudia Styslinger Rockwell results Investor the first Medical’s This XXXX

President Financial and from me Officer; of Hoffman, Medical Officer; Ellison, Dr. Chole, on Executive Vice Officer; Marketing. are Dr. today’s Marc Joining Chief call Angus Tim President Medical Russell Rockwell and Smith, Chief Chief

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

estimates reasonable, these this to information should such These beyond statements assumptions, subject change. upon which are Rockwell’s While current different. set Actual filings, could are in on forward-looking various inherent on which Rockwell date be without statements us any limitation on undue are believes statements subject placed and and to which the uncertainties, forward-looking and based reliance and based those forth to uncertainty. forward-looking are not release SEC of be materially many risks our are control and are subject including results available to of

except Relations as forward-looking for result be as recorded reliance is on otherwise and can also audio on same be these alter This undue Investor May conference not statements. by accessed expressly call future on whether you XXXX Accordingly, call being update place webpage. Rockwell information, events the of can obligation accessed rebroadcast a on or XX, This law. disclaims Rockwell page. should Medical’s any required statements new or any to

to Dr. would Ellison. I time, like Executive Officer, call turn Russell Rockwell’s Russell? to conference Chief this the At over

Russell Ellison

thank and as Board Medical, and addition is be or Directors. today. Good you role It for to your afternoon, the you an to role Thank President everyone, Rockwell honor CEO on of new you, Claudia. with my continuing time my in in

CEO and products and for which shareholders our as and more Medical company, AVNU to products into potential of patients FDA Dialysate other by diseases. identification pursuit Triferic and new charge is medically- on Triferic maximize and approved dialysis Triferic developing X adoption indications and our will My Rockwell the for in the strategic a of drive scientifically-driven

business our look will providing light up analysis; on on I open the and the to forward Q&A. an from data findings our we the of then, community, hemodialysis call. approved address COVID-XX our progress Today, review you commitment of on our to in update with we’ll our pandemic; the other pertinent Triferic X corporate and real-world retrospective FDA financials; updates commercialization of and a products; to particularly

in, and am I knowledge I’ve the FPC or dive want pyrophosphate and in Member, we knowledge to biotech, platform. my about and decades pharma and Consultant Rockwell of some Through and give to future. you as my as I Board in-depth vision for joined a gained Before role Rockwell my particularly perspective technology this executive and on I ferric citrate of transformational its potentially product. Based our of the medical attributes excited experience why

market immediately XXX% any platform. in first I the And today. As FPC delivers It bioavailable other you iron patients, for by inflammation. product our product the Triferic know, Triferic iron is from unlike believe unimpeded commercial is

in iron potential platform the and meaningful action, across to holds By deficiency transforming I indications. believe globe clinical patients and deliver the managed providers, virtue pharmacoeconomic this thereby FPC to of therapeutic way our benefits mechanism healthcare of multiple is the

see opportunity of and for is shareholders. potential for technology, X FPC this charge I our My to And patients areas. actualize in

the opportunity. transform for anemia with to have unique is hemodialysis way patients us with X hemodialysis formulations managed first Triferic provide We the for FDA that is ability now approved patients. The

Rockwell future, time I’ve is care to because dialysis believe the of hemodialysis as goal the Triferic medical has capabilities to the pharmacoeconomic the industry scientific, Triferic and spent leverage over and is the based my a build my our of on data. become lot making accelerate and of in dialysis medical, establishing, portfolio time. standard look career in potential in the in by the to And help I underpinned experience, that to setting, is adoption I my decision

be in and plan. basis Generating pharmacoeconomic number part the collecting a the data we additional from clinical on including of data, will data ongoing increasing are of data fact And critical program real-world clinics. our from an

which give we this I’m position to from the the today. in next anemia program that Further, is first with believe year HIF-PHIs, of of to real-world investors XX months, management that XX are on the are agents. stimulating to in alternative the over readout change, a next an hemodialysis I the the course erythropoietin of going anticipated call data pleased introduction to starting

products Triferic During various to based the well development patients. including is my therapeutic been in on positioned And anemia of in hemodialysis participation HIF-PHIs and alongside my treatment more career, provide involved experience, HIF-PHI. a physiologic of to I’ve reliable I believe

states. I in medical citrate the value iron the is clinical or deficiency conditions attractive of disease to treat through setting, enable where for molecule unmet a that molecule it make same see development the The transform other secondary variety I hemodialysis to ferric pyrophosphate way in creation attributes should the believe managed that needs. with the exciting is potential of FPC

To look commercializing experience into believe extremely new prove outside I of indications future have we setting. will and development. we from end, areas to the initiatives prioritize which developing of other for the that therapeutic as launched and dialysis valuable We to move wealth hemodialysis, gained therapeutic identify Triferic have in a strategic

exciting us. a is very This project for

critical to out address other technology build plays where disease role. look we iron As the and platform states a

the will you the of intend creation. and the be potential, our we projected And this states on focused to on will be today value year, hemodialysis. to promise time in to on explore business call and commercial the concept proof cost presenting of clinical clinical and disease with information Our we feasibility later

joined November traditional our company capabilities; Marc in call Chief the Chole, Tim Vice by as President Officer, experience XX efforts the Dr. Medical our by XXXX, life-science December medical in products. IV Smith, than Financial who Officer; joined our in Hoffman, I’m part and on Angus products, today enhance us Chief of iron to Tim of XXXX has years’ joined more and marketing including Marketing. our

hemodialysis dialysis our the is to business. commitment our concentrates community Underlying

which X million in $XX the revenue. more from the We than are number we in generate supplier these of annual products U.S.,

with customers is growth While paving the in on Triferic. is allows for driver with industry way and forward, Triferic and discussions and the key concentrates customers clearly business develop the for we having profit going our to the harvest relationships are us business

helped the COVID-XX pandemic has these our of Our face with response the customers. in strengthen relationships

last I commitment to discuss. our incredibly on of And to the customers, way our over which am X proud rallied I’ll months our has deliver the organization

potential differentiated hemodialysis approved The patients other indicated Triferic, and mechanism benefit iron our replace is treatment. the It the unique which innovative and healthcare in hemoglobin FDA part has maintain dialysis of and to system. commitment during to of action, therapy each has patients in dialysis the U.S. the to only

overload iron ferritin and placebo, increasing profile toxicity. iron safety delivers levels comparable is with hemodialysis to associated a and Triferic immediately without with maintains not in and patients hemoglobin

Formulation X Triferic with access and a Triferic that launched Triferic enhances later therapeutics for formulations few We AVNU just for to AVNU patients approval FDA-approved. of XXXX announce that our IV to in expanding United Triferic now by have is we unique innovative year. greater Dialysate, were excited or in indications. development We new and excellent formulation of the of to it Triferic introduce which ago. provides May AVNU clinicians, FDA administrative weeks Triferic and our options plan States we their this platform, an the the

earlier, of As COVID-XX the the the of industry way few company proud business. word our virus to has on pandemic. about want and say impact responded the I’m I I a our to And mentioned

dialysis patients comorbidities, managing patient are world treatment times some receive per has the of on already X the week. the crisis. because multiple knows, The quite are in everyone unprecedented an and the challenges challenge face is lives pandemic, they the faced dependent facing literally many and carrying industry As unique

the put further downstream has COVID-XX and can on this, acute one our stress healthcare is impacts of critical. of multiple Furthermore, be outpatient this absolutely failure, kidney dialysis organ supporting role and providers including times patients both like failure, and in At clinics.

business. in still a world me middle crisis, impact new to it’s us to few are the and to While when the the timing hard offer the normal, let our of a the predict of on returns thoughts we for

supply we’ve no for our to First, or chain concentrates seen either Triferic. disruption

the where to build of our able demand small of higher seeking clinics certain been shortages to or certain products are work our for we’ve In fact, crisis stock from suppliers. fulfill the face to concentrates, other customers in on pockets with facing safety

paused of to sales the because nurse our clinics representatives, vendors and of and to closed patients, the change crisis. nature Second, significant more or protocols non-essential including managing have dialysis in any fragile the doors educators, focus less have on

efforts promotion for the where medical been possible. efforts the our we our working to education to continue has ability This Triferic, and of though, impacted continue virtually have

and clinical We in in the our development the globe COVID-XX regulatory closely of also evaluating across particularly the impact outbreak potential are on India. China timeline,

that industry essential all following and And through standing in who our I come extraordinary with like crisis. sure life those commitments therapies. I’d workers. and Finally, distribution of the particular, to of efforts In and face in on dialysis employees work manufacturing proud dialysis efforts are the saving the every to the on we the patients patients clinics working applaud to ensure of day make our receive the to industry their to frontlines of the am

million, highlights quarter, $XX.X to our were the some the highest turning since net XXXX. Now representing QX of of sales first sales

nearly Dialysate, Triferic patients representing on the annualized XXX,XXX X,XXX with quarter treatments. nearly therapy, ended we For

programs increase the later evaluation independent committed in and small will now and from XXX% Dialysate a additional XXXX, on launch clinics, and for Tim organization active XX, the call. Our December represent dialysis details provide Triferic XX metrics

to quarter events will be also Board for our as business saw also thrilled Triferic Medical, Radie plan. add The in were AVNU, to great business Bob of executive, We to as a and execute asset India development first mentioned, Rockwell of FDA Rockwell commercial, I’ve significant clinical on experience Pharma. we Directors, Sun Medical. development to licensing X Triferic and The Bob’s our our significant rights of approval

of highlight that Triferic. become from on our additional benefits out board, data my commercial tools to Through joined company building the demonstrate want progress work in the Triferic. as to I CEO, data it’s we’ve and to program benefit clinical trial Finally, clear supplement can the for made the our I’ve team since real-world our potential

tools these is of prospective to real-world customers, particularly pharmacoeconomic of measures. experience is requested by it One the other and that as frequently relates customers clinical

which have program add excited continued data first hope to I And to and this from of data, say we increase the We’ve XX% to XX now readout we mind, from the present on from updates to will December real-world ready front. this a collecting XX, our be are XXXX. clinics first in call. program, are many on am the With we this this I clinics

With that, Dr. turn the review our Officer, over let to Chief Hoffman Marc? to Marc me the Medical data. call

Marc Hoffman

the today. Russell. to presenting real-world you, readout Thank data initial program excited our from be I’m

context and of As program. let is data for Russell analysis first, mentioned, Rockwell. of me the But the incredibly real-world important this put the overall presentation in collection

the are in Triferic these medical top priorities commercial, that collect we plan potential the come. and We to the are discussions enhance XX analyze collecting of to has development to across mentioned, data. program the in that company and my the one years Russell output been to adoption for joining critical and globe data has As from a believe driving U.S. business since clinics now to this dialysis the develop from

adopted us Today’s this provided an for readouts presentation be has their clinic of clinic first is early presenting at meaningful from the we independent just that and point in Triferic drug life program. Triferic. and metrics after patients given patients any be several hope dialysis data will lab, XXXX. Today, The various from of in what will utilization clinical, with before and they quality adopted XX approximately time I

are well-controlled which switch period are criteria, data the months a selected from those like to Triferic. their presenting of are specific generate practice. X XX randomized registration Triferic months In following unfiltered. used highly real-world not to patients We baseline prior to contrast, reflective data uncontrolled trials adoption to clinical using is real-world of fully data, and In of eligibility

any This site. clinics all-comer schedules, have did criteria, not practices. nor trial immune is representing into management is at protocols the experience or here and real-world patient presented data Rockwell The the data constrained this any input by or selection clinical

included or patients in [ph] In outliers are active who fact, analysis; an patients considered be patients example, with who [party] would it data for traditionally hospitalization. infection, bleed

data objectivity were and to important assure our represented representative results is are clinic patients developed single It be used. graphs that the To in by XX results of statistician. different and and here were observations, observed all note independent an not approximately practices a of may were that procedures independent

of At a of through missed months, XX in quality ESA we’ve substantial we XX% indicators. and observed level, reduction in observed utilization. reduction levels, and a the traditional life Triferic, iron these that more stable in saw in reductions, following IV than high improvements utilization also increase adoption the is what clinic the hemoglobin to analysis at key in the XX decrease background to the treatments of Against

specifics average reduction we long-acting of XX.X% week, we change XX% dose which in for following at looked the the transition. the patient. sixth contribute in fifth per in a and average where average the to infrequent, per transition in weekly following during quarter and ESA, increasing ESA to in patient, the may changes This utilization. in those the ESA reduction the that elapsed quarter clinic to dose alpha ESA patient per saw are to the [ph] a Triferic time Of dose anemia, [low utilization, per change to Turning erythropoietin] the note, weekly uses

traditional in iron dosing, patient, a particular IV This clinic change week per utilizes total the as iron traditional gluconate product. What sodium both at basis. looked ferric on IV decline also and We traditional per their first we utilization in was week. iron dose Triferic. following the reduction XX% per patient, observed observed adoption average the fairly in the per the and sustained in large We rapid, IV of quarter

at by this the XX% compared of than levels period, observation period. ferritin to in the first the serum Furthermore, during XX% baseline decreased greater and over year, end

and of within grams the observation as iron deciliter period. concurrently grams to noteworthy XX grams the to XX.X terms changes X continued of range had hemoglobin to to per reductions per both occur per Triferic during hemoglobin, and IV throughout hemoglobin These levels with rise of In XX.X they utilization. in deciliter, period, adoption, increased baseline every patients observed are ESA target the deciliter within months XX

levels in have quality shown studies importantly, And hemoglobin patients life. hemodialysis are that improvement associated improvements with of in for

at also by trend missed We looked in the treatments dialysis patient.

clinic can but from clinics treatments on revenue missed as Importantly, profitability, that have absorb. a significant and impact patient visit, to are forced have labor on lose costs they a the fixed out facility

quarter in During of following baseline there observed missed sixth clinic total in patient the percentage X.X quarter potential is X.X XX% switch per missed A the following reduction X,XXX sixth observation of of the total quarter that in treatments treatments by the was following reduction the during the from number period we to switch. a switch. visits Triferic, average the to per visits quarter. was What the period, the

this were clinic adopted life we to us able to to with measures CMS. all of provide able provide Not us. data that that Finally, fortunate to KDQOL-XX or these are was the by clinics very was pursuant willing tool quality

presented Triferic. quality life to following look unique this the and of measures opportunity of us So at with the adoption trends

physical their and mental patient’s closely shown outcomes. of studies tied perception a Importantly, have is to patient that function

of X of activities. ability how a measures detail life with measured Physical out and to The of life. different assesses disease skin, health kidney activity dry interferes of burden social associated disease as kidney disease muscles, depression little anxiety, level Problems as assesses and symptoms or more mental of patient’s instrument KDQOL-XX. This summaries, To of is tests, which provide quality such feeling washed the and sore kidney appetite disease, much or general you limits, desired energy lack with part accomplish perceptions daily axis. underlying measures itchier and their with drained. which what is validated on across

on the travel. scales the on the or life, house life, scale, are each of kidney score a year-over-year. higher disease disease such life. We to around of of effects the indicating point the scores Each their quality ability better their component work composite of XXX on measures Finally, improvements targeted scores, on as and with kidney KDQOL-XX impact day-to-day of scored on observed daily

The dialysis DOPPS, patterns on looks who outcomes and practice are dialysis world. study, around at the patients

their do how While dialysis. this quality of well data is strong highly a subjective, and people how DOPPS feel they correlation on between life found

So ESA today, from strengths in study implementation extraction maintained from data single by management by This is are limited we data iron The anemia use medical unbiased demonstrates the at of hemoglobin, and observational their IV uncontrolled allowing months iron presented XX and the of traditional in examination IV concentration after clinic than the each The to Triferic independent Dialysate dialysis hemoglobin record, protocol. the study its more XX of setting. observational used study XX%. longitudinal to nature. prior the treatment, into reduced as introduction following the that of electronic this a clinic Triferic

ESA the reduction use is to an collecting from clinic further The patient there other results for greater analyzing cannot data. well controlled interestingly, patient PRIME. XX% this in database real-world mix, and time, a clinical clinics with observations trends our of by and are to strengthen but a Triferic, dialysis number data to consistent committed settings outcomes, different CRUISE trials improvements generalized increasing decreased the be in for Additionally, over of presented than treatments. with are in as as and Rockwell

plan. launch Tim? I’ll metrics hand Triferic to to Tim over call the Chole that, AVNU With and commercial discuss

Tim Chole

and at in joined for more serving that’s experience as iron years Watson spent treat I’m where December I’ve Marc. XX patients. pharmaceutical some iron product portfolio of head Ferrlecit, Tim traditional device Thanks, than the IV industry, used marketing the President to Chole, in a we company including the XXXX. and dialysis launched pharmaceuticals, at medical I Marketing IV Rockwell. anemia Vice

So Dialysate first with details Triferic that I’ll the some metrics introduction, dive for of our of the quarter. into

pandemic had to were U.S. contracted dialysis in As treatments. Dialysate. to contract MDO signed in approximately nearly contracts Triferic emergence patients of X,XXX annualized are the COVID-XX of particularly March the the X XXXX, new we The contracts, XX, we conversion clinics therapy In with our new quarter, by March. representing the on from impacted adopt XXX,XXX

staff With X in and held adoption for mid-March that on on trained our for the patients training clinics in customer, we and the that on their clinics, off were in another pandemic. the the MDO in face Triferic due And protocols dialysis queue COVID training as so had protect could to able administration the of for all approved had to administration focus we to clinics X converting, that complete they crisis. March not

small or clinics chains active evaluation XX, committed dialysis dialysis and with increase represent and Our X,XXX more clinics independent That’s a patients. XXXX. now than programs XXX% December XX from

very we’re largely is during committed the quarter. who first clinics. to And multiple clinics strong the program to programs pleased in So progress the own attributable of these number of customers the with we’re making increase with performance prospective the the

Dialysate period. clinics Evaluation the quarters active for now to since product month programs X been Triferic launch, and full have allow for X sample

by our XX% today that the to with is from rate product, commercial clear gained evaluation to Our majority conversion Triferic programs stay clinics with significant the evidenced tend you’ve a observation as contracts. of experience on

throughout to commercial company, with to our including challenges our virtually tools presented force companies we with to has field communicate equipped customers. COVID-XX our continue have while And

and COVID-XX our communications our we to resolve adoption for reopen of U.S. of our states reacceleration the growth begins pandemic with as evaluation continued programs, Triferic between to the So a business. expect in maintain and customers, to see efforts substantial

of Triferic Next, I’ll or Triferic. Formulation turn to IV AVNU

maintain mentioned patients hemodialysis-dependent March. replace in the FDA-approved As earlier, to the we with approval in AVNU of With chronic Russell indicated thrilled as announce this FDA products hemoglobin Triferic Triferic adult to iron approval Dialysate were disease. Triferic AVNU and joins kidney only

clinicians. to to the delivery innovative more administration hemodialysis greater administration Triferic allows being Triferic for the using to access intravenous bicarbonate. hemodialysis where dialysis expanding providing the our therapeutic regardless with adult clinic The administer AVNU and by of by is And is centers of patients dry platform patients therapy is patients, designed for thus in options bicarbonate used. to Triferic mode appropriate enhances cases

past, In launch. dry prospective to terms AVNU, customers technology. who bicarbonate our to unable this Triferic been customers the already due increase of interest plan have are of use includes adopt to impending their awareness to to expressed in reaching the have for but the we launch of it Currently, Triferic beginning out outreach in

that for those with dialysis to We’re adding have the Triferic existing for Dialysate organizations also we established Triferic to starting AVNU with to engage agreements. set contracts stage

systems and this So we the integrated clinics same availability are dry utilize launch will who Triferic. preparing of that products access that bicarbon their signal year. educational can to course, to marketing programs commercial later have of time, At we communications

inventory in potential during we to are Once have the in the Dialysate manufacturing several initiate and we the thousand we programs evaluation quarter. manufacturer for And both risk. from these us will We waited this parallel, for and product Triferic In end, position the label the sample name. than of product and a final manufacturing dollars initiate hundred our programs saved at expect apply prospective to launch be third with customers product available, in commercial decision rather the write-offs. approval brand learnings FDA-approved to

Evaluation for free months. Clinics programs out we’ve will for Dialysate. nearly identical what Triferic samples to to X access rolled be have will

that reviews we while schedule to the parallel, at lab clinic them and impact we’ll and is onboard staff. also their to we’ll customers to In the months, training evaluate with are assuring with month complete. as paying negotiate X proper of once the XX begin commercial XX ready the X clinics the clinics XX, Triferic, days education contracts During evaluation so of

first we X-month valuation in targeted evaluation the launch the reached their for Triferic in commence AVNU adoption the as of the sales to commercial of early programs program. Accordingly, completion clinics plan that QX, in fourth quarter point following XXXX, of

AVNU reimbursed by the anticipate within continue established has In be been terms It prevalent patients. Triferic is to ESRD Medicaid patients. that we CMS Medicare bundle for increasingly the also reimbursement, will for of

structure importantly, detail to who patients But on we believe it our forward Triferic need plans and We the us to broadly transformational this that months. accessible therapy for ensuring the the progress enables an margin, look gross most. commercial attractive more is in make AVNU to coming while providing cost

And that, Angus? our a turn Angus will CFO with I for of review to first financials. it over our quarter Smith,

Angus Smith

Thank you, Tim.

Turning our results The first more for to fulsome the would of now detailed has read end to it highlighting afternoon, accessed of quarter more description I quarter. our start this be issued been our in years. encourage both the in disclosures our filing as of can as results. our the press XX-Q we I’d complete release as for investors And to results. as financial as is a first which quarter, like of strong several liquidity understanding position by our the well

execute provide improve to During company business sheet our capital with value. the plan, we we to achieve shareholder milestones the our need last plan and the to fourth embarked believe that will create balance on quarter a year, position us on we of and

during approximately we $XX in $XX.X was to first end, the $XX quarter to compared quarter, the cash, used $X.X Cash investments over XXXX. million of of in on attracting XXXX. successful We ended available December of sale during XX, quarter for which first cash non-dilutive. that most Rockwell million million, equivalents and were capital the of activities To was operating with million

announced a March agreement sheet offering discounts. gross XXXX, Partners stock as balance well Capital approximately underwritten deducting XXXX public financing $X.X of in as was the with before Innovatus by proceeds million of The for underwriting debt company’s February common the in strengthened

million, and drew access at the of We facility and have milestones to the million another certain $XX.X loan on satisfaction closing $XX.X to conditions. subject

Additionally, we at-the-market deem amounts facility, business our restrictions plan, approximately stock we that pursuant we shares at on of our such to and appropriate, common million may times remaining to support sell, to $XX under certain which use. have subject equity offering

million, XXXX increase sales an of of for of due was were XXXX. in Turning a the product May of compared X%, to quarter increase statement, of first income U.S. as increase an sales the to launch Dialysate primarily the $XX.X XXXX. result of sales quarter for The first Triferic in to $XX.X commercial the net net million

in $X of first a was $XX.X million million Cost of in increased the Gross compared of sales quarter first Triferic of XXXX. Dialysate to an during compared XXXX. the sales in in primarily result the a cost to $XX.X of of increase U.S. of resulting gross of quarter launch a first XXXX, the product XXXX quarter million, of profit profit and million, sales gross due first XXXX of the commercial quarter $X.X in profit May as at to

and a reduction operating Operating marketing $X.X a offset expenses, reduction loss million by of first in was in $X.X $XXX,XXX R&D The million expenses. to included expenses, of XXXX. loss $X.X the first partially million for from in driven selling by a quarter in XXXX which improvement the $X in improved million in quarter primarily G&A reduction a expenses, operating increase

Dialysate, made Triferic. launch support The result the quarter continuing our of and to XXXX by offset decline sales in expenses of investments a are year-over-year for largely our in infrastructure Triferic were marketing sales of partially our during and we marketing the the investments first upfront and

By in reduction decrease settled G&A driven way, been The the cost was in costs. primarily with earlier the enhance this we R&D increase call. presented including platform, and we expenses that in that our on expenses now consulting to and our stock-based support to reflects matters the generate are a and have making lower and FPC platform by the data Triferic legal compensation various associated data medical litigation investments

XXXX the is going forward $X per basic for is and international to activities or business loss net loss per Triferic. diluted An million share. first area XXXX of in or $X.XX to diluted $X.XX first development quarter share, million a company and $X.X Net and of that basic was additional for the quarter our compared important of our

to shareholders. significant for company opportunity we the A create we increase access objective is an And in see to markets. do to international as to value this, our Triferic

some Triferic, has of real-world Importantly, business we some are which that us call potential that development discussions today, are for of on believe globe. the we the the help to accelerate generating data around was the earlier presented having we

first with we Pharma agreements the the is Sun for and license a During in attractive India. exclusive market entered potentially patients. over with hemodialysis rights India supply quarter, for commercialize into Triferic XXX,XXX Triferic to

regulatory we a to Sun As India study. not may determine a will to may clinical step, meet expect which a in require or Pharma regulators with next pathway approval,

outbreak China, expected We postponed it support quarter. the a to second COVID-XX been Triferic partner, for trial filing a meeting initiate April, has for we in to In this our approval. the are and with occur to working diligently initially during will regulatory Biopharmaceutical but occur during Wanbang hopefully

this of Access that with to in at continued the world. later to year, hemodialysis in expect initiated the will largest the China. We pending has over a making China, years COVID-XX rapid this increase it resolution recent outbreak in rate patients in market single in be study China XXX,XXX the hemodialysis

effective range remain about the the participate sales. low- in the an China of excited with commercial to in if meaningfully is We Triferic approved product potential to royalty Triferic in opportunity mid-XX% we for and expect

AVNU is new facilitated We’re Triferic in in also on the which drug the for approval by cusp Canada, the recent of U.S. of filing Triferic submission our AVNU

towards these we to are a America, partner in Triferic progressing on Peru awaiting In In the markets, and distributor. distribution Dialysate of launch Dialysate sold the for transfer approval there. in a Triferic both received regulatory our Chile decision commercial we price South with of Triferic

that prospective be We potential some and discussions as for health-economic such Europe Triferic are in Japan. that mentioned, observed geographies, on and I to discussions was we as benefits of expect with and licensing call Triferic. with presented leverage this And other partners may to highlight the pharmacoeconomic data real-world also continuing

both back studies the accordingly, Triferic turn and are I’ll will markets believe facilitate for Russell. we are of diligence to these already markets some discussions inherently the approval, having to We regulatory we require are that call complex of Russell? clinical the due in and partnered. where now more

Russell Ellison

to open Thank line questions. you, now the Angus. I’ll up

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

is line open. Your

Brandon Folkes

during Hi. taking progress congratulations the the quarter. questions my Thanks for on and

both are paradigm, into fitting treatment from strategy? launched? see Firstly, you Triferic they where can the about change talk Any prior Dialysate you with IV the Triferic once

And these clinics operations product? we the converting you. just then, be for the whole patients? would over? their once period trial think conversion your certain about revenue it are secondly, be should with Or clinics to Thank Would how

Russell Ellison

catch and your I second second of Yeah, Tim that, one take will part take lot. the question. thanks first your will But sorry, your first your after one, quite could you repeat Marc a – if question. perhaps didn’t then,

Tim Chole

take Great. Tim. This Yes, question. I’m to happy the is

use estimate for solid So, is question. bicarbonate per XX% technology. believe number for significant. IV clinics XX or is AVNU bicarb to market, current we the And About systems, is U.S. that treatments that about which as year. We shifts hemodialysis solid Triferic opportunity machines the million of utilizes Triferic thank increasing that you

are we where really that that’s for treated AVNU there. patients focusing And will Triferic be promotion of for

to don’t be all get current using anticipate those Triferic and IV liquid formulation. And Dialysate. formulation with customers in powder they that this packet. happy Our customers quite they’re convenience are interested we with from bicarbonate And with the the our mixing

So markets this X look incremental really, Triferic as these target for we opportunity AVNU. and separate at

Russell Ellison

sorry that. of question? what I’m was second the about And your part

Brandon Folkes

programs you sort So be evaluation decide or basis, this operating to with on forward have to they where that cross patient-by-patient of standard implemented are post a Triferic? clinics go the would the Triferic to procedure shifting

Russell Ellison

multiple shifting the in this. It’s going – I’ll to with iron to exceptions, them. on take managements have have same for difficult of Actually, ergonomically clinic. they’re rare

not of the like the do to patient do reason that unless to by idea consistent Program there for use to a clinic given it; they specific for and that created the patients is having across clinic So hence, medical idea Triferic. protocols Evaluation hence be all of a

have somewhat so focused protocols COVID patients delayed their they’re those by preventing and because epidemic, their staff in and infection it’s been that around on the protocols And the that.

Brandon Folkes

Great, very thank you much.

Russell Ellison

Okay.

Operator

And you. Wainwright. HC next comes Thank from Ram our Selvaraju with question

is line Your open.

Blair Cohen

Hi, Cohen is Blair for on Ram. this

been me, and Just providers? AVNU one thus for far like the what is Triferic for among dialysis physicians receptivity

Russell Ellison

Tim?

Tim Chole

Yeah, sure. Thanks for that question.

I customer as customers are really the this mentioned, many create a to from amongst haven’t So just able base. The solid beginning AVNU. but use product. that unique bicarbonate interest we strong to been bring and because of pharmacokinetic in can coming benefits its it profile, exclusively is we technology Triferic. expressed product, that interest have utilize interest customers the And Triferic FDA The approval following of our awareness have in have

Triferic again, soon be So a now using the that And with that to do have start interested for we it. we’ll pipeline start programs, as are we of AVNU reason. evaluation as customers able

programs. been good. receptivity has generate efforts for awareness in our about So to And and customers to preparation again, just and we’re starting the the approval, talking evaluation expand

Blair Cohen

Thanks, Perfect. guys.

Operator

the showing like Ellison to I’d no remarks. to Dr. closing back call I’m turn questions. And for further you. Thank

Russell Ellison

everybody, for to want It’s And privilege to Angus update Yes, a colleagues, our I participation, participating. Tim look thanks, attention. great you. Marc, quarterly our thank next a and day I my to for you on and and time Have And opportunity safe. the and to thank you. you And company. your forward present stay for to update their been

Operator

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

have great a now may You Everyone, day. disconnect.