RMTI Rockwell Medical

Jason Finkelstein Investor Relations, Argot Partners
Russell Ellison President & Chief Executive Officer
Russell Skibsted Executive Vice President, Chief Financial Officer & Chief Business Officer
Marc Hoffman Chief Medical Officer
Brandon Folkes Cantor Fitzgerald
Call transcript
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Good afternoon ladies and gentlemen, and welcome to the Rockwell Medical Q2 2021 Results Call. At this time all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask the question during the session, you will need to press star then one on your telephone.

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

Jason Finkelstein

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

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

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

Russell Ellison

execute good afternoon joining and Jason by accelerate us. of thank our quarter growth to reputation of strategy foundation you, in for dialysis and the the second combining disease Thank business to with platform development In strength you against and XXXX, our we states. of the our continued solid multiple FPC

business to both concentrates continues to domestically and expectations, our Our perform internationally.

expanding are customers, process with of the exploring We the this our in major business geographically US. in two

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

submission pre-IND infusion of aspects work anemia and working to with patients in refine seek elements meantime, trial. FPC on planned on to received clarification are deficiency the and our written preparatory long-term our study design continue In II logistics a FDA have for to receiving Phase iron with we of home the We response to study therapy. and

that be FDA. discussed medications allows infusions regular of and current healthcare, is regarding based the planned comfort homes. requiring are today are still a treated a on rapidly Home the patients segment own assumptions study the service their being requirements indication with for this potential to growing of therapy infusion trial, which regarding of Our regulatory comments in our model

the the that yet, for left why a not associated is as risk is these has infusion a receive Home to to IV infusion, we therapy home deficiency are patient they or services this can approach for of be There home outpatient with growth are home. process. but a address or poorly are is on has avoid to on a of for to cases, to concerns into extreme rethink bring fueled risk of and, COVID-XX ago, if infusion And And hemodialysis. diseases clarity, failure. expect, rapidly rarely IDA IDA. inconvenient, extremely clinics. regular a is IV the driven home by broken patients for of many heart inexpensive, we basis by regular untreated, about in a and a is Its patient's patient the be carbohydrate iron to into iron treatment For patients when and hospitals visiting are associated is enabled and providers to of it technology infusion clinic fatigue pandemic, growing alternative Oral Traditional compromised has effective caused refer IV iron severe moderate costly of done. patient recently given the and which that iron you IDA, or associated anemia, iron, complexes treatment patients which available number but with option to clinics receiving groups most improved the not able to risk that therapy serious infusions safely rarely for when given health been function home It about infusions. in began might current high hypersensitivity are is decade the with clinic benefit to proven such setting but a trade-offs comorbidity are adequate satisfaction cost a risks, to further in lead products infusions. serious infusion convenient provided the reactions. therapies and to bringing a immune as in Many is to referring due tolerated chronic

exists limitations, transfusion of only of a the often In the in these is an patient. entirely treatment go short, suitable anemia make introducing is in of expense, to for option, the at a of these IDA address well-suited potentially receiving to and blood result We level of a FPC an to need iron the risk progresses characteristics product home home parenteral this IDA believe When remaining that tends for severity, patients patients infusion pervasive new infusion issue the in As it unmet untreated. therapies. for application.

FPC This in failure human energetics resulting trials has believe effect readmissions. the If heart in increasing during hospital perhaps completely also hospitalized patients clinical anemia, reduction help translate of costs in independent shorter of pipeline heart. suffering. people Clinical and the each cardiac home setting. outcomes the already to goal that therapeutic deficiency acute iron iron associated been in outpatient application demonstrated function with of patients heart a More care failure. with additional forms heart X heart United different addition reduce million deliver bioavailable and the to we of stays the risk meaningful so, and than improve the could improving the iron an into symptoms We health in traditional hospitalization. faster, treatment failure, availability FPC; to rapidly and may of IV are in cardiac recover hospitalized In with in iron thereby could have acute infusion, with and these States of by for activities improvement and year XX-day

is this FDA existing a turn with to as of our communicate dialysis development for business, to our the expect revenue the comprised accomplishments they quarter, potential We indication. this both regarding and later to concentrates. I'll pathway business which from Triferic year development within pertain now

expansion, capitated which market a years, as Specifically be during strong is. the and US international the the value we not are our in international markets believe continued of as quarter, revenue source dialysis we will coming

adult footprint. for and expect in chronic undergoing There example, and our traffic patients compliance of The markets our opportunity countries of disease. we a new XX,XXX they patients entered nephrology dialysis, for exclusive AVNU approval for the in to strategy from AVNU and more distribution notice represents to maintain we AVNU treatment in an expanding world. than replacement Triferic Nipro commercialize Canadians a Turkey to first dialysis in marks to Drogsan license rights intravenous this June, key approximately in is annually, further an bring iron the Triferic Health significant an important Medical be Triferic for patients our continue clinics for region. approval hemoglobin the progress solidifying April to the tripe For market with leading to receiving and with with into XX,XXX America the are extended In dialysis option Corporation long-term around Caribbean, our dependent our Rockwell. AVNU to haemodialysis for in concentrates is the agreement June, we regulatory by the presence therapy pharmaceuticals Turkey and agreement approval to Canada marketing of haemodialysis international or kidney Health serve international Triferic a Canada received in space. With in partner numerous Latin company distribute with Turkey. Drogsan pharmaceutical Also established

dialysis Our flat in were net in for first compared the to Triferic sales XXXX. quarter US market the QX, of

to ability US customers number accelerate net other limiting market. were organizations, or of number to as large increased, acquired being continues to clinics discontinue Triferic use the of the well and Triferic that dialysis ownership management had While by to in as ordering clinics due headwinds our due a active dialysis adoption to changes. experience

clinical As competitors clinics into organizations Today, in cost a multiple and heavily the are in dialysis published in reluctant we've have practice offerings a interest is with proceed of scheme. and before, demonstrated number ever slow sold are the different Triferic dialysis capitated evidence A our changes previously Triferic. space been associated competitive bundle and in disclosed, of demonstrating real-world replicated based. than to in Triferic but evidence have savings to genuine absence benefit adopting reimbursement from with occur, more medical

of years from single show We data, dialysis ease with published, hemoglobin takes the continue of something after clinic. Both center adoption recently of time. to One study and a studies the similar facility generate from each utilization which data. that other iron two were collected Two the of an large and academic is independent these covering remarkably clinical stability in trends Triferic. studies is is retrospectively improvement IV real-world

cohort data pilot the have This each the project achieving preliminary trends to We that and XX the meeting. economic perhaps presenting are which data incorporates proposition validates data implementation. as protocol we clinic IV includes midsize dialysis clinical are prospectively critical of There manuscript maintenance from conducted cohort this the we pilot date. reduced emerge potential that a that for a finalizing present, FPC most for utilization. of participated from organization iron year's XX world largest Triferic. also in is these which shown further anticipate important, hemoglobin this and this We At is encouraged ASN in value ease the the new clinics is of several real to important clearly experiences for are and the benefits but of study deliberately at

We for is believe we of that evidence innovative continue a more clear, to are the safe, data our have additional maintenance and Furthermore, therapeutic important committed continuing and real-world operational the to efforts we generate is patients future. growing now in benefit publications on clinical, expect in repeatedly and to be see to To dialysis. efficacious, clinics. validated hemoglobin to financial to body Triferic a of

are from commercialization ahead the seen we I'll commercial stable base a Skibsted company we've facing and of of spending, the the Medical, revenue environment. our brief consider biopharmaceutical Rockwell the I be much I'll call we revenue future opportunities sales Russell steady which the with While to by concentrates us, With for that generating to as present overview. our US, in committed Russell? will products. includes saying of we that, continued the about in very we the large dialysis considering acknowledged a a business, intentional are financial challenges development conclude stage products. turn Triferic

Russell Skibsted

Thanks, Russell.

we operating We with drive high therapeutics quarter, in to disease quarter solid strategy the our initiatives. was generated remain growth mentioned, $XX.X in outside platform accelerate dialysis reputation Russell strong Net the potential growth believe We position financial first ended of FPC quarter. laid our cash As continue for cash, the multiple to to strength by combining quarter, used in we a the of investments and from with we the company's to equivalents out business in the dialysis. foundation, states execute in cash against strategic from million and approximately activities $X.X compared our a second million which $XX first million. of

factors. due of As I our some than our mentioned seasonal was normal timing higher and call, QX on to last use both cash

cash timing use some Our efficiency our discussed as in well expectations, line of and of the that initiatives of we reflecting second the impacts, in with the impact as our both well. quarter was as seasonal

sales million. our quarter were haemodialysis net of second were During million. Net concentrates sales $XX.X approximately $XX.X

sales COVID international on over some especially quarters four the markets. slightly Our our flat roughly of the which the have served in in last prior and effects US, by and the due pronounced customers primarily year, lower dialysis remained than were to population

the for versus his I'll increase Triferic in Russell? versus essentially now We the XX% expect we a of Total were to roughly the to sales of as remarks. back geographic as partners, initiatives begin but first $XXX,XXX, populations in the of improved quarter turn grow call XXXX, flat patient future and closing implementing approximately year. sales both this in our see growth Triferic expansion. product Ellison again with sales of second and the Russell quarter

Russell Ellison

Thanks, Russell.

has the the our expected development expansion clinical as FPC Our global milestones, and platform. development progress company of and well including opportunities commercial Triferic, multiple as near-term for

in to their our and value call important patients I thank every the my working infusion failure. you exciting with new unlock potential and line company. in operator thank are and our for shareholders belief the patients for can efforts our joining program Rockwell with in the I'll hospitalized IDA like I for for dialysis want of your turn sincerely to to continued fortitude. We heart proprietary I to our today FPC business and Medical. before yield in the acute long. hard FPC to would to our work advance conviction innovations for questions. team home develop Thank our interest alongside their now opportunity that have over platform patience for the


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

open. is line Your

Brandon Folkes

for thanks Hi, my questions. taking

yet? on the we the an should about terms the trial, a in agreement Thank then you should of elaborate clarifications lot of trial line, this of on so as think secondly, believe base going is G&A you. can on the Any infusion just home forward? there discipline And you if the and do extent how just date? start And something we think to close you're of color

Russell Ellison

even actually trial seek number Brandon, first take your year. we We all These be And this face can these you and discussions should issues email we days, where don't to Hi, chance really with letters you initiate of done I'll pending get anticipate question. voice FDA, and still to by there's questions a the able and have to documents ask really clarity. a where it's to real a voice to time. want face these dialogue or

from questions like the we So, this. to and do have unfortunately, there. and And to the get it we ask take it intend answers

can you far Brandon? As questions, other your just as that? repeat

Russell Skibsted

new the be expenses and not company, I not expenses, expenses think and It's whether doing R&D order in other to think are quarter, we both where regarding deliveries, he mute. to business opportunities trucks dialysis the third-party respect the the efficiencies, programs, in whole expenditures returning hopefully focusing forward. at all early second that say going probably necessary progress on are to we're show value I've I things showed a and but in there, like, to of said so, what terms should we're we of this entire the about say, luckily our I at making think, grow within doing of be are that we're great and supplying. freight deliver this analysis contract in in in should maybe on providing I that functions country not our being that the before, currently in terms being G&A we're business tell opportunities, also to guidance with to manufacturing went spend. that talking the than or of guidance customers Brandon, some the supplying terms out going we're after And be whether chain sure the to to the - business, able portion with large but to but giving able progress the able reduction looking some we're a optimistic too throughout the great But we're both achieve going about that just primarily of question, at but of looking we're we're make what we the like on terms it looking as going also the simple though, date. the of that was we're be at actually booking giving to empty or very that going a that's we will concentrate operating dialysis the and chain It's normal really really, to supply through in not that with that really, time that that literally respect we're things, we're to making and to business. not supply

there's think for it's But bit we give color much opportunity initiatives of So to premature a there. a little just on yet. me those lot

answers hopefully So, question. that your


Thank you.

comes next Selvaraju from Wainwright. Ram HC line the question of with Our

is line Your open.

Unidentified Participant

[ph] Magnus good I taking a Thanks This questions. have Ram. afternoon. Hi, few. for is our for

think in saw performing of include the outcomes. prevalence of FPC patients, of COVID-XX II and And the to analysis study it the COVID-XX are do this kind high a excluding trial, recent considering was you you with post-hoc around which centering that if there's group? patients? of year, in Phase Firstly, you some the do and decide poor associated value patients with possibility published We hospitalized COVID-XX anemia showed

Russell Ellison

to want reply? you do Marc,

Marc Hoffman

that. take a I'll Sure, stab at

considered on it that was plan. material of we've so have We of built the So, honest trial a impact be question. factored into part understand and our we've recruitment it, we that COVID-XX. with discussions, will thank heard the as is not impact infusion healthcare less for actually the the previous actually plan. you, benefit clinical To yet And contacts, you've development you the home of from into that

as patients, to as with As far on number in have so I issued analysis COVID-XX. seek past co-factor, of something product the a that's year, in post-hoc think The not been advice of XX of a clinical as COVID-XX there has further any know yet subgroup trials I not the I FDA the on. of use regard COVID impact we in. guidance kind been that also that's factored both will our said, over and

Unidentified Participant

very That's able useful for thanks. of going any reveal educational Okay, patients who be to may And for trial, to this are you are us. be this on then, trial? developing FPC materials details you

Russell Ellison

yet. of Not part itself. protocol the They'll be a

Unidentified Participant

outside, I see then, And completely of being seen may in of being we've just this reports caution left the if to issue or dialysis people's home of not in of light delivered kind Do trial kind in, couple your this an into as and Okay. due of more is squeeze kind instead - COVID-XX. of abundance of homes, supplies a you

Russell Ellison

the will for trial, with health been participating people to in now, issue point. talked yet, I and that not that them and care is the this so we've to has will that, now. least not That's not good say at pharmacies talked an What up be home a that about the that on we've

Unidentified Participant

ex-US Triferic to in additional you And that. the potential update any commercialization glad partnerships new territories? of hear able are on just then finally, Okay. We're us to for

Russell Ellison

discussions ongoing. what we've but now. that's those in interested to other countries nope talking already, Obviously, discussed what right parties we we're still are Beyond have

Unidentified Participant

congrats questions quarter. our Okay. Thanks taking for on and the

Russell Ellison

you. Thank


session. concludes to now Thank back call closing I for you. to would Dr. the Ellison Q&A the like That remarks. turn

Russell Ellison

you a thank for have us and all good evening. Alright. joining Well,


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

may disconnect. You now