afternoon for and Good Thank our you you, thank joining call. everyone Ilanit.
was quarter for second initial The pivotal we I'll for Triferic. updates our share efforts our made significant portfolio. Today, advancing Dialysate around as Rockwell headway Triferic commercialization
formulation Triferic in from released NDA and CMS progress studies Our announcements. including for recent of IV two outside in States, data just United the the markets China
to we innovative know, of continue powder Triferic build XX, as for filing for unique initial and recently an NDA its may a ampoule have a our the both to packet version formulation, and date with see in dialysate launched you and We just therapeutic of hemodialysis PDUFA the efforts to therapeutic recently for awareness are was accepted submitted FDA comes the IV which that May which March liquid in to an XXXX. And Triferic as platform attributes. formulations patients about treatment we're multiple excited we of
events. a anemia patients higher who XXX,XXX traditional treatments these are extremely and during stimulating over and which IV patients than the have world today both costly including in more and And associated important for receive current hemodialysis treatment, treatment people for issue million is receive the the Maintaining each roughly protocols, iron lose agents, because United been hemoglobin and States. adverse ESAs, healthy are with is XX% chronic address There condition. iron iron X to in IV these levels ferritin erythropoietin levels traditional
iron without maintenance actually the with delivers develops risks and the – other ferritin hemoglobin levels and the Triferic, that hand, need associated that other therapeutics. on the without hemodialysis increasing patients
and iron Triferic and replace FDA first directly only physiologic hemoglobin iron transferrin. therapy approved to indicated and of natural the action mimics mechanism As completely to levels, and donates homeostasis iron its maintain
And this patients way managed we the all population. appropriate shift for haemodialysis is has to the believe that in anemia substantially Triferic is that and potential
the U.S. expectation as be penetrate the by estimates to time market market is care. of over of Our of Triferic million peak suggest our able that $XXX we this establishing a opportunity a alone. will standard in And portion substantial
starting backdrop, this during several milestones Dialysate of launch significant against with we Triferic. So quarter, achieved the the second
During the a handful first sales consistent of with not our Triferic commercial our quarter, statements, with for were we our – through have accounts sales the though material. Dialysate of previous targeted consistent quarter realized with our
Triferic in the stages that in our plan much and Dialysate very executing of our strategic XXXX are clinics is target this with early for priorities our of of we're the initial still phase. one commercialization group We're top for launch engaging medical and confident dialysis we and on appropriate
medical Our increasing and and pharmacoeconomic remains of awareness to drive XXXX to understanding plan Triferic’s medical potential advantages. adoption education by providing and providers
on centers a launch in sites. U.S. sample excellence with and is approach initial of Our of Dialysate phased our an Triferic the focus
organizations for more site with or medium-sized plans independence success LDOs, and working we're or small our to later. multi-site that MDOs independent large on actively has sized dialysis come single initial and organizations, accelerate Our or dialysis and from chains adoption,
of share the we're let the early from Well, feedback adopters. hearing some that me
ferritin is for QX the from levels. First, the results in XX% of renal important without of clinics exceeding X,XXX. have of light Spherix anemia Triferic survey the survey expressed feedback of recent above level appreciate become XXXX, ability that which showed U.S. notably The dialysis ferritin hemoglobin and ferritin approximately that indicated especially which nephrologists levels XXX patients levels concerns median is to survey concerned maintain about the XXX. This also ferritin nephrologists at increasing half
administration contrast of deliver with enough powder third, to customers up in because bio bioavailability single patients IV with available in result convenience buildup other traditional tissues. iron iron Triferic Second, the patients of packet patients iron nurses XX hepcidin significant to IV And Triferic liver a of inflamed to reduction freeing the challenges deliver for iron noted in can nursing time factor this even face clinics inflammation. and more have their with spend in time can because to iron our praised a patients. and can Dialysate iron, And Traditional the the associated packet of block. the in the formulation in
roughly haemodialysis Triferic are previously as to as to encouraging This we sales centers believe months and sales three slowly. four and is positive indicated the developing anticipated response cycle is in
transformative within haemodialysis step. the arrangements. to treat in As with interim our some an the clusters cases, in therapeutic in haemodialysis their any out of we mindsets, XX% we've that and medium-sized approach, are in senior some of take all as dialysis carve protocols patients time organizations to product, commercialization phased centers with for engaged we regarding discussions their U.S. Furthering independent these level system-wide within discussions the Though organizations targeting And together clinics. dialysis behaviors their are medium, of roughly it and customers will small change centers smaller
compelling these that with customers frequently and end, requested to to believe Negotiations driver process real data we future we item and with larger the by have will world these that is And are accelerate chains one of potential more be initiatives yield we numerous which believe adoption data, complex need providers. adoption. we a the will
that of chain use receive during Triferic we in we've entered program mid-sized data received we sample in from a are their forward. to dialysis of data First, analyzing data. report into July to the with and process the going an that pleased agreement the and I'm
the program from including to a participated that in working other sample institution. leading Second, clinics we're attain data academic
re-analyzing our as can useful our Triferic to the increase approved previously IV the that if next expand data sales U.S. for introduction following and completed clinical are patient dialysis Triferic move the we pool we a include could from four we And trials perspective, discussions large this we fold. Third, forward the to in of for with from potentially information focus plan provide believe MDOs. organizations year
Turning reimbursement. to
within issued the late unique into for This And J-XXXX As discussed would went will which finalize J-Code, if the existing last bundled the Dialysate for ampoule from be the CMS new recommendation, in effect separate Dialysate it's reimbursed preliminary hemodialysis. and Triferic CMS a quarter, version J-Code April, powder a J-Code, establish Triferic Triferi. liquid packet. XXXX on J-XXXX Dialysate July for Xst, of payment
completed filing formulation Assessment Triferic. a that we're for equivalent to of with may of recall now you developed May drug XXXX. we on NDA PDUFA adult or FDA date submission new which of for patients to agreed the In Triferic the accepted for FDA, Let March application of turn pleased approach the FDA Triferic Triferic and to a our formulation the Protocol hemodialysis acceptable our the IV SPA pursuant Xnd an that IV was August And me as review. be through would XXth IB for Dialysate Special to
to randomized data by XXth, of open the dose to January was quantity a the IV year. administration. between policies which payment update from Conference system beginning IV preliminary the rule results study, to doses single equivalent of Dialysis Xst, as our and issued label conducted and under supported this payment at that same or of Triferic is that Annual An NDA ADC XXXX. Dialysate proposed this multi-period study does the ESRD study formulation. delivers patients proposes presented of March And we Dialysate equivalence July The demonstrated iron Triferic in rates the establish On CMS prospective
the qualifying the the a reimbursement drugs Transitional of if Triferic of an add for requirements proposed to TDAPA which program of drugs. Under be rule. our has potential Pricing TDAPA revisions contains to excluded prior drugs TDAPA, certain for TDAPA we've IV types the received eligibility ineligible It on be to fall FDA XX, would effective under while Add the two for from CMS official category NDAs of Adjustment And XXXX. as the classification classification rules for January each years to for into provide the revisions of or yet by the from finalize approved FDA On under proposed code proposed NDA, certain the would new ESRD specific NDA the not Triferic NDAs Drug
of becomes around through any manner on the under it proposals XXXX and proposed are in preliminary available would Triferic innovative. highlight fact is in data both rule the value distinguish with current CMS And of particular FDA's we the classified represents. drug in If not our for that that is codes state care. accepting to other the extent and believe the Triferic CMS it classification the for standard the procedures IV similar of a innovation TDAPA a not and from is the XXth, policies qualify types, plan in that or engage rule. outlined to September therapeutic codes attributes Triferic the NDA as excluded indicative now or comments the We NDA notably additional of
While stated price bundle of previously remain enthusiastic we're we eligibility. the analyzing based longer Triferic based and it impact is setback. a has view on even peak the finalized in CMS near-term about opportunity would as see price the that doesn't sustained for Triferic’s market an market mean higher TDAPA if reimbursement term of within on the assumed TDAPA, this States, which change still a on rule the and United as It and our without proposed what future not
clinic not use we proposal must home, reimbursement dialysis in potential home of iron used. ultimately the alternatives beneficiaries of believe has support made use In not Today to to and go patients to iron. be as for July, preferable Triferic into new is renal and CMS this to and home and indicated a anaphylaxis providers currently intended home in-center disease. the dialysis Triferic while IV environment convenient IV due alternative to generally greater be for Both more dialysis the as risk end-stage transplants hemodialysis, could receive in available the to a Medicare among and have transplant also healthcare with incentivize commonly they're kidney on patients but released
are home for Triferic evaluating We our of regulatory to development actively various progress strategies use.
priority many global large with the IV or expand of our and and presence we're these used to markets to Turning Developing and easily a cartridges opportunity, like integrate our dry their protocols the so the existing market significantly. Europe In bags China, in us progress. IV Triferic. good will Triferic dialysis market bicarbonate stands markets making formulation potential portfolio is centers for
completed As announced our Triferic in China, morning, studies Biopharmaceutical results. this of pharmacology partner with Wanbang positive two recently Dialysate clinical
the schedule the a the are approval. next results these sufficient studies Wanbang of with equivalent the as from With regulatory whether the be in to formally in to step CFDA determine hand data from study will China NMPA a encouraging to filing for these meeting pre-NDA known support
in sold a goods and of Wanbang manufacturing and China Triferic for market to is and commence the world as in for that million retained China upon Commercial over and XX% up regulatory of milestones, next the price entitled approval. including an become sales following mark-up in responsibilities percentage licensing the the sales in several China. $X in we're expected of based clinical the transfer regulatory incorporates activity Wanbang our to And payment cost market regulatory with would responsible we of net range. this the is part approval to a a years. of ESRD cost agreement and to low-to-mid program trials of Triferic $XX million approval regulatory China milestone sales largest for
in market market than advance discussions. opportunity actively million in as with are application country our ongoing approval help Triferic our future. for IV near potential $XXX a more partnership we're confirms Canada discussions of Japan, the submit penetrate that In Europe in partners market. In and regulatory us total we that working our just to that expect completed well we for In research to can
agreement for for X.X present, sales we of is relative new DaVita accounts to contract of The concentrate as is and contract our business. the this important us forward share our for roughly The positive increase a concentrated which extremely as lion's price at represents recently still step a year DaVita. this at a previous finalized with half our concentrates to contract our contract sales And point. includes business,
the to to NDA milestones the that we're In and U.S. We profitability long-term critical abroad. launching both formulation. most second are enhance IV continuing Triferic the customer for of believe to we a pathway our business and sustainable base two Dialysate in summary, identify extend to our additional and ways we're the growth. our building the We hit quarter, in submitting steady pleased
the review to now I'll quarter Smith our Angus to over call CFO, Angus? second turn our financials.
