Mercedes. Thanks,
me in witnessed who today and hard-fought to been pleasure future have team's extremely couple our of important all following about it great sight. and have you those years our gives For you our an past story the catalyst talk of over with Akebia's efforts, to know
oral inhibitor, to PDUFA date, away. a user for to set treat months disease, goal That's X of vadadustat, CKD, chronic than reported, patients or kidney or XXXX, due the in on less date, we've FDA As anemia March XX, HIF-PH dialysis. our fee
then been Type dispute during resubmitted the has We with for of A working an end dispute We and U.S. approval process in for NDA the FDA diligently vadadustat formal vadadustat. meeting. team September. towards to engaged our Our completed the
patients Based in has the review data on resubmission data Our Today, they assigned years. post-marketing FDA actively X-month vadadustat line and cycle safety market the expectations. included where on than with in Japan of thousands our resubmission, engaged for X a more the new are is of the and the approved from prior in tens review. been
had just having I and Week last I meeting was I products of the patients these much many the physicians Kidney where experts, to greatest can of kidney very and is happy HIF multiple CKD. I can since including American excited with with in see They the of research. pleasure returned from say as as key conversations for need exists happening introduced for Nephrology areas the Society about innovation patients patient medical how unequivocally disease, thoughts year. well last are vadadustat role future with the were play that to share excited very week. on the treatment
vadadustat in broader treatment partners alternative to can the confident we're as community. on benefit patients. If bring we're eager deliver our patients, kidney and path to in to the and approved, to part, market the believe an our to continue For our deliver vadadustat commitment oral to forward our in U.S.
in instrumental in Japan. data Mitsubishi their our or the to Tanabe FDA vadadustat speak and of timely typical their for markets also the in as in I part safety again who potential and year interactions completion post-marketing collecting the was want in Japan team Before opportunity I productive resubmission. to commercial resubmission MTPC, I to thank over applaud regulatory Pharma for of the the the our the want past Corporation, U.S., included partner, vadadustat vigilance with
next expect vadadustat the to in the Now now that we're resubmission vadadustat our shifting focus mirror, we our is if regulatory year launch approved. rearview with phase
international Work Europe vadadustat Taiwan. market our call, potential Akebia. Australia underway has is the which royalties will approved partner and by been vadadustat in XX In for XXXX, future in last to Vafseo, in is in vadadustat, our and generate approved Since Medice milestones countries. markets, to bring
vadadustat anemia. That said, XXX,XXX the on care. have injectables opportunity. would treated standard represent most with the XX% agent, that potential market a ESA, we target our U.S. approximately erythropoiesis-stimulating commercial the estimates approval, that of $X approximately billion an be would dialysis are These launch of With are patients or of significant for to the on an nearly based
important contribute It's identified potential launch highlight already our a will tailwinds important to that we believe success. well to prepared and for we have are
ready we First, post supply potential final label awaiting go, have to our commercial product approval.
calling have Second, a on actively is Auryxia centers. commercial dialysis prescribers approximately potential experienced vadadustat also there believe an overlap prescribers. organization XX% and sales between We we
small- also we'll which the Care CSL with and of providers. XX% to through our treatment collaboration Importantly, potential access benefit partnership other Fresenius Medical with from medium-sized Vifor, enables its and centers
the expect investment our invest opportunity, initial in the launch do vadadustat to existing expect incremental that be our XXXX we we appropriately significant infrastructure, 'XX current from reflect on our While to OpEx. and in based preparedness to to compared
innovative transitional an prospective for that TDAPA. as to treatment the in the To anemia. used unique payment made payment Included or dialysis part CMS for providers. payment of system, manage in add-on promote payment also understand landscape bundled most patients treat critical in in U.S. use adjustment, implemented patients used payment the drug to it's ESA to are to a are dialysis. funds a Now Medications reimbursed bundled
payment The prescribe post TDAPA the overall their X of a bundled For TDAPA years would cover cost change. payment the designation, vadadustat does not product. if physician
that work payment there almost current patients treated for recognize continue payment policy, are to post TDAPA Now are anemia of while XX% to anemia. today in important dollars treatment and dialysis for the of it's the on significant we bundle
to 'XX, and the widely application expect would and complete have a minimal be anticipate X-month commercially anticipated be first be but patients. We October the quickly following revenue accessible reimbursed process vadadustat those of available to generated to approval to After product initial expect potential available by in month. TDAPA we
up our profit Akebia which As Vifor's economics profits. will receive sales contract. and associated vadadustat access in Care a Kidney with with sales Vifor potential to will our have of of collaboration predominantly CSL Fresenius X/X provide Akebia keep to not of earlier, several XXX% whom net I the will in costs, mentioned DaVita. will covered with dialysis Vifor they tailwind the with and we the retain any midsized to prespecified those certain through to the small- from strong X/X XX% market will providers centers, of markets by contract, of CSL relationship, Akebia
supported million this we the by flows cash product around for million $XXX through launch Auryxia come We've revenue net third product Now million $XX.X from Today, robust million. the $XXX Auryxia. net in guided we're be in to and $XXX will revenue also the fortunate year, I to quarter. reported to expect of
as interest Auryxia in providers XXXX vadadustat, exit contracts, expand expect learning in grow if revenue payer to broader We incrementally access it's and from and commercial to we our approved. unfavorable about their footprint gain medical
growth invest Lastly, us we XXXX, associated opportunities were which payments vadadustat service as as company. other able October flexibility to well additional debt of delay the provides until the the for launch in to Pharmakon with with cash of our
turn revenue Ellen? financials, like Financial more now over And Officer. and to I'd on Chief our to information other call Snow, to the provide our Ellen
