for Thank you, Thank Good us. afternoon. Paul. joining you
Medical Officer. me and call XXXX. productive Ray We Klema, Chief today our Officer had Financial is Dr. President Pratt, and the Chief our a Tom with On Vice
the also and performance; million you important for up Net drug year number concentrate from the due lower, updates financial lower year’s was $X.X have million highlights profit loss versus million was $XX.X few costs million. $XX.X this a sales increased for to was gross $XX.X product We profit. of X.X%, today. A were
So let's talk Triferic.
As as at know CMS, meetings benefits Services, and we last the submitted a to provides from Center providers. the at for patients, the Medicaid Medicare our significant Center and their Innovation cost Triferic you and savings Triferic the Medicare the CMS we for update, prepared well with with request, Medicaid proposal dialysis CMMI. improved and had And to as Medicare to also clinical Innovation, Centers that and highlighted productive delivers
and better suggests have shown clinical Triferic life blood patient will that delivers improved iron medications Triferic. things also bone will outcomes patients. patient among related hospitalizations, in infection has sufficient and data other in quality the iron, analysis receiving for Triferic our that part reductions protocol, $X well the from their given come cost billion over per concluded would treatment would Medicare if hemodialysis of that is were that The recall in patients XXX% shows that significant be which Clinical hemoglobin a and to You'll responsible and savings when transfusions levels clinical HD their evidence intravenous marrow Medicare these of reduce as by of year. cost maintains
reaction clinical improvements many was indication. to the not approved indication iron have clinical are Triferic fact cognition. replace states increased is this no administering reported treat and hemodialysis data the fatigue FDA the single that other indicate only to There Triferic maintain hemoglobin. the results to therapy and debilitating In the experience approved are therapy patients date. improved energy has The with from adverse that from and Triferic patients suffer specifically and in that FDA anemia that clinical and symptoms data been is facilities that a
been reimbursement a It separate this key personnel. main for Since key one to broad of in available for other have meetings dialogue and has and reasons pursued initiative have our last influential from make position initiative is we Congress support Triferic Our further the goal agencies. is productive all to Triferic we significant of and patients have the company. agency It and we have to my adoption. update U.S. it in with continued
position outcome. follow-on be assurances positive been has requested information we there have while of that no to into and We provided can a have obtain we moved success, believe
Our reimbursement working this time. of request at on understanding our CMS for separate approval is is for Triferic
are anticipating patients will we the you more we provide have we response. but that with will the it. wish I timely get date to and update a When now hear In don't We promotion active. I meantime, response remains we for simply very you. our Triferic a could providers
and nephrologist benefits Triferic’s ease-of-use the key dialysis and nurses, and We providers to and clinic. continue personnel educate its in introduce on
Triferic We if by very clinical reimbursement, that drug to broad U.S. providers by dialysis and is will feedback Triferic’s the its and economic incentive. positive. anticipate benefits be program Triferic benefits Our when expanded and continues adoption demonstrated cost-saving clinical sample occur on separate driven and receives
redundant and and have set. place distribution API is finished manufacturing We in packaging
which to is treatments annually. about prepared entire the market are XX supply We U.S. million
XXXX has the recall review our worked re-filed sense may since past as during do FDA FDA and submission issues. last this drug concerns submission outstanding requests review. the on submission. or Calcitriol time post-approval you have our on November We the with FDA this any the have extra our that We requested manufacturing typical update, to not Regarding
the know from market. Our market their have the we that shortly. excited they We're We the all demand about we the need should decision information Calcitriol they have and opportunity presents. agency have understanding for that that
for we and produce continue agreement within in our to we two fact, Peru know to provide with we Triferic last the progress, Peru first XXXX. quantities, anticipate Triferic is expect part Updating Europea. and it in for license active market we let in annually. required had Since market they considerable regulatory Once company categories two Quimica commercializing approval approximately patients have share. clinical In they maintains sufficient supply the nearly and is when sales want manufacturing have order customers we receiving not devices dialysis exclusive and drugs to some and we've and development available. a hemodialysis an hemodialysis nearly last of only XX% market distributed that business for XX% us Quimica does sizable globally. XX,XXX Peru The our weeks registration the we gain it signed process distributor all share There are of studies, and ongoing becomes called of can X% products additional when update, require it’s be updates grows and process in will further them. control
commercial are preliminary not only focused IV XX,XXX Rockwell. with France We Peru first annually. leading [ph] The discussions sponsored Nephrology more part due there the a representing than represents market executed one Chinese been patients be dialysis also in Europe. China Germany. a guidance. HD going where market oral the process XXXX We participating are our XX,XXX distributor products. for active to be Chile company enter diligence We active enable a in to are continues and discussions. Triferic and represent guided does Malaysia, BioRenal before Association There estimate signed have Chile to rates. on has and distributor Triferic next nations we clinical revenue year. in in upcoming drug with ongoing remain for additional now [PDAs] in present Chile in to in receiving deal an may in Chile Arabia growth the BioRenal. the Both we'll exclusive license Triferic manufacturing also also the discussions and Mexico, interested the eight the on within to current and supply this regulatory but have study. on are China our and track HD been partner second Saudi called registration begin is the posters grow devices We're Turkey, of opportunity We XXXX clinical is Nephrology commence studies and and for clinical approval expect our selling Japan, patients This Congress remain starting new to been at Chinese opportunity. in and had Triferic three XXXX. which expected hemodialysis Canada significant for GCC timeline of require is of half to has South start we the needed. for approximately as iron will Canada benefits presentation [PDAs] by company has Chile In Brazil, process Pakistan, for accelerated opportunity at counterparties X% drugs and which mid-XXXX. and and Asia-Pacific second QX parties commercial half meaningful patients. a also We ESA India, exclusively market is is Korea, weeks. agreement the double-digit and enter We the Russia, believe by in [ph] and market market The approached revenue
some passing radiological with smaller depending portion progress, X in in new of we by on centers device for product the reviewed receiving of premixed containers. combination using premixed We've approval the hospital-based product delivered available We anticipate for pipeline Triferic premixed liquid which Triferic track that year. for we sterilized this for filing widespread the units and those treat directly combination of approval IV quarter this IV devices We the Triferic choice we're market be currently the cartridges FDA, infusion and clinical on solution our which receive a year. This clinics XXXX Triferic blood equivalency and make to quarter rely however health is of second FDA. the the in Europe is enables and to product of also completed for Triferic have with the clinics also the drug IV the to anticipate time and that's in patients our could and been late patients. in second infusion acute hemodiafiltration. gallon infusion a discussions and bicarbonate a of FDA mid-XXXX, of into product with as we bicarbonate dialysate [SEDAR will stream the be the the to development from compatible will clinical submission products H] clinical be product in regions other solid our Regarding presentation on this study FDA
to year-end. review expect We an approval by
Triferic the commitment requirement as known Agency and Once expect the are the study in program to for in plans weeks. We've is to we a the FDA to and pediatric next submitted we the clinical agencies, European this plans in EMA detailed obtain U.S. both to clinical marketing Medicines proposed Europe. the X plan for initiate the study both agreement accepted clinical application by later a the Our the year. postmarketing X and regulatory
dialysis our good or and initiate to Regarding to first PD correct study, PD further blood. peritoneal transfer this QX PD Triferic to the results the showed plan Triferic year. from of dosing iron studies in in clarify of from initial We fluid patient fluid the
trial Regarding activities, anticipate approval March or clinical China application in in our ex-U.S. April. early we late of our
comments approval, plan of week We're the and have to to patients. to Triferic met with ago we just them the month. pharmacokinetics final this advice Chinese pharmacological Triferic discuss program. confirm initiate two the CTA of clinical Following EMA by studies end filed expecting proposed a In EMA we scientific with the we from Europe, clinical in
plans Europe and for have recommendations. once agency's the reviewed comments our we update will We
data a Regarding be Shohl our orphan required a will Triferic suitable suggested of the drug find for oral bioavailable the administration. from solution IRIDA additional form program, Triferic of formulation to work administration oral
the the We for immediate thank the have parents patient study. clinicians, do plans work. in to and that exploratory no in the her We future participating
Lisa larger practices past natural week, Directors we Board and to the the a shareholders Board. We’d to a for enhanced Colleran of development in we is welcome enterprise. become both commercial and progression as this for our Wolin our Lastly which Ben like of Board a positive our
as responsibility for value shareholders make building the remain I will primary think seriously. very a welcome both will take be we of the company. for will driver additions every Shareholder our value decision
believe terrific our Calcitriol. manufacturing be have commercialization time the a of progress scale of at We of front value will for half great in and us a back creation of Rockwell and We with opportunities of XXXX Triferic the broader shareholders.
I’ll discuss call over financials. the to the Now turn Tom to