FGEN - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the FibroGen Third Quarter 2020 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference call is being recorded. [Operator Instructions] I would now like to hand the conference over to your first speaker Mr. Tung. Michael you. Thank ahead. Please go

Michael Tung

Robert, Vice and at I'm you afternoon good of Corporate Tung, President Relations Michael Strategy Thank everyone. and FibroGen. Investor

to our collaborations Pharmacovigilance. Chief Officer; from Carter, on regulatory Enrique Financial Pat Officer; Enrique include me about call but our Executive Yu, FibroGen. initiation Chief our like Vice the Officer; update Form found Form and SEC Senior the Chief our Chief FibroGen's like publicly FibroGen Wettig, the clinical at commercial Commercial would to I a design And Medical certain those up Drug uncertainties The of financial and not Joining remind be to section Kouchakji, press reporting Operations; Cotroneo, and result include, Such our XX-K with are you Vice and statements and that our results our limited to forward-looking material results of Dr. statements, from any filings other statement. includes strategies AstraZeneca business materially related open potential today's statements website statement of China for prepared and Investors and would that may made Peony trials; found our Chief Safety Pat and be Officer; subject call, results undertake results information to Chris recent which our today's Percy and future Astellas; will to risks as more XX-Q. that could events call results of and our business for CEO. Thane and financial our format Enrique and guidance; over of any webcast today's President projected forward-looking can in Chung, the call I in today's Dr. a with to turn of our forward-looking business The events Scientific we and results; conduct call Development, most research President release differ Dr. operations; Officer; FibroGen's risks actual Conterno, www.fibrogen.com. Senior not otherwise. is matters. of Conterno, Q&A. conference update including or our Clinical remarks Each other does remarks development cause description A risks and obligation are of and can complete new after activities; call enrollment these whether our on the with to that, on regulatory Elias Enrique?

Enrique Conterno

the call Nephrology of will after and and review up recent your Conference, Today's on our include programs. from data clinical we developments our Pat to the and a last the high trial our continued months. China American accomplishments then will Very of few will bringing the chronic to the roxadustat level results welcome good. medicines and today's progress third most afternoon making our patients our suffering a from and the on the conditions, and life-threatening presented challenges potential our good despite call. high call Thank level quarter the by Mike, by important XXXX you of summary first-in-class We're earnings pandemic. begin to everyone a will strong COVID-XX to commitment Cotroneo, questions. strong Society call financials, which providing I review CFO roxadustat open from updates

we to data affecting of of clinical our condition millions which had efficacy established XX in highlighting at need including the for Together need profile the alongside with body the get of the analysis The we roxadustat's presentations patients This Astellas, recent Kidney with the to safety the anemia patients ASN foundational first-in-class with year adding CKD and and XX of ASN roxadustat of our -- partners and medical our investigation us presented roxadustat for let safety on add unmet anemia oral, treatment results and oral anemia, with evidence started consistent patients. CKD. meeting. and So new Week understanding AstraZeneca of this demonstrated as of continuum roxadustat reassuring across unmet treatment potential efficacy CKD. partners, a

on burden data options presented are also We a of these the needed. new CKD, anemia of that patients for treatment significant reminder sorely

Roxadustat major were for populations, risk On incident reduce cell diabetes, of consistent a than non-dialysis-dependent, important maintain levels of anemia and greater the transfusion front with in this to risk XX with of increased those systemic inflammation. consistently suggest And the than from range less including versus vast transfusions, demonstrated above improvement hemoglobin wide a a patients in majority a roxadustat ability patients. trial across hemoglobin and dialysis-dependent clinical peritoneal dialysis demonstrated And red hemoglobin patient of included The risk XX that efficacy statistically heart CKD treating failure to efficacy in results treatment. data blood to with is and of the in XX patients. analysis goal the significant the significant patients levels the measure. dialysis, regardless fivefold levels in four

XX XX. and safety. who explored achieved with hemoglobin levels. cardiovascular lower of post CKD this MACE+ hoc rates who achieved late-breaking of of outcomes abstracts MACE+ patients MACE Two patients treated above anemia below levels roxadustat, rates including to than associations had of and In at hemoglobin hemoglobin rates the Moving with analysis MACE various patients

of rate analysis of dialysis-dependent showed alfa. hospitalization roxadustat a Another compared with in lower patients treated heart for epoetin CKD exploratory failure with when presentation an

ophthalmological widespread the effects. Conference transform top XX roxadustat of neoplasm, the roxadustat of XX interest two. We Finally, summary, appreciated highlight with ASN multiple the viewed patients presentations the top posters CKD. with including reinforced hypertension a potential of profile the of to roxadustat's for was a treatment anemia In safety with and to related

by the quarter. to expansion We're increase in listings sales second hospitals Hospital hospitals. and the continue China. of to our enlisted which driven in roxadustat the opportunity seeing anemia to the of now in we're both broad versus key representing roxadustat pleased China, at an XX.X% is million the In second the as XX% of listings for net hospital third with an uptake, Moving CKD in China. of Notably adoption report market is of being quarter end at end third of the focus in efforts. XX% quarter, approximately This comparison the reported listed be a of was to launch $XX.X quarter.

in with significant across as anemia roxadustat We well initial dialysis This as in making broad patients. from countries. for respond range provides roxadustat who U.S. dialysis as do not And standard within important the roxadustat continue goal utilization to to forward treating and hemodialysis our dialysis. well well of long-term CKD. CKD been utilization between to look peritoneal two-thirds We long-term on China's of pattern of of anemia to hemodialysis, prepare other patient and About adoption advance you different see ESAs, populations are patients the instanticipate of and split care we the patients in keeping updated roxadustat, success, we bodes learnings as launch has patients.

Let regulatory us the and roxadustat. preparation commercial for review turn U.S. now to

comments discussed FDA. We are and with working the will be be FDA. And the closely on AstraZeneca on to making the we we with the launch engagement previously, interactions of ongoing preparation pleased and continue U.S. as have not with cadence activities. We

apply the TDAPA, payment PDUFA is to would launch the provide a system positive roxadustat that within of for And XXXX. of occur, a The the for dialysis-dependent outside commence. the December or adjustment, for date plan by coverage immediately roxadustat official drug XXXX, Assuming should TDAPA earliest transitional prospective patients be the receive would add-on would reimbursement which decision dialysis payment bundle. could April X, organization

the the XXXX. approval, will and is Assuming are under second launch quarter way. of dialysis-dependent XXXX, quarter This awareness be roxadustat plan activities in first officially and with available to of non setting a discussions in payers in well we

the Phase have publication, manuscripts them time trials and pooled data III of sets, have We data for expect covering submitted to the and individual at for the launch. both

we not large in of year-end. In of the adult the dialysis anemia CKD, in In ongoing for with trials IIIb the on with clinical in and filing under roxadustat two Finally, the for patients and is on review, to expect continue under dialysis Agency. European our for Japan, Medicines CKD roxadustat patients filing to dialysis indication Phase treatment the decision U.S. by the providers the Europe, dialysis, setting. dependent both is continue review on non-dialysis we anemia by sNDA work

conduct now the situation would will Starting pandemic roxadustat. of clinical our Moving the the I our trials clinical like present to take we guidance and our to pipeline, to actions time continue for with as necessary. across that and provide monitor industry, trials. to continues challenges to note line COVID-XX Please

data line or half our we first Phase trial myelodysplastic top For syndromes, of MDS, III in the XXXX. in expect

if of program. initiate or CIA anemia, the II our to top we successful, trial data quickly plan half we For chemotherapy-induced and in III Phase second line in Phase patients, expect XXXX, a

to pamrevlumab. Moving now

the months, mentioned extremely severely have of and to ZEPHYRUS-X. of our situation compromised over continues delayed COVID function. most the trial initiation continues patients we of we has due vulnerability be with ZEPHYRUS lung the be these paused which enrollment, trial IPF As enrollment, in also pamrevlumab's Unfortunately, prior current to the challenging affected to the for

will on not we at and providing IPF guidance in be As time. pamrevlumab but DMD, for such, this LAPC

trial the and enrollment scenarios, appropriate you will of III COVID in plan half XX In muscular non-ambulatory in different dystrophy pamrevlumab line And and the IPF evaluate lines, our second the projected to patients initiated is update time Duchenne in data we a approximately variability we Phase we Given at XXXX. August, there top or time. expect, LELANTOS continue to with DMD. of

trial patients ambulatory a to III second DMD. We LELANTOS-X also XX initiate, plan in Phase approximately with

unresectable remain for of expect of III restriction on accelerating second ongoing trial we of data clinical our while Finally line trials, ensuring our half locally XXXX. the in all advanced Phase enrollment patient We cancer, in safety. top LAPIS, focused pancreatic

now review Lastly, CFO alliance Officer, just business to me. our Christoffersen, FibroGen, to to will for and Kirk the and Pat? over call Chief financials. joined as who management responsibility Pat reporting I has turn development with the to Cotroneo, I want welcome Business

Pat Cotroneo

Enrique. you, Thank

certain for million to AstraZeneca, of $XX.X and third revenue, net of product of million for million for current million revenues sales today, XXXX. bulk million the $X.X to of sales roxadustat $XX.X The million of announced third drug in for for total revenue compared net the was revenue As product in $XX quarter consists $X.X quarter China, reduction XXXX, $XX.X quarter of adjustments. as a development

For quarter the million $X.XX per last expenses income per share, diluted million year. of million $X.XX the and and $XX.X and $XX.X and loss costs and or $X.XX operating to diluted expenses compared costs share for $XX net per were million, third and as basic was net a same basic period, operating or $XX of

amended distribution, economic provisions were value ways, payment China improved As costs on entity was our aligns AstraZeneca. a an call, to we sharing both amendment, amended the mentioned settled to time result economics the profitability of new will and marketing Under equal The profitability and through until XXXX, deferred a AstraZeneca expenses certain AstraZeneca. liquidity expenses. and these the AstraZeneca We collaboration FibroGen. Historically, franchise, of co-promotion and in co-promotion recently losses parties and we to well conduct expenses. joint quarter's predictable for the of FibroGen co-promotion optimally and the our establishment that more that more and met. the with in perform made completed distribution also including agreement sales establishing roxadustat for and as Beijing of reflect in and At of this roxadustat maximize were FibroGen historical in cap billed marketing will and the collaboration number historical of FibroGen the adjustment last an amendment, both as sales September

non-cash reversed and better recognize recognize on entity, the the the customers. $XXX.X an expenses time. profitability time in of the for selling, the to compensation approximately interest of $XX.X operational, had non-cash distribution million quarter aggregate a million in million, to is at a expected is of XX, receivables. expense result consolidate sales This to the portion million, entity totaling its distribution period $XX.X million AstraZeneca we which which reduction cash, to for expected administrative of in restricted were and China a an parties' result as roxadustat to was the to is revenue is aligns the $XX.X As based on costs in expense, amendment compensation third revenue earlier of while commercialization At million enable expenses, distribution to in and and compared expected aggregate September Included in XXXX. fully recorded $XX.X deposits, co-promotion stock-based for investments year. was entity these expenses cash result quarter of same prior equivalents, as ended stock-based of FibroGen changes, of Once FibroGen point an September which operating a XX, and general was portion XXXX sales $XX.X

million forecast over would on we turn estimate cash And XXXX a now deposits, in between At $XXX receivables have our now million in data, NDA of we anticipated our milestones changes U.S. Thank this cash, and nine of mid-XXXX. next the U.S. restricted over in $XXX EU like to Looking range to anticipated assuming Enrique. now XXXX. expected no U.S. approval million ending Based first ahead, for in be and months approvals expectations point in and the have we total and call potential time the time, latest investments I to in milestones $XXX in commercial equivalents back QX any the the sale of you. to

Enrique Conterno

summary, is to well in positioned in to the And environment. you. continue FibroGen current progress Thank make

continuity progress and effect we're seeing environment. -- current in impact plans business are the some in Our

effect plans operations seeing impact Our resulting business continuity are we're and some COVID-XX. in to from

We resources have the capabilities stated navigate times to and our achieve these goals. uncertain through and

position sales with commercial all and $XXX As at all strong approximately commercialization for approval $XXX these roxadustat is a and over we with months. next the total our the We in XX/XX AstraZeneca. reimbursement received the in third quarter of China, expenses full cash expected of in roxadustat development end geographies million of where nine China, except first shared sales and partner milestones in ramp-up financial million

questions. position advance our looking and regulatory to roxadustat decision with to are in and cash year-end. could which lines by now open the research We for the excellent U.S. agenda you have development an if forward Robert, the

Operator

first Instructions] the Thank our coming line We'll question Michael from Jefferies. you. [Operator Yee of have with

is line Your open.

Michael Yee

implications nice I two about congrats was drug you've and while whether a box sure a for has the I'm do a to in guess Thanks part there or of very not. on regarding is I some implication they not. particularly question. an comments investors, And -- has a or this the the opportunity, a progress, black AstraZeneca morning, One whether had had guys. picture Hey, or drug use China. black thought this big box

idea run seems very having just And good, later how things relates what might And second question arms of presentation, control maybe nicely thinking on. summarized. the the maybe cardiovascular as course hemoglobin need trouble I Amgen So What you less to but to got don't you guess Thank of the the those mean. ASN then in the implication as about through which is up that that's you. towards events that cardiovascular safety? well? show goes And

Enrique Conterno

as question try try I'll Very Peony good. me And answer let address you, with here -- Michael. to try we'll Thank first question. the second the well. to

the In number you wish. now. we But -- about interactions there there with number can terms And warning, scenarios that if are number our or are FDA a scenarios. speculating of the on a everyone speculate box remind of of me are a of are planning potential to you comment just not what let right

that So take box box Clearly, what on the -- across maybe between the is. end, that a the on you the can differently other have. maybe can any of box ESAs no say, a one warning well that have Maybe indications. you like somewhere we bit basically little side, a warning warning box than reads warning in warning ESAs' box to reads

we in products -- the are a the and we I a clear vast having think dialysis when pretty those treatment that setting, products this, treated the for that today utilized it have we are is majority, think look through -- anemia being dialysis warning. when for patients in the box -- at setting As being first clearly

setting. not So not to -- the warning in that this comes patients but When particular in we are current -- being disadvantage of given box particular it's a a is better, setting, for having use, manageable this I untreated. clearly, a it something it as warning, So is setting, very box NDD, most right? the even we have having view

of the different and But we the situation, for trying of ensure having to are rates to basically to So build that market particular, able as uptake, being make it's a the out in these with one that more setting, to and treatment because would treat case increase value comfortable roxadustat that we as box patients treated an patients. be proposition in a needle compelling every get XX opportunity instead it's in physicians move truly uptake, that the slow can setting, time. the actually Clearly, the product. a utilizing initial over warning

don't the but see market being in absolute uptake frame we of -- term a about that the think some that down maybe longer it the issue, I slow addressable that's huge the term. So when near will

think achieved your the corresponding and are MACE I terms referring question second hemoglobin In we ASN and that data on to of on you presented outcomes. levels

increased. Just to rates X, analysis we at interpretation Rates of DD recap in saw this rates say levels MACE. our and consistent. consistent is, as NDD. MACE+ hemoglobin events. basically lowest quite that high And decrease data this XX, basically for rates was and hemoglobin of pattern And higher MACE of very what below This basically above we the of both was saw hemoglobin MACE quite

number III that basically should -- to one way. right? They -- just important basically think, It's basically post to a that because, the exploring think treat is to So analysis, of to is from we high be By we below this so. I me is But saw it that when I low treated. to And rates we we anemia. have low, I mind it's data, see that we for of are that need transfusion the keep this in way hemoglobin -- analysis the clearly, also increase trials, we Phase do number four and interpretation anemia analysis rates we -- intent analysis. exploratory hoc mining it take that data view as think rates need Our needs seriously, but that the of them let's so is see view we five-fold. XX, what should one almost --

So anemia treatment so is importance own doing and perspective. basically around the interpretation medical our of it -- from basically a of is

Michael Yee

you. Yes. Thank Makes sense.

Operator

with question line of Jason Gerberry Next be will from America. of coming the Bank

Your line is open.

Unidentified Analyst

our explain patient patients. taking more the today, help the in [ph] help Thanks Hi. you Can doubled to Fadia of you increase Based did market Can from This from but sales numbers on on China? dynamics XX,XXX -- is explain data AstraZeneca sales XX,XXX for Jason. for XQ questions. than from that the in to rise match number the that? not XQ,

Enrique Conterno

Yes.

the the Let me Clearly, at the China. to really And of year. China. QX, provide of are have to as Chung to help China And very ask beginning of we try on in with additional some comparable We launches, reimbursement launch. very also XX% I'm at end listed look going provide some achieved already commentary. then, the Chris color of we products pleased even quite hospital. as significant in are products extraordinary, we of become is that our This

that think listing So and signal it's long-term success. a is great I very progress for significant and key

our important, patients, also we Clearly, launching I across underlying now, Right for we be potential segments. that. opportunity fundamentals, long-term revenue think, think utilization look try the as a we reported of become, within that of describe, in basically opportunities million, very grow those we in aim be when to roxadustat the as them that $XXX addition I million we're business billion, think what I $XX.X has about strong. view so course, we're consider would we so significant that to QX, to In to good versus reported many as very, which that with that, we has $X.X towards would different product adoption consistent north $XX.X well the And breadth of the the see very blockbuster to able QX and very a China. I different progress. define us is to just hospitals. million success; in listed I at seeing And a to so

As to the ask were AstraZeneca, some the are understanding -- that were patients that but they reported cumulative that start your And as stop relates patients patients, quarter. -- to opposed treatment, because some it I'll -- patients to question, know, number by as patients there in my Chris confirm, the duration you the of treatment. of

of if the opportunity think And we benefiting the double going Chris, to will patients in don't I that But do have we calculation you so of maybe, increase that a we're So start be we we're number could comment? are just where roxadustat very to terms able in and pleased China. demand. patients and the many to

Chris Chung

Sure, Enrique.

to quickly So sales very the said, are supplement what report Enrique sales. we ex-factory

demand terms sales I what in actually to think and patient what's sold -- point more patient the the of is to prescribed. hospitals to actually

two linear know a of don't that I directly in could that So the we link manner.

in trying As it's can stage a Enrique said, this tells we remain a opportunity. to where uptake, as the early we're but we link patients, We're on optimistic are see it's At very demand track us new to about robust variability. you terms there's this ex-factory can, to number of there's some sales, there's prescribers DOT drug. our of but and but at best just still time, trajectory the what the of lot launch market very from the patients, tremendous very as getting difficult who new

Unidentified Analyst

Okay. That’s helpful. Thank you.

Operator

the Next of Annabel be line from Stifel. question will with Samimy coming

open. is line Your

Annabel Samimy

question. for my Thanks taking Hi.

challenges a that non-dialysis seems a of So how black you rather you expects about the wealth I it expect physicians population? box. you talk the do the bit can launch ramp notwithstanding the no to some hurdles the in expect how benefit you Given -- know or where have, hurdles, data primary you the you about be? beyond adoption understand quickly, or box expect Just reimbursement had black to like of I to build or quickly. little population, relatively a question that what AstraZeneca the trajectory. expect dialysis Can

some NDD of population? about the considerations So the thinking you're in are what

Enrique Conterno

different the two reimbursement to also are different, mechanisms. respond and settings they Clearly, Yes.

First going thing, to reimbursed. a I ensure think roxadustat need that be launch anywhere, is for we to

I've So, that in the we reimbursement NDD, earliest could the TDAPA discussion for payers. commented are need initial to plan our in that, in we part my we in we will setting. date I both of be as to and formularies. in of the work also comments expect X, dialysis on with get towards reimbursement April particular And need XXXX. the placed different this case formularies, be In case, submit think, to

will arrangements are to be make sure have able those we need So, made as and possible. to we want to arrangements that quickly AstraZeneca those be as to supporting

So thinking that not that's we is to as of are about there's just We the about that in time. to being reimbursement patients adequate just about, an part that important NDD -- particular think think need this it ensuring treating -- going case, over treated. about current be

of That need that of the we some some insisting educate treating anemia. comes the the of the to on it and I in basically when So to that's overall comments incredibly why, call. that on conference comments initial important this during are the is benefits, I'm the And we marketplace comments upfront. anemia made importance of

Now, number mentioned has benefits. you roxadustat of a as

catalyst course new those that, profile to ensuring up. be in marketplace. a of uptake seeing going NDD about prescribing patients that market. patients, more expansion today, right physicians, time, but only in we're appropriate is this the patients activation good has be we anemia patient efficacy roxadustat. able of are to over a the make treating that the or not able over setting a time. that that physicians we -- to be we And to have need to to that treating a the from this be overall scaler thinking and are to could ones that about -- expanding happen addition just thinking it think the be we So, we treatment option safety to really sure for We satisfied need be And that think understand need not of do reaching we're terms is But there that would to XX% going with to that that benefit and could yes, in is the

So, I'm look as in And in to successful, be we supporting if he and be going setting. any additional forward can we ensuring that we we partner has to AstraZeneca. as a comments. have ask can Thane, that great them

Thane Wettig

Enrique. Thanks, Yes.

now market, couple think of build. it When have as don't been as the rebuild because who think a We prior ESA the in an dialysis heard it treated patients additional are one was that about XX statistics treated. And about a the we in where, in patients the Just seven a being you've time, number with point an to comments. market think about previously NDD months it one we of not At about in are one about market with treated three. just ESA. of

way mechanism a with about much AZ perspective and ensure believe their to hub, the opportunity advantage AZ on working And so that, from patient that internal talked they have Enrique support the the scaling program XXX them a and ensure then be in rebuild kind an important a patients of support like which and is, scenario on the as we be of different as our can therapy. significant thing will market reimbursement And second to mechanisms in goal will first to in staying partner the place is have we well. the getting presence patient that with to affordability eligible assist

Annabel Samimy

Great. follow-on I Okay. just more one if could question. And

only building, going You get cash that's a quite better. bit to have of

the expense of tremendous a amount launch. have don't You with

So, out? just Thanks. programs? any thought R&D to things thought beyond Any need is to financing there additional your build business you development and

Enrique Conterno

Yes.

will thinking think we value think development bringing about this that start and earnings I've commenting business assets significant nine believe mentioned create for be at be I previous and on can for I be about by particular there an to signs months, able to but to going patients job or yes, something not months development, we're now been so my first as phase, way on So, initial that us that the I the think XX now shareholders. or opportunity business which and in that's calls after

Annabel Samimy

Great. Thank you.

Operator

with the question be Leerink. coming line Porges Next from of Geoffrey will SVB

is open. line Your

Geoffrey Porges

you, Thank A questions. the Appreciate quick answers. much. very all couple of

the you've timing I the could if thinking and on then this, for latest the and be next cancer launch helpful First, something about reduction And launch, Enrique, and is said be physicians assuming for then something DD that what study is to featuring? at the data you the time confirm is apologize, but secondly, just answered success lastly, you'll NDD potentially you specifically about readout? Thanks. or to what might pamrevlumab FDA? And the that that meaningful year, LDL pancreatic

Enrique Conterno

good. Very Geoff. Thank you,

first that LDL way Just we but think -- resection LDL And as expect line comes to When the When do at in the is mainly your to -- we second to we impact it end, about And cardiovascular or for was half mentioned question top expect a last that risk. entire is a comprehensive of and cardiovascular a LDL. a outcomes product. that utilized XXXX. question readout? question We marker marker certain nice to are extent, have, about let second was the LAPC. in me that, address about data your of we have

basically think data. that it's data showcase able have, LDL, safety but cardiovascular yes, to our even the to we LDL importantly, to it's showing I be So good in overall decreases have more

Geoffrey Porges

Okay. And timing two then sorry or indications specifically the the just for populations?

Enrique Conterno

to when the expect as would can clearly determining right, April launch X, we but for get make we earliest And approval, after terms Yes. be product expect official DD the two, we that of launch the are and we would XXXX. we soon TDAPA approval the both for in as because that NDD, available

we're the comes we products that's could. dialysis second for -- in incorporate When their what or what they quarter targeting NDD, way the launch be to the the the the given expect we launch So think really would XXXX. product organizations using they in that be the that's would that basically catalyst official to of it also official

Geoffrey Porges

very you Thank much.

Operator

Yaron the with be Next coming Werber question will Cowen. line from of

is line Your open.

Yaron Werber

good Hi, afternoon. Yeah.

before are it's run is you Enrique. typically So highlighting. of One I really on give they is clinics commenced you're do these and than those those you the the how would a have were studies before in been and have have a know what new sort then innovative the us a they irons I an and programs of will -- you. official argue you we couple ones. enrolling dialysis you can And a drug. program? sites. Parsabiv, or mid-cap not typically have but think DaVita drugs an in basically that Fresenius under TDAPA a argue adopt pathways but -- slow. you of just and dialysis long launches questions pilot better you Can And not With that it with adopted incentive the a pseudo was and small Thank couple big when they pretty or it and mid-chain big and they're different studies pilot even you've Sensipar whether TDAPA, out, And roxa? secondly can to historically and follow-up data, that? at on update of providers some profit look be Why

Enrique Conterno

we our Yeah. I'm which comments? Phase conducting organizations. Peony going to some comment to on like ask would Xb Peony dialysis with studies, you make are to

Peony Yu

largest of dialysis first be are will the and exceptionally to is half product. in in with to further the organizations we XXXX of working our study And our studies opportunity expected the And This Yes, are Enrique. are some organizations. studies an launch. support to be time the dialysis going for U.S. two Thanks finished Yes. well. the

Enrique Conterno

you're other that what terms doesn't -- examples. at I your And of my in But terms you looking will Peony. I a a -- question, right? utilized because having is it that be of roxadustat thank favorable favorable believe reimbursement of is if TDAPA, profile overall share understood we it offers, has clinical get will going mean not here. the reason scheme. reimbursement in And view you're because necessarily The to why use

we of benefits. So offers number that think roxadustat a

to in that have many patients very, cases. patients given candidates well off are we number we that -- dialysis, if ESAs think incident a Clearly with outcomes be not about in do showing are for I away. cardiovascular the XX% think we very we the there doses that's in of the see experience that those or China, right that we have on that roxadustat patients, patients would maybe would dialysis high We respond so -- are be this reduced of population extremely data also bat estimate basically straight about important. excellent in think in

the because a offers. going is or not to negative itself, I be So the important product that think economic negative risk – benefit I product a driver. that us benefit to in to incentive for ensure to the it's overall think profile TDAPA it allows used there's be and

it's driver think So the the positive product. a a perspective if reimbursement from use I anything of for

but look we would why of see will TDAPA, product utilized. the be profile to I product So not really that the believe to to

Yaron Werber

Thank you.

Operator

from with the be question Next of will Difei Mizuho. coming line Yang

line open. Your is

Alex Bouilloux

Difei. Hi, on good taking the is questions. you for for afternoon. Alex Thank This

given to potentially if to First of dialysis large that you to could would manner in a would guess follow-up. U.S.? large dialysis, two bit or I contracts market you contracts first following the expect them? just then you how with in of secure us a more with expect one in a will have on give you. be you're with one, the you secure providers providers staggered color or Thank And And the I approval, engaging maybe

Enrique Conterno

some X the commenting want we them them. not going Keep product to We're be Phase we -- utilization discussions broad. will Clearly quite we've that our make the where conducted we clear is to need closely been our pretty the mind our for receive time. with trials sure clinical we on providers. but it that that on pretty product be the approval, with in are with to working different Clearly of Yeah.

dialysis Phase studies the conducting this also with -- Xb are organizations. Xb We

profile that the feel health patients position. overall and it we organizations. I the so good we're once of we also a to of are what be So significant think can And care that offering. in medicine really from perspective to -- again that And medical is a value

are in we of we good our discussions. So in feel I think terms where

product not goal. as -- reach able TDAPA to the be try to intent to towards being getting that clearly critical can. be will effective and -- And to to offer is Our is many patients we as

Alex Bouilloux

Okay, dialysis patients you great. color provide conversion are patients let's another today seeing a of And say who in quick compared Are these roxa's could I'm six on follow-up, more question China. around from specifically just ESAs. bit to to stable a roxa you. already if a then bit you wondering versus Thank uptake on ago? months

Enrique Conterno

provide I'm maybe on going Yeah. to Chris ask some to comments that.

Chris Chung

look and uncontrolled and hemoglobin also of the peritoneal So controlled way with we maintenance dialysis market, and those hemodialysis. hemoglobin all the levels levels dialysis at is first

we and PD this at well It oral the to in extremely additive of We've population. the population. all obvious of first roxadustat. obviously, profile So to attractive The very for look done is speaks well reasons. PD the clinical feature, population administration

in So there uncontrolled different we're of `In for particularly HD, very uncontrolled a controlled. proposition, those hypertension well PD. is doing with hemoglobin -- value terms and

population. For initial the very is, target the those iron inflammation. and well speaks uncontrolled are on really to adoption and based differentiation that population a launch mobilization It

the And is So a of clinical see we early that's very, there the value proposition very lot where adopters. strong.

But the variability. to higher there the there's controlled of we the important treat. to a matter And so important as It's is We maintain, that population. into low target. are thesis ESA. pricing, than little it's important very are seeing treat migration to It's

bit the we're migration that and So focus, seeing into launch little the the is not but there but adoption. initial a we're population, happy frankly the see maturing different, value was proposition which to differentiation very with

So delighted we're that. see to

Enrique Conterno

not at what clearly this I we say, of think or brand that looking within I what could the be but the dialysis, the could think the at brand the really the and incident adoption in good situation could would dialysis end I you clearly see a be patients, patients which thing predictor great what is in last be the is, addition future. question, The stable did on ask and to

Alex Bouilloux

you. Thank

Operator

question We Beatty Joel of from coming final have the Citi. line with our

line open. Your is

Joel Beatty

MACE for the ASN, MACE how patients taking non-dialysis presented that MACE was mind, the ex-U.S.? that bit differences in showing outcome. really Akebia quite it was At Thanks for Vadadustat hurting Hi. in data a non-dialysis looks U.S. on better my their MACE ex-U.S. that patients, could their questions. enrolled the any U.S. and the in data with terms looks patients of your versus between I you guess characterize,

Enrique Conterno

Yeah. the to XX was is trial me make plus/minus in Maybe also, designed because clearly as a let know, and/or placebo. we treated OUS. you some just our we from of importantly one, U.S. bit were whether different going comments, in But terms vada little overarching relative it

roxadustat. for utilized did not the we So -- we treatment same targets

comparable think overall at look comes basically I to placebo. when what's is trial in -- to important NDD see were we the roxa, we that, we when when Now it first

it comes that's So when MACE. to

We our but the non-inferiority. trial an of first and the be is more -- the where comparison not to a will was Akebia of trial showed critically it trials -- post best DOLOMITES, darbepoetin most comparable to best is for against which that's in we would us part the which important. compared U.S. that active outside So The be study, at trial look conducted

by the of hazard on So in way -- hitting one, okay? that X.XX. saw hazard We And both ratio -- that's points. MACE once XX the and we saw we plus/minus ratio you're treated again, to,

very else I that. about want Peony, you don't know feel if And our to anything we to honestly good So data. add

Peony Yu

study -- which -- placebo had ex-U.S. said, XXX% -- DOLOMITES Yeah. Enrique that we that we ratio. MACE is U.S. in consistency reassuring consistent very And is is with Thanks as control program, overall data our in a program. our so Enrique. hazard the now Yes, the the with we -- that main and saw the in

Joel Beatty

Brilliant.

Peony Yu

standard. So are we we've -- that measurement you we that, is glad standard of chosen this and have for as know, high a And safety. a placebo

Joel Beatty

landscape. clinicaltrials.gov think And readouts Maybe the daprodustat. So on other time the recently also one sooner the on I It transaction. question lines for competitive GSK, for great moved is the the are November or differences like, XXXX April and whether for, to how your there there non-dialysis. resemble data, look consider? could for looks for dialysis could results predictions Any XXXX they

Enrique Conterno

them. I a good question think for that's

Joel Beatty

Sounds you. Thank good.

Operator

Speakers, any have don't We questions right. All line. the on please more continue.

Enrique Conterno

XXth much. for And our December the third Once here action we good. is course, you a We're of time results. which as States. as date, roxadustat, across appreciate quarter I the mentioned, today, Very to Thank forward are the looking we again, number the roxadustat progress of PDUFA very very date, everyone's I pleased United with in of report fronts.

Operator

concludes you good a participation. Thank your And for And disconnect. everyone Have now today's this you conference call. day. may

FibroGen (FGEN) 8 Nov 202020 Q3 Earnings call transcript