FGEN - Earnings call transcript Q2 2020

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Operator

Good afternoon, ladies and gentlemen, and welcome to the FibroGen Second Quarter 2020 Financial Results. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to hand the conference over to your host Michael Tung. Please go ahead.

Michael Tung

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

and may results statements are potential strategies trials; and Astellas; and call about but development from Enrique Commercial to, our collaborations enrollment, statements results Joining and Kouchakji, initiation, Dr. results I that me Yu, Senior includes Officer; of Chief call uncertainties our matters. business Vice Vice Senior to President regulatory Executive Conterno, from and Pat. our our our prepared our The call the that results; Pat Such on to and business; for is commercial today's risks today's Chris China actual call related for Thane to are materially in of other FibroGen. Chief activities; Medical design, with forward-looking include, Development, we cause our forward-looking conduct President results Wettig, could clinical to financial Chung, Dr. of Financial Elias differ Officer; Safety Chief of risks AstraZeneca Enrique Officer; which, today's you format Pharmacovigilance. certain Drug the statement research Chief limited remarks and that not regulatory made Officer; those Peony subject and projected Each operations; events will include would and our Cotroneo, our statement. After our up and on remarks and guidance; remind Clinical open like Q&A. Operations;

whether filings recent turn Investors FibroGen obligation financial a not call reporting XX-K result new section CEO. The be can found otherwise. including or future material most release today's and Form be the conference statements, Enrique update publicly on that of any press of as description complete to with website these Conterno, And Form a I For other call and at undertake can webcast update www.fibrogen.com. forward-looking a business like of its over risks found results with SEC, our FibroGen's our the of to information, any and the to FibroGen's events XX-Q. does and in more Enrique? would

Enrique Conterno

Mike. commitment welcome quarter earnings to life-threatening and patients like patients, call. conditions. and medicines to to by Good care behalf stakeholders I'd afternoon, presented you, FibroGen, to the health potential COVID-XX our Thank challenges everyone, second chronic pandemic, bring first-in-class and our XXXX providers, our continued Despite from the of investigators of on suffering reassure

monitor our goal a will providing new and begin will most from important high-level we Cotroneo, summary a stakeholders. the other format will accomplishments a are this CFO, for to regulatory to Ben invaluable second and I families. point clinical are know and employees history. of to Dr. then more expertise closely. and to I with situation the implementing community communications investment by the hope U.S. will this time Pat quarter. with China in please call, our care provide who Brennan, Cravatt of our want up the moment call improving interact to open Ben's will include others Aoife developments today's earnings Directors review diseases Today's results, and experience review Board. Fibrogen's Aoife's dialogue. and exciting your in development FibroGen, trials. at welcome With will and a in our take we which, After updates new our our result and Board us both chemistry biology the To We our clinical and our a to health Dr. in perspective with to world-class patients constructive have you and format providers, thoughts continue questions. and financials. We to regulators the countless your rare the

sales increase us get from environment an pleased the China million of in quarter. This China the with report $X strong started we the first China, normal represents in reported net net second million new to roxadustat are let sales to business With a return So of results. a $XX.X our for quarter.

by pleased leaders hospitals of listings at are driven the XX% as generally and is continued anemia efforts. of encouraged be especially the hospitals most were in a CKD roxadustat the China. listings listed key the practice. are IIIA the focus our Hospital opinion This early quarter, of ones adoption. Notably, the the We which expansion an second over end the quarter. trajectory of representing key the end in both over launch, in market to was by as XX% hospital launch being to first Class opportunity and penetration larger and adopters top-tier comparison the is of of with We're at which reported institutions, the continue

broad across and these see roxadustat and long-term countries. hemodialysis, well launch U.S. for populations to across to including other populations. provides the in learnings utilization non-dialysis Utilization important continue success patient different as We populations, prepare peritoneal dialysis and in roxadustat different we bodes patient the

updated China with aligns AstraZeneca the economic result treating maximize FibroGen. and new care our roxadustat CKD Finally, for the roxadustat to in in to more advanced and goal value will franchise predictable China's of amended The our forward economics making we patients. anemia FibroGen look long-term we you and AstraZeneca. as We of both of improved and standard profitability collaboration recently the optimally agreement keeping more

December NDA the the review for to mid-cycle now roxadustat. an and decision had in review by of this continue has We the with regulatory an with at we turn June Overall, commercial our U.S. expect the preparation FDA and to the the cadence of advisory planned XXXX. with on us roxadustat engagement Let time. not FDA an is are PDUFA committee that meeting pleased indicated FDA. The FDA date XX,

label FDA planned, PDUFA on of longer will are we the the with interaction commenting the given future no interactions be While proximity until those date. discussions,

to position brings than and efforts. years XX created we ruxadustat to On worldwide ensure Thane of welcome biopharmaceutical leadership is global many this newly of reach anemia we and appointed Chief basis. a Officer, experience, lead as leadership commercialization will with front, as the he Commercial the AstraZeneca more Thane will area. commercial on and where his closely patients Wettig FibroGen's Astellas, our working possible in CKD partners, Thane

with U.S. to work activities. launch closely continue AstraZeneca preparation regarding We

Within science. October, few abstracts the present Society the the Congress next American and have months, manuscripts a III At individual both covering to Phase meaningful expect trial sets. we to number up Nephrology upcoming and HIF-PHI on to XX of in we expect roxadustat data, of pooled data submitted

on Add-on with Drug We CMS Payment TDAPA. engage continue the Transitional to Adjustment, or

activities roxadustat defect one from of an to in U.S. the adult iron Agency European May. and primary CKD accepted Europe, of awareness imperative anemia Finally, treatment oxygen the sensing underway Medicines reframing the anemia of by the are EPO disease for chronic for was in the patients to with kidney filing In in deficiency disease deficit

partner, Our expects a decision Astellas, mid-XXXX. European approval

now hospitalized pipeline, of of initiated COVID-XX COVID-XX patients of we II objective separate forms COVID-XX. a distress of the Moving two clinical with in post-acute have The The could administration severe In was study trials from we pneumonia II/III safety suffering investigating with this on protect and a patients severe bilateral assess and trial pamrevlumab multicenter on and reduction approximately in will the newly majority blood to pamrevlumab, the approximately acute infection. patients pamrevlumab hospitalized causing COVID-XX syndrome. our patients starting in to U.S., started. ventilatory acute anti-CTGF infection June, patient in and This XX effect efficacy enroll the as patients from Phase the with patients hospitalized assess the primary of and immediate time efficacy safety the investigator-initiated studying study infection trial with will lung The In our trials. oxygenation COVID-XX to antibody, In of and pamrevlumab of settings. with initiated respiratory presented initiated the investigating in in coronavirus of pamrevlumab failure. is support. XXX interstitial respiratory oxygenation Phase consequences with Italy, acute

conduct continues temporarily enrollment this our lung ZEPHYRUS clinical of effective The challenges for clinical trial the the to moving function. of severely to months update vulnerability which two we across pandemic trials trial Now patient an with of COVID-XX due compromised present pamrevlumab's industry. be to ongoing to in of our to continues paused the IPF trials, our most

advanced reopened ZEPHYRUS have We resectable pancreatic anemia rates. of locally myelodysplastic our and enrollment cancer, continue syndrome for and chemotherapy-induced in studies and at the remainders slower albeit enrollment,

review the the and expect to clinical Pat end. LELANTOS, call dystrophy II our patients Pat? accelerating trials completed remain We of publish to DMD enrollment initiate updated to pamrevlumab a III year plan with focused over now I CFO, of we Duchenne recently trial while We of in two-year our from to non-ambulatory Cotroneo, quarter, data this will Phase all turn ongoing ensuring before a patient muscular safety. financials. Phase on

Pat Cotroneo

Thank you, Enrique.

XXXX quarter revenue of As announced as Japan. for second in current in roxadustat XXXX. today, of The net revenue compared of to quarter was $XX API sales of sales the million and China, second $XXX.X revenues million million total product quarter development for $XX.X consists million $XX.X revenue for of in the million $X.X

restricted million, million of for noncash was million second year. For year. cash, stock-based aggregate diluted was in million million share expense an loss a the deposits, costs income June aggregate the was Included and to share noncash as period million cash prior operating portion totaling compensation or expenses $XXX $X.XX million costs $XXX had last same were investments of $XXX XX, same net of $XX.X net stock-based which expenses and and per expenses which expense June for a per compensation or At and compared was in per result the to $XX.X quarter $XX.X FibroGen million, of of of ended XX,XXXX, million receivables. equivalents, as compared in a diluted and $X.XX an operating costs portion $XX.X of the $X.XX result and basic the and period, and for quarter $XX.X time operating basic $XX.X

equivalents, for received During milestone Both on XXXX, million assuming a connection prior of time receivables probable. in investments NDA and QX relating when and latest the million payments from of cash the U.S. these became payment filing. Astellas MAA with restricted to the AstraZeneca range EU payments of estimate FDA’s U.S. ending deposits, these in million, to as and second XXXX we million our the of to continue the balance to $XXX be cash, milestone acceptance NDA data, were revenue in milestone our filing approval year we from achievement $XXX our quarter XXXX. Based in recognized of $XXX $XX milestones forecast of

of milestones and approvals this first U.S. any would EU Looking next commercial ahead, the next anticipated months in we XX expectations in Thank now million you. and in to milestones point total like over $XXX anticipated U.S. over months. expected the the to And the Enrique. anticipated time, sale have At of over a changes back I in we no the have in our XX turn for call

Enrique Conterno

Thank you, And good. is summary, Very positioned. Pat. in well FibroGen

Our the capabilities business have And plans impact in achieve from resulting and and to uncertain through stated resources our operations effect. we these goals. continuity times we’re are seeing our navigate COVID-XX, while some to

As with at up cash from in is of CKD our FibroGen. in in of position to Astellas quarter. milestone anemia million second with million roxadustat financial $XXX China, of for payments adult sales strong the treatment EMA’s patients roxadustat the the acceptance ramp filing of end triggered The approximately $XXX

these shared months. expected of well $XXX for have million the we over in for approval estimated to geographies, milestones In developments expenses reiterating in total our roxadustat are ending commercialization received years $XXX where anticipated full on come. We in addition, AstraZeneca. million range partner to forecasts, and $XXX current million, XX reimbursement and all sale of Based our we’re all XXXX XX-XX cash of with a to China, be first we except financed and the next we commercial

Ashley, could the open lines now for if questions. you

Operator

Instructions] [Operator Leerink. from comes first question Porges Your with SVB Geoffrey

Your now line open. is

Geoffrey Porges

congratulations very little about have the bit you on ask Thank And positive much. to a that. regulatory I interaction.

bit warning secondly, get flexibility give give a the us much. more integration then of has to with color could And to how AstraZeneca unit? the or ownership a how important you Appreciate CV box respect is and particularly Thanks you agreement your how you So a And risk. that for little opportunity changed? black perhaps, the could business the commercial have whether of influenced question. us it sense with very China not may Enrique,

Enrique Conterno

questions. Very good, Geoff. Thank your for you

value both answer to the of to updated roxadustat. of second believe organizations try me the related think part Let with maximize economic to AstraZeneca. – best in the first question update China our agreement Clearly, I your agreement that your aligns we this

Importantly, FibroGen. improved also both this more agreement allows us to predictable for have but economics

been that a given of agreement see in to update product significant So a this very roxadustat becoming we that and able China. with having we chance opportunity the are blockbuster about excited good has

other were you referring think I how future this impacts plans.

– having this a think think in to mentioned the foundation past, us business it’s to anything, because in agreement think, think have flexibility we’re great not comment do roxadustat. I gives our anything if that. we more But on I for as prepared I I I

Clearly, to relates we’re roxadustat, mentioned, entire it make I be given totality be you mentioned it does potential including regardless. in benefit and look clearly, need that boxed I’ve – the and will says can planning As a at provide. the we it as think ability I past, comes roxadustat to others label in forward. we to labor when successful to it’s warning, to to going comments fully view labeling successful going not to that But label. very commercialize our at the look all when for the roxadustat, warning, boxed what a And this we the

to the product. We shows data that profile benefit positive view risk a our for very continue

Geoffrey Porges

you. thank Great,

Operator

comes from Michael Jefferies. next question with Your Yee

is line Your open.

Michael Yee

good know on FDA Congrats for the on progress. for questions me. can’t specifically Two afternoon, questions. comment the and Enrique, I discussions. Hi there, thanks you

The key question question the review guess of key takeaways review? comment. particularly a China. United as of Is cetera, about Second surprising the on second end just that. steps a sort the make is the can could the number you what a et different course. could or of my for gating on the I Maybe Obviously, from read-through quarter. the there you say, model, Maybe make States, I mid-cycle is a your So to meeting? has little that year a Chris cetera? pretty States a light shall could strong comment in to you you what be et shed on get more And are anything reimbursement United more are

So much much. so we maybe things. can you Thanks how could to talk into read-through

Enrique Conterno

that as the there’s to Very think, an we’ve you that it the review shared, FDA Basically the mid-cycle us Clearly, other planned good. it submission. overall on when interaction with asking FDA indicated update no are going of of comes Thank news, you, But mid-cycle Michael. I outcome stage. this to about forward. at is types is is our review, – clearly, the

so critical, I need FDA think but and will interaction no our And labeling it surprise, with clearly, starting and should those was But soon. discussions course, be are be of forth. engagement we positive. the preapproval inspections and our

we about So we good making. feel the that are progress

relates more a it to our strong on and to allow give Chris going I’m to little there. color China, detail us As results

Chris Chung

spectacular listings to channel it. second it’s about very so Hello, with a obviously, hospital That results we’re very nothing consistent things: with It’s adoption. from and market jump market. big believe There’s quarter. Thank at Michael, pleased the primarily of QX. is due you, our the sales. the looked in Enrique. We two increases We

through attractive terms the delivers the just the strength drug to and benefits think And, particular, it populations, is multiple a the of patient peritoneal and that convenience of tells ESA. the future and very of oral to reading you So feature efficacy U.S., significant China profile. over as roxadustat in in I non-dialysis, in dialysis a

Enrique Conterno

I Yes, think…

Michael Yee

in was the adoption I of sort non-dialysis? you the the real of word good be to clear, too. do So see guess that question,

Chris Chung

pleased very very adoption adoption the encouraged us way. launch that non-dialysis non-dialysis. in the had in been market a have the positive would dialysis, be We in anticipated We by but has

Enrique Conterno

Yes.

us optimism. a I of bit think you’re I sensing clearly, quite think, is from what Michael,

have but progress we’re now to we the during think you it that results the I good sales show making. last earnings sensed some call, probably

other with adoption pleased the what read-through a for in different very professionals of different patient are reimbursement benefits about countries? different but to roxadustat. lot And are We roxadustat the U.S., to care comes including the schemes Of have, – health seeing implications of countries in with populations. and the we adoption, see course, are think spoke you I it when terms the of physician this

Michael Yee

much. so you Thank Perfect.

Operator

Samimy with comes Annabel question Stifel. next from Your

open. Your is line now

Unidentified Analyst

thanks my Hi, on is for questions. Edwin This Annabel. for taking

added maybe treated China. NDD how the may. first split in DD new if launch I about them up? quarters? the could project the a you And you are learned second First XX,XXX question patients And follow-up, in if of or We that Mike’s with many What patients them on quarter? follow I to are How roxa. is in patient, there curve many the do coming then have half,

Enrique Conterno

Yes. Chris question answer to ask that I’m going in China. to

maybe, some roxadustat provide this don’t we forecast But Chris, around to when at it provide China. color forward-looking you know, you time. As can additional comes

Chris Chung

duration has end The has Edwin. and be Hello, XX,XXX these point being using terms of listed about segments, sales first in XXXX, and just and we just hemodialysis currently third, QX. Obviously, time, at patients, a pricing, is are this in the XX,XXX now. It’s with which quarter compliance half increase will there this third, the the of obviously DOT. the strong of At is the been are is estimate non-dialysis. getting the assumptions on into second hospitals in dialysis number from an a point reimbursement very treatment dialysis in looking two-thirds of peritoneal from other patients of end and time, Absolutely. based of because nice implemented many changes At roxadustat the about to believe by been which XX,XXX very trajectory.

project, us upward it we seeing will the very we’re in be continue at China. this be point in optimistic So to trajectory about for time, but difficult very to

Unidentified Analyst

think you do When on with CMS this negotiation, the got progress CMS, the two Great. point? or And at color. you Adcom regulatory significantly Thanks. preliminary issue? bundling after any for have is the Thanks we chance roxa CMS expect on any reduced clarity on agreement Do before with the possible secondly, questions. for And approval?

Enrique Conterno

good. Very

on the provide to question Adcom. try reinforcement related me a to Let the maybe

but So It Adcom think doesn’t mean with that is not them likelihood an clearly, the mid-cycle the for be we significantly. the the that FDA stage decreased at Adcom the called or this time, planning having is could it one that of had based not with no indication I the review. an it’s planned at on of at this Adcom has FDA is engagement – –

will but as discussions, maybe Once make we CMS as we can all hopeful appointed going our are basically that that and are discussions, quickly agreement done CMS some to clearly, the for Thane? then we as Chief expedited to there’s newly to are submit. I’m have can And our to TDAPA. will comments. other we – approval as we’ve submit we and get Thane ready additional done maybe such thing have approval. process to CMS approval, as And those of we homework ask Commercial terms chief an – that will In get Officer, we a on that – Wettig, that ensure than possible. no the get FDA the we we inclusion soon have be to

Thane Wettig

Yes. Thanks, Enrique.

to we then approval, HCPCS starts for date approval. and will think a is that TDAPA for And add most get once I and AstraZeneca the just important code, FibroGen said, Enrique process. the what review to us file

make And their within in Now XX beneficiaries goal that their TDAPA the with days. is within – available within product available can. TDAPA as to quarter possibly they CMS’ or to the they regs XX goal as quickly state is to make their

in of that’s power so doing our for that possible and assured earliest the have. availability rest expectation we AstraZeneca assure are roxadustat. that to everything TDAPA And And the we

Unidentified Analyst

a Great. lot. Thanks

Operator

from comes with question Citi. Joel next Your Beatty

open. is line Your

Joel Beatty

the last I you dialysis in need and Hi. window, gate-limiting of guess, the start place, TDAPA take or the order there to that Thanks kind product provide can for selling XX-day that questions. to taking up the on dialysis of help centers context to following as in such some are factor question the negotiations centers other with things there? to launching

Enrique Conterno

TDAPA, discussion question. – to You with right? I’m comment, to really great really both, I’m going Thane really you organizations. need going to the and need the need you dialysis have but have Yes.

Thane Wettig

right. estimate population, the treated And the are will two-thirds through – ESRD currently about Payment exactly addition, Prospective that System. in That’s patient dialysis-dependent those Yes. being for our is of patients

third Medicare And of so also there’s as through Advantage patients that go as commercial. the about well

we’ll only also those but not but now now actively and be is the just the conversations the so for not priority launched, designation through when sector available, And private TDAPA Between working having well. the and as product of availability even with stage through between to payers. set roxadustat

Joel Beatty

agreements launch? be something then as has to be with market? important may the type one Vifor you your maybe an that well? that. one agreement follow-up that that is Great. How just the that to such that dialysis are impediment would Akebia exploring And as Is to the of Or

Enrique Conterno

to We type not No. to of have or honestly, a organizations. limitation have we dialysis the do we able restriction of that view any be any us – for with agreement

point a we feel So time, we’re in position. at in very this good

Joel Beatty

Thank you.

Operator

Your comes Gerberry of Jason next Bank from question America. with

Gerberry Jason is line of Bank open. America. Yes. Your with

Your is open. now line

Jason Gerberry

view a for you impediment to that Akebia Sorry, other is Thanks to is, company then XQ. a contractual Enrique, you seeing benefit my my like progression garner it for hospital XQ the little bit on Thanks. last saw What see the curious how your organization question the Just And progressing on follow-up you’re ability going guys. value mute. kind that if the how don’t the just a do about the an questions as I in China you listing dialysis arrangement comment. uptake was to in of talk think with having versus of in market? you can half? we second from taking

Enrique Conterno

Yes.

question. your for – I think on thank you

really over question agreement. one to comes first this the hospital is question probably not that I’m sure XX%. XX% for think pursued mentioned, we given as they’re that listings, it a a basically It’s When FibroGen. I Akebia, from to over the went question – on is for we

at XX% were the of end QX. we at So over

were and penetration the of the at that at QX. to XX% over I products benchmark products it very post achievement, innovative and overall in China, opportunity will level some is of now China, think to end comes blockbuster are in we the of of that blockbuster launch. I XX% the be basically second see opportunity, significant you think, milestone to when this at in quarter China If We

extremely So we good. feel

continue We future we but listing make forecast provide revenue stage. progress, to or this to it do not expect to comes formal quarters at for whether either

Jason Gerberry

Okay, great. Thank you.

Operator

next from with question comes Your Yang Difei Securities. Mizuho

open. Your is line now

Difei Yang

taking Hi, my good thanks afternoon. And question. for

Just a couple.

first days, you patients roxa of The the population? most in do for adoptions on in China. patient going do the ESA but you one I know see prescriptions early board to dialysis or that it’s in the population, failure across see

Enrique Conterno

call some color once give additional on us? to Are tell Chris can me Let these you dialysis-dependent or naive they us what failures patients. some treatment ESA of or again on

Chris Chung

So those all you color hemodialysis a seeing segments. population. we look to across To at the patient little adoption give are of first bit

patients inflamed iron-deficient getting and hemodialysis. in are We hyporesponses

on the On who past. very of patients, patients a ESAs for conversion dialysis, of well properly how to and we performed as of lot oral however, in ESAs. are the conversion patients ESA-treated seen are they have administration, responded regardless seeing a well maintained not have peritoneal have large We as new because

that peritoneal So a hemodialysis as non-dialysis very, differentiating I value the of in the and the is profile, of terms think in to it's same dialysis, and strong well. case product proposition very

Enrique Conterno

patient peritoneal comment dialysis large Chris, about that. maybe has also about Maybe uniquely population. can you a you can comment China

Chris Chung

Absolutely.

years. XX% XX%. percentage couple in but peritoneal in has The government of around around is is increase patients, China X right it, the expected dialysis So trying to been dialysis next exceed the population it's XXX,XXX to now, currently million of stable at percentage. to that terms

there course, XXX,XXX rate So PD adoption just dialysis the population take in if the seen than very, actually and new trend, China. Interestingly, And of because going Unexpected patients, in roxadustat peritoneal in not very base many is has strong but patients week. higher into both times you patients. very, over We've a patients a played it, hemodialysis very initiation currently XXX,XXX XX% are China. new in center positive of installed COVID hemodialysis. to for be factor prefer of three to adoption a

Enrique Conterno

Thank you, Chris.

Operator

Cowen. comes Your Werber with Yaron from next question

line Your is now open.

Brendan Smith

guys. very Yaron. for This Thanks taking question. much Congrats on the on is for Brendan progress. Hi the

us. couple a quick ones Just of from

about the kind First, thinking learnings launch so really the of in the launch, and ask wanted to challenges, also on trials. wanted all you're ask and U.S. up then and light important quickly of picked these some from I kind bearing mind. how the I applying just MDS just what's of about And level going you've some of particularly top far of to most of here about key the just kind in China CIA to you're considerations

from If you very we and data of enrollment, get at where more might either you're lines us can in those? any granularity some give on respective time when Thanks much.

Enrique Conterno

Yes.

it have I China, to it's I it's best our the able think given in grow different in markets. Let the ability can interest other MDS and probably we the patient discussing your not me in from learnings CIA as imagine, think the one roxadustat try be that we've discuss Peony When ask is to to trials. comes to those, of address things first question. I'm that both to going competitive environment be fair say, But to have to that we to learned that you populations.

I into because hemodialysis, growth given broad about future. of that number to is non-dialysis we dialysis, spectrum give a legs patients you just different us And for it's think a huge when can peritoneal the of think important grow. it ways gives this patients,

Peony terms both an us do to going the in this longer-term to that for MDS it what ask for CIA. could about also on and yes, but now I'm what U.S. product of short-term, update excited very could us to when comes become. think, So to in launch, give And us the

Peony Yu

we not And the anticipate going strong are adaptations investigators instituted monitoring the the seeing executed increase that of inevitably review same with successfully. time, have and be to At to has well. during patient all because but to – two Thank trial some study visits pandemic optimizing our our continued able sites. some remote to And you. while the integrity. the remote on were studies The MDS in and able the these and are managing patient COVID effort will so with that CIA or enrollment. data we had of some study we Both these process ensuring we be ensure data investigators subject well. impact work are And – continue in safety

Enrique Conterno

We enroll ensure feel to enrollment impact, has can think Despite trials. that very team adapted about of with good those we the both I well. our appropriately the

Brendan Smith

Okay. Great. Thanks very much.

Operator

with from Your Goldman Choi next question comes Sachs. Paul

open. is line Your

Paul Choi

afternoon, priority you taking you. U.S.? at the Thank see I the about you CV adds partner was could totality how endpoints MACE And of updated comment could that Is to our And few and NDD are just in the me, presented you with the MACE+ the wondering thanks your here then in how comment data? if you. roxa your the you data thinking questions. to and regard also thoughts dialysis existing and maybe for home please. DOLOMITES potentially given about from and on role far, either separate a in potentially a on do think unlocking shareholder a it had marketing monetizing Enrique, so study or setting you've of Thank that the about that Second, Good from A potentially uptick the commercial China everyone updated as it entity? maybe Hi. for you value Enrique, business to thinking meeting. market? how that recent you? medical from there third, how

Enrique Conterno

Very good.

the few around in try – I'll opportunities. China different answer Thane? I'll then maybe comment; and DOLOMITES, ask roxadustat home shareholder comments; to ask to people provide your answer and on the dialysis, Maybe value. have to to Let Thane and I'm question unlocking going the Peony opportunity on a me

Thane Wettig

Sure.

I dynamic the not As home MDO dialysis, taking need But to dialysis now it it's take it's a the of look China. are clearly LDO different level of the relates advantage to what in as priority at segment the the order think right population. other dialysis We're with than thing to centers. it or centers it we Same in NDD presence that. determine the is or a hospital-based

Enrique Conterno

Yes.

of size on relative and product profile, very clearly the than DOLOMITES? the NDD favorable smaller opportunity have is here in We a China. but Peony

Peony Yu

Yes.

study MACE is we In of we DOLOMITES, efficacy And darbepoetin of in that to believe ratio MDD confidence active hazard further comparison the compared against comparator. demonstrate this roxadustat. on importantly, on being provides X.X. the roxadustat control active So that,

building on the analysis. this is top incremental so pool non-dialysis of confidence And

Enrique Conterno

say comes can your on in to we can. that. Paul, you it the be shared we've to to we and mind, for is course, the as pivotal part was on as see the as U.S., not they the there the I I FDA are pooled is value studies what think before, Keep can the studies agreement are results analysis way in to possible the value But in of make that much as large question MACE DOLOMITES with us possible are, encouraging. of that When roxadustat in China, China unlocking best lock think we as ensure as for

I'm when going revenue So look having that we uptake China, I launch comparing at look their we blockbusters at a at think in either this listing – benchmarks when critical. we again, well. when Keep for roxadustat and uptake, mind are to or in look studies innovative products mention extremely us, is great of think that I

So is clearly, think one. priority I this

huge we given that have to I've that the are we China appreciated believe for mentioned, looking opportunities business going I there. is that we us at by value all think our ensure to our fully be As shareholders,

Operator

have will over We of Q&A Enrique session. for the I call remarks. closing reached end now turn Conterno the to the

Enrique Conterno

earnings on want I joining team everyone the us the are to they to type investigators, But once Very commitment FibroGen us to particular, regulators in thank of seeing progress for agenda. our or entire again, care good. professionals, that And health I for patients the whether progress our we allowing collaborators, want of to call. are all that today. thank are this

So thank much, you everyone. very

Operator

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

You now disconnect. may

FibroGen (FGEN) 7 Aug 202020 Q2 Earnings call transcript