FGEN - Earnings call transcript Q1 2021

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Operator

Good day and welcome. Thank you for standing by. Welcome to the FibroGen first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Instructions]. [Operator that being advised conference today's be recorded. is Please Instructions]. [Operator hand over to I would speaker conference to like Mr. now your the for today, Tung. Michael go ahead. Please

Michael Tung

FibroGen's and results. I Thank And Michael Tung, fiscal good and of am at first conference Corporate FibroGen. President to Strategy XXXX financial you our Relations call XXXX afternoon quarter Vice for Investor Erica welcome everyone.

actual committee statements. to FDA and those guidance, trials, other expectations. operations, and initiation, risks and are potential such and are plans strategy Development, Mark could Conterno, may to include, the business remind you financial statements to, our Scientific Joining related design, I events Elias forward-looking me differ Financial Eisner, risks, our anticipated current after advisory from Officer, of anticipated research commercialization limited call regarding enrollment, Chief that Officer, Dr. Pharmacovigilance. Thane Chief Safety Cotroneo, to Executive Chief meeting regulatory Enrique, Wettig, Officer, and on Such collaborations subject for call our and FDA would Vice forward-looking we today's Chung, uncertainty and like made prepared Commercial market FibroGen's and remarks clinical our regulatory Senior Dr. statements may from of our of to call Officer, based planned our our with strategies and The results Medical open results will and in cause Officer, matters. for Dr. include Percy remarks results, Astellas, Chief Vice statements China Operations business, which not of Clinical are Q&A. our conduct other our up AstraZeneca Drug opportunity today's materially activities, Chief on and Such today's President interactions that certain our Pat statements Enrique results President format but the our our call and Kouchakji, Carter, development significant Senior includes on Chris

call recent risks and result otherwise, a disclosure www.fibrogen.com. update press forward-looking business, our the I future business not quarter For please a And fiscal X-K financial future as most FibroGen required quarter a in turn may release CEO. any of XXXX discussion results be new business the Today's currently by that, Enrique? of based to Securities fiscal Commission. to press of found affect over whether and our reports All XXXX call publicly reporting FibroGen's first reporting on does of section events information, With our today's financial can results undertake could Investors and and XX-K that and to the first update website XX, statements information that as statements, any and May or XXXX and release obligation factors webcast except as at material financial our Enrique other like would to results conference and our we and to file update, today's Conterno, law. of XX-Q available these with forms those us. refer are made on today, on Exchange

Enrique Conterno

would ensuring executing strengthening and productivity a and summary of months. pulmonary Thank regulatory our success in Pat trial three I first and performance which financials Number call shareholders And Mike uniquely with external with pamrevlumab our anemia, that for Today, both in value by will for medicine provide but commercial patients reiterate Dystrophy your China our accelerating and Number the after position, on for patients would innovation. to three, our by of strong of significant pancreatic areas call. then additional and expansion two, like is of my kidney the positioned growth review we slide up And leveraging of accessing focus, number good open indications. tissue two. development clinical XXXX significant biology quarter three accomplishments the shown roxadustat, treatment welcome the create I as hypoxia-inducible in connective transformational significant disease, indications assessment Today's on questions. advanced high earnings a in recent by FibroGen you a programs. to leadership idiopathic will include to developments the review research chronic fibrosis. Duchenne Muscular of potential one, continuous our unmet and treatment in afternoon first and with level for to most call everyone. Cotroneo, [indiscernible] cancer, of CFO, important factor unresectable factor and medical roxadustat,

get Let roxadustat meeting March, or to drug NDA. NDA we hold has the In committee new with that announced review. application advisory us for roxadustat started FDA decided U.S. the an

In remains analyses we April, for focused FDA the advisory the disclosures safety Phase for III announcement preparing disease. for chronic prior Our from medical cardiovascular investment anemia primary scheduled on tentatively of and meeting, at for an team kidney program of made community the certain treatment which upcoming roxadustat committee the of XX. to clarifying July is the

meeting further Our and the with had we the FDA productive productive discussions them was outcome. with regarding have

with in overall to safety dependent impact dialysis-dependent in placebo comparability cardiovascular not roxadustat does non-dialysis regarding clarification epoetin-alfa to patients. of this our respect conclusions to and patients Importantly, the

committee but for the stratification the As to epoetin-alfa to pre-specified on regards that discussing safety. incident to cardiovascular look in comparable We is X with factors to April, publicly the July. dialysis safety of subgroup based not the the superior analyses forward at roxadustat described advisory on cardiovascular

and reached thus and productive appreciated. to journalists leaders, have and matter medical investigators the out far this discuss discussion We been primary have key opinion the

expeditiously and will to we progress appropriate at internal review continue our We time. communicate

future. to are confidence safety we in CKD roxadustat working this and together of with the want have AstraZeneca with Phase the Importantly, we efficacy to putting in to profile reiterate and roxadustat the in the U.S. III controls are that anemia bring I committed place to and prevent demonstrated type occurrence continue in the in data program. in FDA to patient the FibroGen to

National additional Meetings have ongoing Our disease Foundation, activities the roxadustat there FibroGen activities education to in Spring from professional expected and and launch. are official to through clinical pre-commercial of Kidney the the interest Congress the continued. recently Healthcare Clinical community. World at significant and Nephrology the continues be ISN analyses increase presented

but as with organizations Our payers In patient as comprehensive leading has to roxadustat to access, quickly renal who U.S., CKD a order the make as is cover non-dialysis presence partner, AstraZeneca, commercial possible. in ensure and with committed available we patients to dialysis AstraZeneca are many discussions the patients. together,

covering studies III to peer-reviewed the We have anemia Phase submitted journals. manuscripts CKD

slide the been of and both Phase encompassing and months. have six manuscripts in publications data three, in we non-dialysis-dependent additional these noted the III coming As expect of published data dialysis-dependent

Astellas XXXX and dialysis a ended approximately chronic the $XX mid-year the And Europe. European with for the million expect XXXX. recently this on year for of both Europe, which for by first and Agency we In kidney year anemia roxadustat fiscal application reported marketing year decision continue They quarter. includes in non-dialysis sales the in to authorization EVRENZO Medicines EVRENZO calendar in both patients disease. of the treatment fiscal guided sales guidance total their to Japan

now to China four. Moving on slide

fourth of hospital net to within continues XXXX. broad listings the hospitals. We an to partnership in to million roxadustat by roxadustat first in expansion and driven quarter both FibroGen adoption of structure, Under for revenue revised reported in the listed $XX.X the China product quarter million are XXXX. for $XX.X net China in uptick versus increase quarter sales of total be distributors in first $XX.X pleased report The the million

conducted selling As to previously overall continue expected FibroGen AZ's portion The responsible responsible China focus roxadustat pay for entity China. launch we was items. have disclosed, in quarter, by collectively end to JDE for distributors Hospital going will distribution of account is the will share. at and efforts. continued was at these key quarter, sales listings first represent of opportunity of roxadustat be CKD The profit be efforts listed AstraZeneca's forward. market first China commercialization hospitals for XX% rest our the beginning XX% a our FibroGen. the directly jointly-owned that for the of roxadustat of the in approximately over is to volume Notably, to or JDE Previously, and

slide is roxadustat market that inclusion As ESA has the on NRDL of on five, thing accelerated. you the interesting see growth the can

over prior year. revenue the six period months ESA the fact, last shown In has of same the XX% over growth

great uptick six. which to roxadustat the it growing into in Moving Roxadustat slide on anemia over new adding the anemia as an roxadustat shown the with ESA the market, CKD has slide, growing CKD the that along is which share months, this is a roxadustat category expanded evident of previous is expanded past view sign. to translates category. Combining category patients XX

a for all products treatment of on anemia past for CKD slide XX% in the roxadustat seven, months segment as HIF-PHI market. two ESA the roxadustat, number shown the only value in includes is that branded one with on the share the currently China each of on Finally,

care, We anemia of continue pattern peritoneal of the treated advance launch broad term look long as of success CKD and This roxadustat in China's including you term the in on with prepare dialysis a roxadustat range learnings anemia patient making covering U.S,, forward XX% are Approximately, dialysis, as bodes critical well see China standard of significant keeping population. of remaining hemodialysis Europe and in dialysis. for to roxadustat we utilization CKD for patients the We utilization of other provides we roxadustat across long countries. not the and to while XX% patients. on goal are updated our

our to with starting now clinical roxadustat. Moving developments and

or now U.S. we in extension Phase patients two quarter, conducted transitioned completed During anemia ASPEN organizations, into patients CIA many dialysis IIIb and the of In our our anemia with II the Phase have CKD phase. trial. chemotherapy-induced enrollment DENALI, studies roxadustat

present expect topline medical future We to at meeting. a data

pamrevlumab. of life-threatening to the treatment Phase for in DMD track designation patients. patients Pat? over DMD. double-blind, was option financial of pamrevlumab will CFO, with this serious now for to potential disease from of of manifestations Pamrevlumab Pat In provide for announced recently fast the as updates. and we pamrevlumab the Muscular the granted of ambulatory turn LELANTOS-X, and to of rare our now disease and rare the We I March, placebo-controlled pediatric value our a the III this Cotroneo, FDA call support our mission treatment Dystrophy. designation initiation trial Duchenne U.S. Moving randomized, acknowledgment

Pat Cotroneo

Thank you Enrique.

the consists as first for net active million ingredient. revenue in in the for or for of drug today, XXXX. The of in million drug to XXXX roxadustat development current quarter $XX.X $XX.X $XX.X total and bulk China, was quarter compared roxadustat for of quarter first product $X.X $XX.X revenue in revenue revenue announced product pharmaceutical million million million sales As revenue

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

commercialization As quarter, China is mentioned items. and the the roxadustat and FibroGen share. portion Starting have to financial jointly-owned FibroGen responsible of was AstraZeneca distributors call, profit pays some reporting. AZ's in made and for entity in efforts this or JDE between distribution for responsible these selling AZ's last changes our Previously, in for the we

roxadustat the As JDE directly while accounted over continues conducted be rest China for of March to of overall the by XX% FibroGen. XX, volume, sales

to provide To business our JDE sales product of total GAAP FibroGen's first under China, roxadustat this in million new roxadustat revenue was roxadustat XXXX. our million for China. as generated included through sales sales, such, from of our U.S. basis, quarter revenue operating the well our XXXX sales through its the direct JDE net $XX.X context China distributors, a As FibroGen and as to distributors of reported quarter in for in direct including FibroGen $XX.X the which structure, on net for sales the results China's first

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

Enrique Conterno

regulatory In closing, time geographies. Europe very in in China the perform this Roxadustat is to an U.S., review is and FibroGen. under for exciting continues well other and

three forum. is the look Committee Meeting medicine need, idiopathic pulmonary and forward Our Muscular significant potential, for is Advisory tentatively fibrosis. first-in-class data presenting a pancreatic indications in advanced Pamrevlumab for and roxadustat public team wholly-owned, we locally remains with cancer, to unresectable focused development in Duchenne the that Phase scheduled medical XX on III July upcoming unmet preparing in Dystrophy a new

to research continue we advance our agenda. Finally,

our delivering of scientific looking are opportunities of a for unique We external while expanding innovative goal pipeline with and expertise candidates. capabilities, our drug our broadening also internal on strengthening in

will position I slide are on Chief culture in during recently She moment responsible $XXX people would reporting cash welcome and shown milestone a approximately XXXX. Genentech expected with and to a FibroGen $XXX strategy. of our Stewart, take Officer in appointed we in also roxadustat advancing like most for sales ramp-up, me. who roxadustat at recently strong Tricia from we million and payments as financial million comes to As and People anticipated eight, another be

for believe Looking positioned are forward, we I success.

Now, I operator turn would the to call like to the back questions. for Erica?

Operator

[Operator Instructions].

from of the question first Samimy. line comes Annabel Our

is open. line Your

Annabel Samimy

RBC could Maybe transfusion, the Hi. my have analyses feel was question. benefits reduced the those mentioned accurate? some comfortable meetings AdCom, but the taking you iron or presented clinical are you in Thanks if during can better those critical comments that preparation tell published of were you And then data the regarding wondering at if secondly, not conducted responders if learnings like initial or claimed, us am missed you Thank what the I additional for can of inflammatory learnings presented with you. status China. And I utilization? any that you for for sure or are the us? an had that highlight I

Enrique Conterno

Very good.

about roxadustat benefit Medical Let me Officer, to CMO, turn Chief risk your Mark profile first question and Eisner. our

Mark Eisner

Yes. the Thanks question. for

in So in roxadustat yes, reduction are have functionally who CRP patients answer the iron yes, hemoglobin high terms and is roxadustat, in to your having we of with questions cell transfusions, confirmed the deficient. red benefit additional benefits with increase

to X have April press we has not results those release. changed been that So all able since our and confirm

Enrique Conterno

us CKD are impressive the in good. I Clearly, of gives lot continuum both in a anemia comes call, Very treating how when think that a roxadustat China. number it China, confidence capturing to comes I China results will to the short patients of better are and learnings think China, NDD. nothing of There DD of it quite I it a we when for is frankly, becoming from choice across and

of a One launch, of also always impressive. was, patients in I feedback because roxadustat first a think when discussed the clearly of think have comes risk in could overall real now in roxadustat healthcare professionals what them, also quarter-on-quarter continued of terms what basically I And faster benefit where that string NDD have not seen we have that few expected we world. we basically the it segment. growth but the from is basically uptick excellent we and offering just quarters reflects past in to I the mentioned have particularly quarters be seen than we feedback in the a the But profile seen

very think the I we markets. So of potential to that are it's very, other that and with honestly, encouraged readthrough

Annabel Samimy

Thank you.

Operator

comes Your next question of line Michael from the Yee.

line open. Your is

Michael Yee

questions. update. the had thanks We Hi. and Good for two afternoon

terms about I things in that be to like expectation can the from shed ongoing second of And Or how Thank about think an was, first and will maybe sounded AdCom conversations that discussed was of which being light it The a good of Maybe to general or areas that that talk how since an of you. that things? you terms group. does could separate into you in related for be think would the interest have ongoing be was, had had standpoint? great you is the could on relevant you discussions? extent cardiovascular-renal panel, a reviewed know topics you that focus from the you with? group that Is some dialogue play have

Enrique Conterno

I Yes. after him. I both answer to will of have complement Eisner try to those And am questions. Mark going Mark? this

Mark Eisner

Yes.

for question. thanks the So

yes, AstraZeneca very I he agency advisory committee. been information give and sure So we and have the and at want they advisory dialogue program. committee discussion a committee with that about make the fullsome understand need the thin advisory FDA both cooperative FibroGen members the have we this fully having partner to our to the

the CKD In expert risk safety input, medicine explaining further particularly around getting for it the CKD and characterize I anemia. the to terms treat efficacy themes, profile benefit and the think and nephrologists and population roxadustat from of DD for anemia who NDD of the patients the just largely would of with patients with

conversations yes, and it's actually the is. includes renal with benign with but OCHEN both hematology level And cardio-renal, had division. the are cardio the cardio-renal of, So be kind terms that's advisory But answer. you that's in with committee, will a the mentioned broad of a where at this agency moment. and also we it we have that drug office which at the

at now areas. various levels So of the FDA, for stakeholders both we these including have those had with all discussions

Enrique Conterno

preparations progressing are think think, to when just the comes I maybe add outcome, well. I Yes. that it will our I

Michael Yee

because The that have that actually Is experts reason a just I fair you supposedly and be ask on or renal yes? not people on they positive, Because familiar nephrology that rather that? is would this with statement? experts would will a than panel think be who there are the

Mark Eisner

setting important nephrology the think experts, with FDA believe both setting. because it to have is do CKD I dialysis patients they which I NDD have anemia, in treat the to intends and

unique in positive. they where position benefit understand So of risk are to good and the very be going is the roxadustat to a attributes

important to to So yes, I think nephrology input. really it's that be have going

Michael Yee

Thank it. Got you.

Operator

Your next Edwin the Zhang. line question of comes from

open. is line Your

Edwin Zhang

question. Hi. Thanks for my taking

the and clinical I of are and design dialysis have First How ASPEN please help one, us study organizations? then follow-up. a of remind And new purpose you affect going adoption the the or the can the U.S. roxadustat in DENALI trials? to results

Mark Eisner

Sure.

that's and I patients. dialysis the real-world provide think studies that a large an single-arm, So clinical trials, DENALI conducted real-world It in a ASPEN a roxadustat understanding open-label But a is trial. organizations for they one are much that's very in clinical more is it setting of in setting setting. clinical conducted will hemodialysis

patient are of are we the year the I present roxadustat request use expecting can mean, the they organizations, end the We And to their data, scientific a the for that understand in so committed data the large dialysis their and all value them further available to by of meeting. to at populations. in sometime making

Edwin Zhang

DMD. And thinking opportunity of on what's Okay. data? study, expect the two-year Thanks. Are pamrevlumab we to going the on a publication your of current pamrevlumab in including the on DMD? market Phase last My II question

Enrique Conterno

Yes.

on publishing on and the Duchenne Muscular question Dystrophy on answer two-year pamrevlumab questions, data, data. We the particular, will around that in have Mark

Mark Eisner

All right.

outcomes to process the we in the of published. are two-year working So data get

a have don't for date you. specific I So

think benefits we the two. We important that one And year to actively. year are continue on between how working do show and that's

Enrique Conterno

DMD. The DMD frame of maybe the at or And you than we that them opportunity. I from to LAPC about is of clearly, pamrevlumab. and look opportunities the We each to is I a significant to its then those But one were IPF be LAPC when of other larger context it's have whether DMD, the and massive try then they two, think the in I it's that three each basically that one IPF overall opportunity, let needs. represent on in The clinical think three as significant important say do expected see own. opportunities, IPF, programs of we significant unmet are these collectively, And for opportunities. me opportunity opportunity asking think

the of not half year LAPC we in a results in readout share We to IPF, from we think, expect and that but we the near while the results future. case have second time, DMD a will next I perspective, of at the in that, expect specific have shared

Edwin Zhang

Thank you.

Operator

question line Gerberry. comes the from Jason next of Your

is open. Your line

Jason Gerberry

NDD. proof ending that might products guys. just Just ambiguity inherently just subsequent Thanks may about moving forward you with look thinking guess to kind benefits benefits? taking assume the what to product the the question questions. my of to of organizations of upper for launch? the as the that the burden Thanks. of wonder safety bit remind action of an morning dialysis a class matters? can AdCom. DD, those interval helpful a there suits? third financial second and can is and I sort just and then first on shareholder think just the from you would of Good your phase slew little the of dialysis NAPA approval, what these second the its on financial are about to implies some is come second the is what's of some third And one confidence hop I thoughts the offer some is they and market, my It of about the longevity HIFs But assuming framework these I the provide us around if on FDA suits, fact just bounds curious legal in shareholder

Enrique Conterno

you. Thank Yes.

your either litigation. think do potential we on question, not first I comment or on ongoing

I move or from and couple maybe about question other, HIF the whenever make. will that or contracting the as of far able to HIF, comes, it As impacts to how HIFs one a comments third second would the being dialysis your organizations

is First is, important. first launching clearly

basically showing therapeutic go-to-product, think that launches seen different tend second, yourself terms And then you many or of can to no the with. that's work end healthcare the who that studies and experience to experience there across professionals HIF mind well. classes, the how because one in as establish frankly going day, basically is product say in of at basically compare from different and the have to look also the the real quite have at we across to the clinical switches that Keep overall. have other We products that data I does

are as comp we it number there that So from of one be should classes, just in in same therapeutic and either variables. or for switch different And convenient be I to that other it's the a drug. don't products believe appropriate seen large will have thinking, we that one basically to

think to have there lot made. considerations be would are of that I

Jason Gerberry

Thanks. it. Got

Operator

comes of line next question Your Porges. the from Geoffrey

open. Your line is

Geoffrey Porges

you much then very taking hopefully wouldn't I first of the and one, can. that questions. you will that Thank for one couple My probably ask kind answer a you

think completely those thing. CIA and then about whether indications non-dialysis the studies second and next post-hoc basis in price the is, you the the to would Phase the to obviously in to of helpful. half all with FDA, different the and the bundle the and the is stratification be and rate that in labeling the MDS coming And year give then have points sort indications III are discussions of the going of where, you dialysis be or these have Phase II of a can And stratification? course, of first That secondly, for year. The you us sense beginning per-protocol discussions

forward? revenue thoughts, market, expect reported is going comes Enrique, likely under markets? arrangement that's you total the results just price is remain a into And much as feasible? the that band? of So is in actually bouncy? Thanks. have price whether Or the the to be for it revenue Or about any new relatively lastly we pretty And the really you to whether Or you China, then in percentage increase? different going proportion that whether same differentially had further should your will to to constant

Enrique Conterno

your questions. Thank Yes. Geoff, you, for

it we those the be Let me analyses think think the interaction our first comes primary the when it number state sensitivities are of including any our analyses. will Clearly, looking evidence, comes that providing a the I really I expect general, interactions. to not when we and at in that FDA, overall what says of also just with detail around FDA on to some

So in feel far that the discussions good discussions. our we are very FDA with productive about they

In and it terms going CIA the is also to clearly I also need forth it comes we the are basically CIA to of when MDS, so dose when biggest in around where but, your It's the question is. CIA seeing. that's course, of MDS, differential price to that to are and see comes on II based Phase results, is and what what think we

meaningful. difference anemia there between In slightly pretty price, roxadustat. example, different don't I as of MDS, the MDS So is the significant view I or and with wield markets the expect being be for products case price that CIA would might basically for them some points, while CKD there used a

the can, that pricing want always the in that U.S., I to that or different is challenge do And all on is that. particular. a the make we the value that think in it's fair goal, populations. challenge are we based is we that product sure know how while the It's that the that medicine effectively appropriately to in a so that we offering

the our thinking is point just has to commenting are are offering thinking different populations. of about part that clearly this the appropriately we patient ensure strategic But in at receiving how be what time, we that. to we are on roxadustat that So not value for

We sales number joint factors There that proportion this. XX% and the to indirect somewhere into be proportion the a number net to is during FibroGen are provided earnings between asked whether that you question that to last guidance, this about will and overall distribution revenue sales going some the Finally, be that FibroGen's I think, forward. going XX%. of ongoing play call we expected we that between entity reported the relative and reported quarter, the distributors that

that We continue type with of guidance.

on I a So to considerations. number of little based it's going different bit bounce think a

at when patients clear that performance think it is valued roxadustat of line we of think overall here net in pretty having I really I terms the the product it's in look think distributors, and incredible that I is bottom what China. sales is offering through is

Geoffrey Porges

very Thanks Enrique. much, Great.

Operator

from line next question Yaron comes Werber. the of The

Your line is open.

Brendan Smith

much for very questions, taking Thanks is the on guys. This for Brendan, Hi. Yaron.

Just us. of couple from quick a ones

maybe growth behind there? identify China, there it dynamics the specific more I sales of some first, the that And we at QX I maybe of of just just supposed this sales in you less Are could you then that can see year. drivers mentioned serves, ASPEN January some memory year of originally. the I the and secondly, to us at to DENALI were from just maybe data like we commercial of think, play February looking roxadustat think get kind are in looks help If by understand think there or that this that flattish. and on studies, end now data

that there in treatment very there be you much. able to or have enrollment guess, I comment might any Thanks So delays on? been

Enrique Conterno

Yes.

Okay.

case. in you China as to I And said think me you try address Let don't and in they China. I flattish sales January the think your February. were, if mentioned were I understood that's maybe correctly, question that about

For roxadustat, increased are right. clearly, growing market, we in increased are seeing share seeing we basically a and share

and QX in clearly have distributors, sales now we or of are. we net overall we very I with its when the XXXX. good sequentially sales north first feel we internal quarter, through our XX% about seen at look right increase, of reported And a significant the QX So XXXX where we just between of sales think that

to for question DENALI that's was answer and second to And I So your the related I going ASPEN you. have Eisner Mark don't am case. and believe

Mark Eisner

Yes.

two when, things. it's study, I different is use. label there own cuts think an for organizations dialysis mean, potentially data for provide that since their is the to One open I possible it's

a study talking meeting. that What consistent available, be as distinctive be we starting I So QX think data about that to medical topline expect end from factor by we was when overall was a should been of year have I that possible. was at the

Brendan Smith

very Thanks right. All guys. much,

Operator

the of from Difei line comes question Your Yang. next

is line Your open.

Difei Yang

afternoon Hi. thanks for Good and my taking question.

able questions. ASPEN mostly is Fresenius Just Circling be second of balance the would are And trials, it's if the sites, related to and the DENALI or two? to clarify question a sites the two clinical AdCom. or to DaVita the you back

for this it by the FibroGen? you. Thank role AdCom? for what's driven primarily Is AstraZeneca So

Enrique Conterno

Yes.

me, are DENALI AdCom, very FibroGen But not quickly are dialysis organizations. studies with. with we clearly the Let those the And course, we sponsor. who on the far large on doing said, this it's as we as as is are just and we doing ASPEN, of commenting

sponsor of the Mark, provide And NDA. on are AstraZeneca. we the the maybe, additional role some comments can of you So

Mark Eisner

Yes. describe I will collaborative AstraZeneca. between and highly it effort as a FibroGen

advisory to team essentially for the the the prepare have ready presentations a prepare Q&A. working for We formed committee, they to joint and are

process both collaborative a So it's highly companies. between

Difei Yang

Thank you.

Operator

from Your next question the comes Choi. line Paul of

Your line is open.

Unidentified Analyst

This on the quick Lisa, A from question. Thanks Hi. one us. is for taking Paul. for

how can you you. walk you Now has and timing pamrevlumab us that and DMD about regulatory through updating designation any potentially program, this its well? for in thinking program, are commercial fast as Thank track disease pediatric rare

Enrique Conterno

Clearly, comments be color. patients comes some that our can will complete add Yes. this and medicine additional bring and us to key of the some DMD the will when Mark Maybe is think our really I we it able I ensuring to enrollment for make to initial trial.

the have where in we as overall a diligently both To we we in as enrollment the global very have number closely, to started o patients our will China, to of for the and that program. working to contribute of are that try in DMD DMD additional quickly recruiting sites, as ensure including end, added happen approval we can well basically possible. now that trials gotten So

about designations. So excited we are those

Mark, relation any basically designations FDA, allow issues process in more to provide to manner. can resolve the case, comments? particular any this be additional for basically generally in I and and of think this review with that's in interaction basis quickly, move a from more And a the to benefit able I program. a regulatory prompt think quickly type

Mark Eisner

No.

I disease medical and well need. the FDA pediatric would was I help potential stated, pamrevlumab better designation the patients think to that the this I with both fast unmet outcomes high track rare speak high say medical to Enrique. of the unmet with and from mean, need

important terms of how the us enrolling another way these studies helps it highlighting think of I it's trial, because are. in just

on and expeditiously. I it's to enroll trials focus for overall, think ability to So a it our real doing these positive

Unidentified Analyst

Great.

Operator

that Andy Thank of line you. we the have The next question from is Hsieh.

Your line is open.

Andy Hsieh

my for question. taking Thanks Great.

China two So the regarding questions I have for market dynamics, Chris. maybe

So in of hospital terms the trajectory listings been has very impressive.

is you your of reimbursement thinking kind even am to terms single in is is of that? some for there about just reach that to dynamic, XX% I kind cuts XX%, am the about drivers thinking line? as I terms natural by preparing high in you. of year that of in every to what terms China are revenue grow the what kind wondering just the XX%, also government. team periodicity going of the continuing scheduled mandated And I of curious, from about FibroGen team pricing the Thank of XX% of think So kind

Enrique Conterno

Yes.

year, negotiation will will also is you for think NRDL. that when would I indeed forward there that And increase, address to not I comes the made Chris? negotiated. revenue China. done growth how years, listings, to terms given hospital have We I with every much tend contribute. in we to, the there say question it every is two some for think of both Chris I products questions And then about every will have well although going continue to a year in product happens a how be drivers limit

Chris Chung

Sure.

of So hospital think first market question, the to as listings answer we access.

in it hospital no you list formulary, can So dispense. a until physician

need one of So once the prescribers to roxadustat, at you the a still you get the foot your time. in convert door, case in

say, in let's there are department. So XX a nephrologists

might get single You you might there's trajectory. patients. XX the And day, for you prescriber, get don't and next five. every an get XX The all say, hopefully, XXX upward in have first they let's

the get if vast the get If we on you XX patients. the majority don't there But might were to then arc vast you you day, successful, some would is you XX%, the get trajectory. majority their love might first XX%. of the Obviously, we XXX and might also to get get of prescribers and

of really we of hospital very, at we listings market to bode are adoption. in beginning well see in very, foot roxadustat. the our very future So very the But adoption the we door have of to getting success for terms

very is makes market of the the uptake. hope which of access that that the potential could prescription. means XX% actually that sense. But doesn't So, get to XX% good, mean that's end I that

single Enrique second It's every years. with The renewed regards correct. question to is NRDL, two actually

price in the XXXX will obviously the are effective a of in will would negotiations There be factors So up become XXXX. price. QX and for of roxadustat they in new price that number consider

First is of impact budget healthcare the roxadustat the budget. national on

how proposition the actually how how adoption is is in third And and costs the market the really save this It value price healthcare of much price one negotiations. remain the To clear, be way. goes down. in only prescribers in always It up. goes outcome is and we second other value much many factors proposition. in never value of drug. the We confident strong The goes

come it of The single they So up was XXXX it's determining they how one criteria NRDL much discretion yet different and has announced. pricing. how with prioritization been XXXX. The value year, down. in criteria of eligibility not the Every different of set and a for comes XXXX from terms the it

AstraZeneca effective value that years will closely confident We remain thereafter. for QX the this are demonstrate at outcome the be very to about working very we two of access our in market for good price and with a drug of year

Thane Wettig

China If of China Hi. question. some piggyback your really on and first hospital above answer and over just This snapshots have on then is Andy's more that time trajectory could things and color to we revenue first provide Chris, the the around I listings this to provided maybe granularity Thane. performance some of on is nature.

the into we a a at thing taken we add the market really you we in a which provided, share of responsiveness And the then of calculation, is share value-based promotional have are this just category. volume is provided, a ESA XX%, take comments, market. and that's a the a to also, market And off, of have U.S. the our you dosing are significant it's prepared to volume-based Enrique in But at turning much, which nature value-based continues roxadustat look much market you the the which to dynamics if to with take that difficult, think And of in launch when other reiterate market it's is, really growth the top it's lower current is share bit to able probably share really on got market when speaks when the we that first potential some it's to that that some the say that expanding category perspective at XX%, given associated China ESAs. we slides the so as penetration nice a said we a read-through to his fair the which markets roxadustat, highlights than have look process upside of Europe. in

Operator

further I the questions call like would to ahead, turn to There Enrique. Please at time. are no back sir. go this

Enrique Conterno

participation up day. the follow Please everyone's you any Thank Erica. have addressed very have our call if Investor much. much you good. investor with We your in questions very rest team not Thank of the your Very appreciate you FibroGen. today's in enjoy call on Relations interest and we and

Operator

joining. all This for you concludes call. Thank conference today's

You may now disconnect.

FibroGen (FGEN) 11 May 212021 Q1 Earnings call transcript