FGEN - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the FibroGen Fourth Quarter and Full Year 2019 Conference Call. At this time, all participant lines are in a listen-only mode. After the speaker’s presentation, there will be question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. Instructions] [Operator

like Tung. conference ahead, Thank now speaker to sir. hand Mike today, you. to would over the your I Please go

Mike Tung

joining Chief led fourth will China quarter Thank joined Thank full Officer; Senior year to Medical good Dr. Peony by Enrique and our Officer; our call Senior and of Yu, Chris Conterno, FibroGen's and Pharmacovigilance; us will our Today's our for Clinical Executive be discuss Vice Ms. the you, call Enrique on be for afternoon, Kouchakji, performance Cotroneo, XXXX. today's and President of Mr. Officer. Development, Operations; by Financial Safety Justin, you and Elias Chung, everyone. President Pat Dr. Vice Chief our Drug Chief

I research enrollment, out and Before conduct forward-looking our would may make business, point initiation, regarding AstraZeneca regulatory trials; clinical collaborations with related like the we our of design, our to statements guidance, other that operations; business of and our to results including activities; and business and financial we our risks and Astellas, regulatory begin, potential commercial results certain results results; and matters. strategies development

report XXXX uncertainties December well Form may current ended Exchange Commission. on statements business the our call today on XX-K actual results. control year the and expectations for with fiscal XX, to as and and annual cause you Securities risks as For our our regarding beyond between the factors made that filed differences and refer We

any FibroGen's information, call format or whether a and today's found includes The Investors to We we'll in no section team, statement, the of for remarks of as update release website. financial webcast www.fibrogen.com. the date. Investors conference Copies undertake available new otherwise. of will the found filings from our then future for lines can our XX obligation and management questions. result website can and of development be these update today's at webcast The days call FibroGen take the section reporting results of today's business a from The press be to your open on forward-looking be

to to CEO. I'd And like with now the Conterno, that, Enrique call our turn over

Enrique Conterno

you, And the new year today welcome quarter I'm everyone. I earnings full excited fourth I call sharing FibroGen's and morning XXXX like shareholders. thoughts to about to good join and by of CEO. role a you this call. forward in value Mike, deliver patients initial and would Thank moving to a give to will impressions. as FibroGen and afternoon areas of initial our my both some few my focus sense to also start

platforms has from of at we two and core do. keeping science patients FibroGen scientific world-class what comes our the success and

thank to an I our today away and of I who of last provide look I Tom forward year. take his Neff, FibroGen to it invaluable contribution founder would for acknowledge; honoring I to making overview this passed his like legacy. Before progress, FibroGen opportunity what the him to is

a getting investment I've accomplished and I team, build I appreciative sense opportunity forward spending company strong and am foundation. the to to community. our the had look of broader challenges continuing shareholders to of our strengths been with clear time has and on the hear and have highly I from what this my

anemia. a our regulatory in first and is unique ensuring world-class has therapy success anemia demonstrated to medicine assessment other to areas chronic one, commercial with great with for indices expansion number a opportunity transformational of of My FibroGen leverage patients roxadustat, in clear. focus: treatment in science potential three of

our And understanding provide pamrevlumab the development number in innovation. three fibrosis, and future to advanced high-value pulmonary accelerating of three, medical CTGF HIF muscular cancer biology indications, locally scientific maximizing and Duchenne and idiopathic two, and of pancreatic dystrophy. Number resectable

commercial roxadustat to move provide of on review opportunity. Before a like I'd XXXX, overall into we the some perspective

CKD progresses. anemia Kidney Disease has CKD common to in anemia increases been patients with prevalence, Anemia rate As worldwide as with and of to or is three Chronic more in grow important. work CKD never stages continues our five associated the

there anemia million are with in our CKD that States. patients maybe And label. based that X.X United are estimate the XX% addressable expected non-dialysis up We on to

Additionally, dialysis approximately U.S. million X.X in anemia patients there are with the

and XXXX, the In continued anemia XXXX. submitted non-dialysis-dependent advances several with filing last U.S. year. And late progress of made PDUFA we the we for of was XXXX. was achieved the recently December XX, significant roxadustat the see NDA date with in and Notably, through critical roxadustat treatment and momentum dialysis-dependent accepted a CKD

and received in to milestone Japan, demand we and in Reimbursement Drug in CKD and Astellas supplemental of our listings in coverage. are the encouraging. partner trade and roxadustat, Evrenzo launched our non-dialysis hospital the name dialysis-dependent adoption inclusion which list, January. approval In submitted has achieved past partner for indication and uptick the accelerate NDA patients anemia, market this a important National In roxadustat AstraZeneca China, an Initial

and we partner anemia Astellas the Europe, of in year. for quarter of non-dialysis-dependent the forward second this Finally, of upcoming look to and CKD submission treatment roxadustat in our dialysis

the with Moving X growth In pamrevlumab a tissue we ZEPHYRUS our proliferative pamrevlumab, factor in factor, fibrosis. program of first-in-class on initiated patients a idiopathic common to in clinical XXXX, chronic pulmonary and Phase disorders. antibody, activity which inhibits fibrotic connective of

all pamrevlumab X for accelerating X we Dystrophy, treatment programs program XXXX. me treatment patients X year. All Phase enrollment unresectable half top also with Muscular in Phase advanced pivotal locally our this in positive the begin of three of are a priority indications program for with Phase is the reported In data we second expect the these clinical XXXX in LAPIS these X cancer. limited initiated year, of of diseases of in options pancreatic to Duchenne and Phase we orphan Last

to in shareholders. and a We are significant patients position for value create

expand candidates. factor XXXX pipeline are in development our tissue on to our hypoxia-inducible advancing Our novel connective roxadustat approved finally biology focused both drug de-leveraging expertise U.S., priorities and and pamrevlumab the getting of in factor growth

you Now, with I'll will of roxadustat. turn Peony, more discussion in-depth who it a over provide to

Peony Yu

Thank of roxadustat The afternoon, good XXXX. the XXXX in in CKD and NDA I to of to accepted year patients with PDUFA our FDA and And was great filing December XXXX. NDA dialysis-dependent everyone. submitted for for highlights. was and a of roxadustat, non-dialysis-dependent the XX, treatment you, review the has anemia both FDA would like Enrique, CKD some December date

in Roxadustat for the was patients CKD of XXXX. treatment CKD in of for the NDD China the XXXX anemia approved in end in NDD anemia of and at August treatment

roxadustat Chris XXXX NDA and an for anemia NDD of update supplemental detail in will for approved when in call In CKD January. go was patients the the this CKD September past treatment provides more FibroGen China. later into Japan, the was submitted she on NDD

the review if With this forward we were and the of to advancing FDA NDA positive roxadustat indication one. before advisory XXXX. preparing been but our there will time FDA's we momentum approval committee expect no we the in U.S. has of hold meeting, at to look an support the end There continue the as year. In are

business success U.S., pave the continue the partner in optimize become we roxadustat to AstraZeneca our and way patients. commercialization accessible to To our for preparation to

currently CKD in address dialysis dialysis. what to patients, III we potentially and efficacy the robust program a profile roxadustat better With demonstrated patients is of believe those can on and available X,XXX a Phase anemia not over large CKD safety than on

compared patient efficacy where the of over and patient epoetin was average cardiovascular a pool of treatment duration years. from key safety summarize positive I and X.X patients dialysis-dependent roxadustat shall X,XXX alfa to had first results

achieved of the each increase ASM the three the reported and in and the levels roxadustat hemoglobin primary the at studies patients, with larger As within dialysis epoetin Meeting pool in intended alfa while hemoglobin were in mean met efficacy analysis, endpoint range. pivotal

had efficacy pool. unlike the without lower transfusion in presence increasing patients roxadustat maintain inflammation. than EPO lowering patients, risk Roxadustat-treated dose requirements MACE+ dialysis risk of ESA, the patient Notably while in

Importantly, less EPO. supplementation iron roxadustat with was with IV required

results are the the patient study first duration average the initiation These dialysis excited particularly and X.X four population. of the Within of treatment safety patients of population, an years. dialysis entered the incident dialysis of during about had we months cardiovascular

in ever We in program, incident enrolled largest X,XXX patients over the population conducted. dialysis this this

MACE+ risk reduction patients meaningful Here we as risk XX% dialysis roxadustat-treated patients. lower safety a epoetin treated lower cardiovascular incident XX% in than demonstrated MACE and a a had alfa

dialysis setting right naïve alfa prior most roxadustat comparison to the for ESA of are study entry. versus epoetin believe the of since appropriate incident is population most high-risk patients and the We

positive Now roxadustat where moving on and cardiovascular I X,XXX key results to safety patients efficacy pool from our over the summarize to will non-dialysis placebo. dependent program. non-dialysis was of compared

treatment, vast NDD placebo a in especially after majority receive As reminder, XXXX the period over label safety XXXX. And comparison. ESA of no ESA the for the standard preferred control change the the is to U.S. patients of

XX% our risk treating roxadustat transfusion change to similar for iron conducive mobilization, mean In for roxadustat compared efficacy level roxadustat was the studies from NDD required in the the hemoglobin Because baseline that to primary placebo. have response with demonstrate minimum was treatment of of stores patients, patients significantly patients and the for required below iron the than to placebo of ESA. roxadustat's with in and with stores iron – ESA reduce lower Phase demonstrate patients baseline X to NDD repletion. in in hemoglobin efficacy to iron we is superior endpoint

we to and risk in XX favorable With can roxadustat believe With respect of number mean to to potentially the while expand a grams treatment was safety, oral of deciliter. achieved and roxadustat and per MACE efficacy MDD anemia placebo of in of of dosing, hemoglobin in cardiovascular comparable convenience ESAs profile, level MACE+ patients. a overcome addition this hurdles safety

myelodysplastic diseases. CKD, continued development for Beyond treatment evaluating the chemotherapy-induced anemia for for roxadustat of while associated anemia, with additional of we syndrome

roxadustat for for broadly. vision is of anemia the standard Our to become care

patients Phase represents anemia presented anemia. is portion of treatment also Last a Phase to-date. from often Hematology population, the global In whose XXXX, open-label left we large in the for roxadustat X the Annual untreated chemotherapy-induced study study positive CIA in Meeting. anemia results the X December, evaluating patient we Society initiated MDS of of a American at

rest were submitted and in basis CKD Canada, Prize Kaelin, We've application adviser the Asian countries. and in great make for anemia this roxadustat. scientists in the collaboration a Nobel Mexico available with prominent the in to to AstraZeneca see including for as XXXX of already of marketing all the which scientific for the submitting discoveries is following roxadustat To of is development three in Will important several countries. the sensing, It team world, medicine months our of our awarded number long roxadustat our oxygen the progress to collaborator partner serve Dr. time

strong to in and to anemia medical nurses improve look We support care appreciate for physicians, forward community's working roxadustat globally. with patients the and the opportunity

recent like I over discuss turn would Chung, the to developments will in to who call the Chris now China.

Chris Chung

company. FibroGen was for This stage year. was Thank a FibroGen year the China. launched also milestone a you, Peony. as last of Roxadustat middle XXXX established commercial

milestone that historical country a was in global it first-in-class was first in the FibroGen first China time drug the in a drug. Beyond history, development for launch for

Roxadustat reduces to NRDL to by XXXX. Reimbursement was X, government market or co-pay portion is the effective XXXX for the Drug added patients critical Reimbursement National and adoption. the January greatly List

the August, earned has in to and oral As will Peony roxadustat for NDD MMPA the unique patients inclusion. extend AstraZeneca in payments believe need Roxadustat already of benefit FibroGen non-dialysis. the to triggered approval of stated by roxadustat dialysis. NRDL milestone greatly the from $XX approved million the reach in we beyond administration

represented of hospital XXXX A hospital process XX%-plus basis, to our priority in formulary on hospital by listed the be government a can to on now potential national a that before reimbursement forward Looking basis. roxadustat done listings. is it is a with dispensed market hospitals. for needs This available hospital be for by drug top

the nature of education. roxadustat, equally an important is Given us physician for transformative priority

China, over making there market this largest the believe are world. in dialysis we China XXX,XXX dialysis for in As population patients in the the potential

a million to X estimate be It to We grow to million to in is at addressable rate. future population with the expected patients. X non-dialysis the low foreseeable anemia double-digit continue in around

in has limited NDD could of base, addressable increase oral iron, patient persistency treatment oral historically population. and the a treatment warning, the and as We Anemia greatly intravenous roxadustat of well rates as ESAs. been expand this nature box to and believe iron absence the

be evolving China an Coronavirus beyond. continues situation to and in

of priority top making our available the employees, roxadustat that our in health sure is to ensuring patients. While is

facility API a of As returned and Tango operations period to our after both drug shutdown. facility have our today product in Beijing short of in

to to to hospitals the conduct situation in will visits be closely. Our and ability continue affected assess physicians we to continues and monitor and person

will over turn provide pamrevlumab on I will now call who the Kouchakji, the update Elias to an program.

Elias Kouchakji

both XXXX, afternoon, XXXX. and the Duchenne Chris the In for granted our you also you good would orphan over Muscular the pamrevlumab as today year pamrevlumab known plan for of like I Dystrophy and last to DMD. on accomplishments drug our Thank and and review FDA EMA with update treatment the the designation

as new and progressive in in developing in treatment in commitment suffering novel has pivotal those year, fibrosis trials option a antibody This our for disease. began and this enrollment our to Phase last Also pancreatic III strengthened we both pulmonary cancer. debilitating our from potential idiopathic the

Phase double-blind advanced pancreatic These Lapis evaluating locally placebo-controlled a studies and ZEPHYRUS, randomized IPF. study; III placebo-controlled randomized resectable are In III and a cancer. Phase and pamrevlumab study double-blind

than disease Lancet In September placebo of predicted; the and the Phase in both; proportion the randomized II were progression two, that data one, group significantly respiratory in last in IPF. published capacity showed decline The double-blind the the vital forced lower year, group. medicine in data of for percent study published pamrevlumab with our placebo-controlled study patients this

Athol difficult move Dr. of Brompton more trial, as pulmonology Phase Phase for our with in our new a forward Wells Royal are as potential KOLs encouraging pamrevlumab interest imagine we a gratified by have accompanying editorial it In shown to therapy of Hospital IPF. we the program, III in is the wrote, II an community

accelerate planning to expand of In development and XXXX, we are pamrevlumab.

now of in our XXX on risk Phase single enroll IPF. and Phase having patient we studies. study. are plan mitigate study ongoing III the two plan enrollment of to change patient And and to This regulatory study XXX our second focused accelerating will we approximately We a strengthen of III to now of a these each approximately add ZEPHYRUS submission,

to going disease patient-reported primary baseline. from and efficacy and Capacity, is and secondary quantitative progression, in clinical FVC this lung include change will the baseline from endpoint and Vital be Forced endpoint outcomes The fibrosis changes the volume of outcomes

approximately trial, LAPC continue the globally III we to this to LAPIS, to XXX-patient enrollment sites will of accelerate U.S. trial. on and Moving expand in activate Phase the

Phase starting Dystrophy. pamrevlumab half we a to also the treatment of trial XXXX, X In a second look evaluating as forward Muscular Duchenne for

EMA discussion design to in the program. and of FDA are with We finalize the the

I will the call for Pat the over now Cotroneo Pat? update. turn our to CFO, financial

Pat Cotroneo

Elias. you, Thank

revenue XXXX. license will momentarily. up made to total adjustment fourth API quarter million of plus Japan, today, was compared development ended million $X $XXX.X quarter as net in announced less for revenue, which XXXX million for The quarter I product for in $XX.X As $X.X current pricing relating the was the revenue December and XX, revenue, to of describe an million

total expenses basic $X.XX were income million of $XX operating or associated same the loss $X.XX milestones share recognition in of year. quarter $XX.X million $XX.X For and million $XX NRDL per period, per operating is net fourth costs for net our a roxadustat a in diluted the and to fourth XXXX share Included and compared and per revenue $XXX.X basic million or the was as last share to $X.XX of the expenses costs and of in with methodology quarter China inclusion million diluted December. and

roxadustat $X.X in net sales quarter recorded of China. the product for million fourth XXXX, revenues In we

quarter to commercial in listed In a prior of to the Astellas recorded delivered reduction Japan. of for establishment addition in approval API we the in XXXX, $XX.X the price and million XXXX fourth

prior a in result compensation compensation of of on original was result XXXX for portion of stock-based for based the set $XX.X as The ended period million Japanese The $XX.X and costs by Included operating Ministry to year. was expense, aggregate Welfare estimated price. aggregate sale the which a of in compared API non-cash Health, which of quarter an QX XX, expenses million, price and expense the $XX.X was million actual an totaling in of XXXX. portion December non-cash Labor the was listed was of same million, stock-based $XX

achievement GAAP, accordance total with a with million U.S. MAA milestone $XXX in million As $XXX recognized milestones we for $XX AstraZeneca XXXX QX our when NDA of filings, probable. comprised of the become milestone from results in in U.S. such connection Astellas of from anticipated filing million the an anticipated related the in and stated to EU

ending on we QX $XXX assuming NDA second latest NDA was earlier noted our $XXX expect accepted Astellas our and review As occur FDA in MAA XXXX. the February range to submission data, milestones of forecast to U.S. submission and these million the on be in the we of XXXX. estimate Based million in to by call, quarter the XXXX cash for in approval this our

million essentially over have of total includes expected milestones $XXX milestones of we ahead, and Looking the mentioned, milestones a already of XX anticipated plus FibroGen in submissions equally months, on between million which NDA million $XXX equivalents, in $XXX receivables. The and deposits, NDA million next the MAA cash XX, on $XXX our December cash, anticipated sale. is million and approvals $XXX.X investments XXXX approvals. restricted first MAA had split At time and

I back And like now over to you. call would the to Thank turn Enrique.

Enrique Conterno

is Europe. time FibroGen. submitted and U.S., in and in In exciting Japan Canada the and Roxadustat closing, an is other for been and this countries has China launching in soon

are and first-in-class and in Dystrophy. locally namely indications, Muscular unresectable three to a idiopathic cancer as fibrosis, high-value We Duchenne advanced committed to bringing pancreatic medicines best-in-class patients pulmonary pamrevlumab new

look reenergize our connected unique inducible drug factor pipeline next-generation candidates. deliver We and of to of scientific growth factor research tissue our biology hypoxia a create to full agenda on to both expertise some

ramp-up in position next in roxadustat financial XX approximately payments roxadustat $XXX the We milestone million cash months. are $XXX and million expected a over sales strong anticipated in as another with

and China, with we commercialization addition, received China. of shared In for outside we XX-XX. partner all expenses roxadustat these geographies AstraZeneca reimbursement development in In

would thank Interim to dedication who to will who that I here the Chairman continue as at team serve. Schoeneck, thank patients we their Board. as served of of for also and to I Jim CEO want improve our lives FibroGen the like

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

Justin?

Operator

from our first from [Operator comes Thank Michael Jefferies. Instructions] Yee question you. And

Your line open. is now

Michael Yee

that on do thought on And accomplishments program. on activation? you're it Is site boots Enrique in resection you focused and what specifically, you notable rate as just pamrevlumab. one on that? Maybe Is congrats the you just an on the could actually could I think that overall XXXX. all comment achievable accelerating was more And pancreatic about to pancreatic interim milestone? Two sort recently. – on doing whether much. that? IPF Is and quite so an questions, just ground maybe of the Thanks that about you talk cancer say get in

have question we you on what in then of which that will obviously and could a roxa, III Phase comment for up what lot around there'll put it you how I'm mind data. coming one looking to on my And you're and there some should context? on keep data your sure of or shortly. compare to is, is Maybe into be much. that so Thanks focus competitors

Enrique Conterno

well Very you, questions. Elias? Elias good. on also actions then on LAPC I'm enrollment, look Michael. to as Peony question IPF. could Thank And the we have ask And both are terms the going what going ask to interim to in as address address taking of I'm to pamrevlumab an we roxa

Elias Kouchakji

thank your you Mike, question. for

IPF site the is the U.S., globally. So first we accelerating in only are the U.S. not of activation as study, all for in

aggressively So all our actively and to and submitting we CTAs are be very European activated. starting our sites

we interest. this asking Additionally sites study. more us some a matter are of with our opening big but their pulmonology receiving the community, fact, And with and are contacted more these sites, about sites community our with are contact active getting little and engaged we are of in we for our investigators we

as heard first be going is you this So this things this doing is again at to European time. studies. And the we are

study is be second to activated. The going

of remind is me? part can second question the -- you Is your

Michael Yee

resection in reasonable an a think data could you do that Thanks. rate achievable cancer, pancreatic Is very get XXXX? or For on interim you point?

Elias Kouchakji

in sites. similarly, the we – after are of are are we aggressively sites going way rolling So the

are as and approval in at We patient Europe same as hard time are CTA to receive to the possible pushing started these as fast enroll us we possible.

to study. patient get reminder, Just already are patient advanced treated this they unresectable this If or to you be before and treated. have prescreened is because be a not they for wait diagnosed resectable they in cannot locally the

our to. everything doing possible pushing are able these and are at we the we So achieve to very time. increased sites -- hard the We same that’s and number expanded of to milestones

Enrique Conterno

I lines for time, the lines pamrevlumab. providing comes more to to in detailed second provide add. when of maybe half trials can this it Michael, this at all year We're to we time it of not time when our comes enrollment, intend

the this we'll We the for as with possibilities are us on a Peony? provide meeting in of the approval. year. request looking at resection to And rate an for second the accelerated of that FDA more one details half

Michael Yee

Perfect, perfect.

Peony Yu

question. you thank Mike Okay. for the

that data. address demonstrated program that ourselves We PHI there's disclosing III year. the I this there safety that that positive Phase to wanted your remind program their questions, -- data are and may aware PHI are To efficacy already another roxadustat is only be

that in And are – and So data. to risk better a a without in seeing ratio. trial, especially who clinical – conduct trial, of benefit you competitors data could we we compare, is one outcome difficult a expect safety demonstrated outcome. favorable variety when has And have very know we

demonstrate comment Clinicaltrials.gov design relevant the over could which reduction and design MACE X of in in the program I with a a X,XXX XX% to reduction label seen in is safety in dialysis I non-dialysis. patients, And have the – we we and the however, that and Phase for a have which what – what clean even of confidence XX% we gaining anemia in patients. have to incident is hope dialysis and on Now, have demonstrated – safety on then MACE+. a placebo X highly treating trial Phase study risk we in size sample comparison program HIF-PHI in on near none Based have

Michael Yee

Thanks.

Okay.

you. will that. for Thank work We

Operator

SVB Thank you. Porges from our And question next comes Geoffrey from Leerink.

now line open. Your is

Geoffrey Porges

give particularly on you? hospital might ramp-up circumstances think through do to the when you be that asking much you do of they questions. think about we are delay launch bit a when you of you'll roxadustat posing little more Chris, to and the to a talk think China, how getting in reduction start to Thank the the you And Quickly, and a much appreciate very chance you could more R&D. particularly could see and formulary another at already. us we bit pipeline. saying what area have the both you institutions? many pretty situation because companies biology a just we see HIF need opportunities the you major go on to your in are, sort would mentioned little of in the molecules And be a But, CTGF of there you least Enrique, investing sense then, good broaden list to to

opportunity So see the further those the around biology pipeline? targets you what the investments is from Thanks. of from

Enrique Conterno

us Chris try good. now. address the R&D to China Then Very question. takes on

Chris Chung

Absolutely. Hello, Geoff.

So I believe your first question was about the impact of the coronavirus.

by So as as in Many an situation. XX we for it's many days the full inclusion after two our shut normal NRD all know, were back before coronavirus were in part of the the evolving year XX work. factories as and uptake And to are companies encouraged immediately earlier, to last extremely early operations. we the China. We the returning know listings things And down reported are in outbreak. to

We as be to will China operations, normal returns regained. momentum the believe

your think guess else's. as good that's I anybody as when happened, is to As

and we optimistic of we with could accounts the product, place We and strength the are strength team the the very generally the that once regain that happens. key team momentum of think we the quickly have in and sales AstraZeneca

the had uptake be demand I second believe particular how Geoff with hospitals? major are will terms doing we in was when and listings of question the in the seen you

focusing of demand we that depends obviously comes the that that again demand of it as demand is, of come how terms big are the in listings listed on listing only in you're if would naturally rate and believe after to we XXXX. on after So

most In to will you, China. is we when approximately expect terms innovative major listings. academic different major terms X,XXX of there as tell of the Roxadustat in are complete no centers hospitals companies in

takes six years historic to you five to for if it hospitals. all all multinationals, data think list the at from I the look anywhere

benchmark it's optimistic that gain we're shorter historically NRDL. not fortunate listings the that the than we into a it after in entry for timeframe multinationals. finish case historically was launch while timeframe that that We been long could what However, a roxadusat. was enough were for took to And

Mike Tung

both level both positive of one the I to It different known Clearly, quite when you, it is of and the biology. Chris. Thank areas particular impressed understanding a to Jeff been been comes this surprise been when that HIF is involved of have, FibroGen number in have that see CTGF has to very we has that and diseases. HIF biology a in coming

So for leverage the is this unique. is, opportunities and explore quite us to

the CTGF And and similarly, in are the likely areas. comes CTGF for then fibrosis cancer to application when it

about speaking and aim here drug have a To new the the able platforms stream be is to innovation clear is edge understanding when I two leading where Now think on very research, scientific develop of candidates. of are we it these to based sustainable signed.

research to very I'm So with excited the year. able everything so this not intend be that of a may feedback Thank -- on you. it we might in agenda And know share second to more this course But providing not we will details provide our about our be more in and interest. that. be -- on we again of FibroGen's best we once caveat do half that for

Geoffrey Porges

much. very Thanks

Operator

William question our comes And next you. from Thank Blair. Hsieh from Andy

Your line is now open.

Andy Hsieh

for all and Great, thank my worldwide. congratulations progress taking you on the questions

clarifying a IPF in kind about question studies. the change want I ask the to of So

what of change just study what study IPF one to So that really the large the wanted understand two dynamic? to two caused understand by regulators wanted Is a -- to -- a of from that identical prompted kind just kind or studies.

Enrique Conterno

from good. study going caused program for go your question two address have relates question in the to the IPF to studies. Elias one to what the Thank to change you Very question. earlier. The I'm

Elias Kouchakji

not studies of single two them. study of a with III the level versus the the time risk by agency. a is So that look do triggered any this development most This regulatory is going of if about that triggered the clinical our it's was is to going take you by internal and in Phase review the studies with two

statistical And that is level to significant. will could significance statistically of reduce required any is the mishaps and happening this highly the that be reach

the that same So at of size that not risk there's to approaches tremendously. a mitigate thought increase as we better And the time risk. assess much study when we the did

as combined for step ensure this see about that that from between Is the continuously that move versus two as two studies. or why program. about we is that studies We study manageable. heard only one single is reasons previously the is medication you we the success the one of for studies increase As risk That And as the to it into are riskier real is not? doing a a study. us

Andy Hsieh

and guys so preparing know you Got detail. on Yes, that. AdCom, have of question for the probably Thank strategy kind a just it. for just potential for the I you curious And company's that. the about

or Just that potential providers, fact just dialysis that again carefully the potential AdCom? might lot at be there's of stakeholders, of given very the the that for payers strategy a the attack CMS plan watching AdCom

Enrique Conterno

Very let for the have AdCom address good. Peony? potential roxadustat. me Yes, Peony

Peony Yu

Yes.

in AdCom with an no the interaction this is So there indication FDA at time. our for

time points We at well will the time a be and submission there the is three will not prepared decision And be during the NDA days DayXX-Letter really the NDA may before of – any we one. sponsor either about are within XX initial of FDA's or review. FDA the AdCom initial time before or the the final inform the by FDA. on of AdCom checklist time if that There possible X preparing lies are of per notified acceptance our or sponsor or where they

Enrique Conterno

this very have are that maybe conducting indication add Peony’s to outcome. given just And response. been regardless a of preparation Clearly to thorough Yes. we we

we're order preparation. best what considered We do And AdCom for have practices that in is following to prepare regardless. to

in but course, address think we may the Of all the that been come AdCom. about at questions able particular stakeholders to

in is progress. work that So

Andy Hsieh

my all Okay. Great. Thank you answering questions. for

Operator

Thank Beatty from Citi. from And next you. comes question our Joel

Your open. line now is

Joel Beatty

questions. the for thanks Hi,

the Phase IPFs Or one that previous of weight trial switch? as And program well? trial Phase II one need about III you anticipate how first from Phase you some to the that from to that program could be trials powering talk is two. will affected the III switched is carry Could on Phase III that do both The successful?

Enrique Conterno

that? related trials IPF. powering III Phase is Very good. And could you Elias the if is and to the question both need address effective to be successful whether how

Elias Kouchakji

Yes.

plan study So we to powered success. this for

came. first our is So that

maintain similarly we're that the that to than size enroll study in study. patient we highly changing of study not study be and the the which we to is the in So planned, that anything powered first

maintain all currently the data of powering IPF this Phase from So the into product approval level based our other from that of intervened. we on a study data of the study. other and And we IIa will Phase IIb two high taking led studies. of to the available is -- that our very the consideration analysis we're have we And

of combined our data. as basis this all We powering So we this combined strategy. our the for all data

has this your question. hope I So answered

Enrique Conterno

to change Phase Yes. Thank need trials both both also making Elias' for program. that expecting have I Elias. III success yes we successful be clearly Maybe and complement need We Joe we're you to trials successful. the us question. a for be the are can successful of increase likelihood to is to

Joel Beatty

of type agreements anything Understood. for unique drug are On And one question. us the with dialysis preparations ask then providers? PDUFA agreements particularly such that if is payment as other you tell the it underway or could roxadustat, I could that about launch

Enrique Conterno

Yeah.

to preparations complement launch that are Let that try that AstraZeneca in for on to And U.S. will it when launch, partner a have the launch. there we about many it to medical AstraZeneca Clearly in we comes working we effort. has me a when really leading comes one for making question. U.S. great address prepare science ensure is have we to that our and highly you're PDUFA. affairs that comments are clearly to And successful aspects

the is what updates drugs evolve a a year otherwise be as to disease in policy PDUFA, every would for or basically has This prospective provides the band. has CMS continued renal payback rule which now for payment know bundle. that provides included that known commonly system and this you add-on end-stage payment the As called

we We believe clearly prepared the and discussion we're in being that to always to a At it rule our dialysis say difficult are comes CMS, looking – when But it to very the position. with we're fully is making -- will sure on I the good evolve. based continue how that segment.

we also We covered Medicare that you particular patients insurance. also Medicaid, on patients of and have to also as of course course patients are and commercial are segment. on the looking know, And through Part-D, non-dialysis-dependent in

and be going ensure are day of product to we is it's charge leading to sure broadly, we the that this – are reimbursed to end – need at the make be to case. going that we is So AstraZeneca the the

Joel Beatty

Very good. Thank you.

Operator

Sachs. our comes Goldman from next you. Thank Paul And Choi question from

Your line is now open.

Paul Choi

not-too-distant regards I commercialize MDS a Thank ask to future. of afternoon, about anemia PDUFA facing, with the potentially and a roxa and to MDS. in want everyone. you, and X for good to for the Phase hearing company is There drug a

the just So then – to an interim adequate for a rates where with the think you in – if early as you I regard that stop I you X on? something there do just can maybe trial interim? you you clarify follow-up. do is separation And could see us the was had you. built independence about design, Phase wondering, Thank early trial transfusion Is trial at an

Enrique Conterno

will the address we an interim. MDS you competition could Peony, on and question have

Peony Yu

Yes. Happy Thanks the question, for to. Paul.

Phase two parts study MDS anemia. We X with have to had – our we have in patients

component We first the the result open-label have a at plan XXXX. is and have we placebo of And presented rest that the is double-blind interim not analysis. in ASH this for in do which time, study disclosed lead control. The at part, positive

pipe, the I of be of on referring must believe that right? in Now competition luspatercept terms the comment Paul, to you

Paul Choi

That's Yes. correct.

Peony Yu

our does Yeah. patients of sideroblasts a program agent mechanism available. positive, our deposits is program And ring it different RS ring also, drug already targeting and is have with whereas MDS is restriction. It a a action. HIF-PHI And that is that only patients, not with with

And while as the parenterally drug other administered. is

and differences. this medical in some area – the of great feel – So wanting unmet of we comfortable unit. an they this obvious to need And the pursue very confident and could program successful are is are very and those

Paul Choi

specifically just potential would the of for you Any are and other you then development could disclosed, color there are program pamrevlumab, But And follow-up broader I offer you. with any maybe aspects as that, about advancing. thinking here you've a know subpopulations? a Great. program regard DMD. which to be Thank great.

Enrique Conterno

as maybe, think subpopulations DMD. here I looking pamrevlumab if broader Elias, So, other provide, And related question Are well? color program? in on is could the some the at we you to

Elias Kouchakji

are Paul, is are this non-ambulatory. So look like, know, you is with discussion not and following EMA, our, At discussion, non-ambulatory are discussion the our see to talking concentrating about program FDA, to study that -- more this as time the including study. population the about non-ambulatory population. we progressing our said there's on the can ambulatory during the And in the the the same say, concentrating that we we on the currently, we're and add as agencies the at But the calls. only give if the this -- looking the time, as guidance will we with in earning we -- how the we study agencies in in this first

Paul Choi

Very good.

Operator

next from Thank you. And comes Difei Yang question from Mizuho Securities. our

Your line is now open.

Difei Yang

taking afternoon. good Hi, for Thanks questions. my

Just a couple.

So regards in meeting, to case, was to the to do you with place, much how if one notice the take outcome expect get? advance

Enrique Conterno

notice? do the advance want the outcome? on address to question you the Peony, is What

Peony Yu

the give XX believe at business I before days actual least usually FDA Difei, meeting.

Difei Yang

the is the bundle. in with or that, commercialization. is dialysis to Okay. -- as thinking your bundle be whether Thank the in D you And the drug to current -- getting you. setting, regards what's setting, next the are your will for closer How not one

Enrique Conterno

that would be we type But to we're bundle we for drug going be to having scenario. Yes. would in both difficult CMS. we but in to add-on be eligible under described, the roxa of as which discussions I'm we it with difficult. or It for to try question. were not. the the Clearly, is bundle, the going to address key believe -- payment, we scenarios, is preparing whether data and that have be the are If predict the

Difei Yang

you. Thank okay. Okay,

Operator

Conterno like call turn Thank the would now back Enrique remarks. for to I you. closing And to

Enrique Conterno

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

Operator

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

disconnect. now You may

FibroGen (FGEN) 2 Mar 202019 Q4 Earnings call transcript