FGEN - Earnings call transcript Q3 2017

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Operator

Welcome to the FibroGen, Incorporated Third Quarter 2017 Financial Results Conference Call. My name is Adrien and I'll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. call weeks available from this website the of two for today's webcast will on be company A date.

Investor Bergman, For will opening President Karen ahead. now I Corporate of Vice turn the Please remarks call over and go Relations and introduction, Communications. to

Karen Bergman

Thank An and to two archive on webcast be results afternoon of FibroGen's the third our everyone call available Events for corporate this weeks. update for Good and website quarter you, financial Adrien. welcome and of Presentations under XXXX. will

today's call update, Chief Chief product Cotroneo, start execution who across recently Officer, Joining who will Dr. Financial Porter, Tom disease and will Officer filing the Executive Yu, who Pat update our indications. our Program new will Seth accepted financial provide quarter. call Administration Neff, in program China Peony by are Mr. Chief on our Vice Drug And by who the Food application third will Fibrosis Pamrevlumab drug President development performance in strategy the programs. Officer review Dr. roxadustat. corporate discuss of discussing and for Medical our

prepared by Clinical research our regulatory expect our enrolment, the regarding and Elias our strategies, be statements business business, where development also results trials, including we Vice remarks, joined matters. AstraZeneca forward-looking certain and design, other conduct this initiation make our for our our financial to open and we guidance, will activities with Astellas, call Following collaborations of and clinical and the President, Pharmacovigilance. Safety Development, Q&A we Drug Kouchakji, On Dr. will call,

our that in current well on quarterly regarding filings filed XX, statements may as cause uncertainties fiscal actual the and the XX-Q Form factors December we including found and of can Exchange the expectations for ended September and you these XXXX Securities with results, and XXXX made risks of We between refer our the XX, to for XX-K Commission. website. period call For business differences today, as Copies be the A control our statement ended our Investors Form section will beyond and team, webcast of reports, our undertake no obligation call from page call Investors be lines our or at again of to a on www.fibrogen.com. include the FibroGen's the to today's result over otherwise. will any questions. information, then developments, Neff. format this to And turn remarks The FibroGen's website, update we'll for conference it's open management new future your and that whether for available answer CEO, the again with pleasure as Tom on to call my replay forward-looking year

Tom Neff

of Thank and The study Society you, International time Congress for in Good double-blind We July from reported has positive all our at highly September. European data presented randomized today. in Thank us placebo-controlled afternoon. these data joining been productive. since Xb you period Phase IPF the Karen. Pamrevlumab Respiratory

roxadustat We also in major milestones achieved our program.

in China. $XX payment NDA the patients in submission CFDA the a our registration with dialysis has This application drug for partner, the new million NDA anemia of earned roxadustat CKD accepted was and in milestone and associated to or from treatment AstraZeneca, of First, support which QX. of our non-dialysis triggered

we in the percent of lung roxadustat I'll that who peritoneal XB of in XX% and of less Phase Astellas from study pamrevlumab was discontinuation observed which results study a experienced results FibroGen X additional IPF XX% data. as decline as our function analysis top completed of impressive positive arm. Today, observations of resulting well safety pamrevlumab dialysis top FEC first from reported a Phase Japan. shared predicted striking week, most the Phase the results. in provide last placebo the underscoring number addition, of some than the line Perhaps, result X is or quarter, that therapy in line In of couple study, was more, what of was Last patients

Another study predicted study's the only XX%, entry safety notable the the result was of dose the These date. this exploratory this in three with are same our of safety the at percent of XXmgs/kg FVC subgroup percent same predicted in any profile to all studies and involving weeks. every results record mirrored companies seen received two of the prior impressive trials

IPF. on have position our bolstering pamrevlumab for further focused been IP We in strong treating

more improvement the reporting antibiotic be in FVC will months. activity study We on next few data

continue as we chemotherapy. Turning label in higher phase patients and rates cancer program, pamrevlumab standard open reaching the in to pancreatic ongoing our of receiving care tumor resections treated to are versus see our X resectability of we end patients study, the surgical

in and are dialysis continue non-dialysis nearing XXXX, pathways globally. NDA and closer accrual NDA to develop respectively. independent the of completion China, full with four trials focused to partners both dialysis to in regulatory Apart and Administration of on to support program. with Europe authorities in We regard X subject trials CKD and path we completion moving for to for filing analysis the and registrational Astellas, with the unique registrational CKD in for versus in With and of and in our multiple and stations Drug CKD ESA the the target this safety and required in now working on roxadustat from Japan we in filing are US, US anemia placebo sufficient Food dialysis number AZ roxadustat, are the in phase of

receiving X IPF cash our Following to mid fibrosis to we greatly in the positive support proliferation platform. value and the to CKD facilitate the committed August, oversubscribed funds on million pivotal in of $XXX very to investment platforms Pamrevlumab possible in completed community reserves our financing increased and first class beyond August HIF in that our are our of these phase the in and Pamrevlumab and from expansion of in fiber anemia then April development we financing studies. million We China support are from delivering roxadustat substantially with we a further late successful creation the data $XXX appreciate announcement in make with

million with today. end XXX million and approximately XXXX final to equivalents. We A of note cash to XXX expect for introductory cash

Gerald development. We of Gerald. are Directors. President, of Executive Gerald a Baxter most of pharmaceutical, time Pacific of us more and commercial to to Chairman, He Officer was years recently, at been XXXX. and business with Board to healthcare strategy Senior comes Abbott had Japan general the for in as Welcome, International Gambro a retirement and President Senior Asia his experience. Gerald Previously, and in areas welcome at management decade, consumer, in pleased XX FibroGen's Baxter than Lema a Executive over

US Latin Thank pleased and and our Pamrevlumab Seth, in America. as you. go experience well will are extensive product now Europe, add Seth ahead, Porter please. East, commercialization, and region Asia to Dr. his Pacific We Middle in status finance leadership strategy Africa, ask I to platform. in discuss of as the

Seth Porter

Thank Tom. you,

reduce phase difference an lower conference disease and These the for arm or the X efficacy a previous positive FVC FVC the average of trial pirfenidone either patients session week Pamrevlumab Summit for patients was method advocates decline, sensitivity Tom portion, one also same care to mentioned, tolerated percent using Pamrevlumab International XX, method study with ongoing to demonstrated of monotherapy time did a monotherapy clinical pirfenidone X.XX. Pamrevlumab the we phase fibrosis a at of well IPF show primary study. primary in percent model experienced patients, the percent observed pancreatic patients week in progression clinicians. significant our milliliters presented one of presented fibrosis. X.XX death cancer, over of in progression, was are trial, and our a months monotherapy. that in IPF combination the of preclinical XX placebo. than decrease compared X intent Nintedanib. as XX% patients that analysis and the or cancer Switching in from only study placebo Nintedanib endpoint from either arm average sub-studies, for pulmonary when As at decrease an the Nintedanib of to standard defined European used millimeters, randomized than Pamrevlumab data chemotherapy. in patients. FVC average this baseline clinical from well trial. predicted lung At and will met were as from compared Pamrevlumab in of Pamrevlumab year, were ERS showed significant is for main ongoing in decline to randomized linear FVC Pamrevlumab XX% either care ascending Xb Respiratory predicted, to administered is week Pamrevlumab and in patients XXX in of the our we XXX analysis Pamrevlumab IPF monotherapy. double-blind the XXX Society to extent be to results either observe The data in anticipate receive combination the clinical treatment measure in IPF XX.X% in we to continued placebo mouse for improvement outcomes by on in oral of Pamrevlumab or treat an of And of capacity published In in This tolerated week results an in also the from significant of more phase Xb presented Study statistically reduction results Phase in weeks. impact and change this to of significantly did Pamrevlumab surgical results in compared of study volume the Pamrevlumab a resectability slowed baseline the receiving this X for the decline X.XX of study Analysis of idiopathic treated standard as of reporting continuing pirfenidone We Congress phase Foundation Pulmonary statistically radiation FVC year. XX. XX induced with placebo this statistically with a XXX these X At population. slope course come. was predicted our to had the in treated greater pancreatic Phase lung change findings meeting, to to September a Fibrosis not analysis in or fibrosis treated and

approach Phase approved Pamrevlumab. study specific DMD the action to of evaluating the therapy specific. in tissue. patient contrast effects In of pancreatic for we are DMD, will In with locally duchenne are targets the label skipping the in team treatment in a leaders reduce a thought Our recently muscular is Switching muscle non-ambulatory mutations the indication to harmful of potential mechanism design our of mutation population, we ability dystrophy, that advanced of patients third for not new and Pamrevlumab exon to open dystrophy patients. this study, fibrosis registrational working enrolling X muscular to path narrowly regulators or be Pamrevlumab

your increase patient We are investigators expressed encouraged advocacy interest Thank for today Tom. and for by quite now groups and in back you this time to trial. the parents, by

Tom Neff

Thank you, Seth.

be Our Peony. will over next the anemia Dr. Yu speaker to program. Peony go

Peony Yu

Thank you, Tom.

first HIF-PHI, you RO class our an coordinated As in for erythropoiesis. roxadustat innovative know, is agent

Phase of large nearly XX,XXX partnership Astellas roxadustat in studies X designed in phase In program, to continue of and patient number requirements have registration XX pleased PKD total been to anemia X we on in accumulate EU treatment PKD X substantial patients. AstraZeneca with four This regulatory has and Our size with program I'm US a program to our and a meet update the worldwide. include jurisdictions enrolled patients data you Phase progress. sample

Tom Neff

Sorry. interruption? Is there an

Karen Bergman

we did lose Adrien, you?

Operator

No.

speaking. still You're

Karen Bergman

Okay.

blip. Sorry, a we Yeah. momentary had

the I fine. we're lines think are well. working Adrien,

Operator

still Yes. is connected. Everybody

Karen Bergman

continue. Thank Let's you.

Peony Yu

Okay.

So sorry earlier interruption. about any

and of I seven number US enrolled the studies. X Phase will the over. Phase to sentence have treatment a patients European In PKD accumulate in start these we patient substantial program, and X data continue ongoing So

independent completed XX first partner, board of This program reported Our Phase our Astellas, has target with most average in ESA they morning was line in recommended XX patients peritoneal and of grams reported X been multiple DSMB to safety the in this range clinical from or the our and study the XX continuation to weeks safety deciliter undergoing reviews the XX XX.X% X of trials. and and top them current ESA ESA-conversion to the Phase result study, along consistent and per protocols. Japan within by again was conducted underwent X without preliminary week, Astellas past the XX.X% correction of by with data well Roxadustat XX. recent roxadustat of in during being tolerated modification periodic previous profile patients. their anemia all jointly review, safety safety naïve maintained levels data patients XX Phase results dialysis FibroGen roxadustat trial. evaluates the the positive ESA the trials In patients, hemoglobin XX naïve first In conversion

the for CKD as in dialysis The XXX by in efficacy news included the X anemia in great far treatment the non-dialysis in this primary review our results roxadustat As and CFDA been we studies, CKD and in from of and the have report patients that X program China, anemia roxadustat safety accepted NPA both Having NDA. the Phase China. endpoint demonstrate over period. also in we XXX both Phase are met for XX-week study studies,

without care. responsiveness efficacy challenge and requirements who This without roxadustat participated X influenced responses subset open dose, both of positive non-dialysis due The of label an received inflammation a were in Summarize, with studies. our the be international ASN, Society American our was differentiation in XX-week unexpected meeting without any in is of of the profile extension. in to hyper poster Week safety demonstrated comparison on Nephrology in with safety trials were dialysis treated The in of no study. this Phase safety is the previous These Orleans consistent continues the and results [indiscernible] inflammation ESAs, or comparable week, dose patients by addition, in patients inflammation the well In and those long-term presentation New important signals and Last anemia titled with durability new in since inflammation. the the were based by from patients or not standard identified. CKD in at four nephrologists. the analyses the consistent response current Kidney results efficacy of of to safety major clinical patients

with with [indiscernible]. the KOLs of patients from estimated on particularly reduction of enthusiasm inflammation. China from met clinical who profile also for an much We the at the XX ASN roxadustat, responses The expressed

trial beyond or advancing are anemia anemia fourth expected for also myelodysplastic in We start roxadustat clinical CKD. in XXXX. US The of syndrome and is the development to quarter Phase X MDS

back plan DS the to We in to We posted and first X/X may on of potentially to to fourth also go indications worldwide. clinical of look anemia call regulatory study XXXX. roxadustat to quarter forward initiate keep Tom. now advances clinical while in I and it like the and Phase you quarter XXXX, other CKD turn

Tom Neff

of Chief our the for Thank through will you, Peony. the Officer highlights Pat? year. now Pat walk Cotroneo, Financial financial second quarter

Pat Cotroneo

you, Tom. Thank

the quarter ended announced XX, million. September As revenue was today, $XX.X for XXXX total

million For compensation Included September for and XXXX an share. $XX.X which the same portion stock-based $X.X per or period, operating diluted expense. ended expenses the result was were aggregate million, totaling non-cash $X.XX was and million million of of operating expenses net loss a in quarter was $XX.X basic $XX.X XX,

recent the million As as of two financings. period had $XXX.X XX, our September cash million XXXX, $XXX.X same in to year, compared for last reflecting FibroGen returns the of net

grade On time maturities long entirely corporate deposits the related sheet, with grade debt of purposes, of investment our investments, than to lease. receivables, primarily two these years. our and cash, For investment of category debt balance building consists equivalents, cash to total term corporate investments cash cash refers fewer consisting of including remaining restricted

fourth NDA submission quarter payment a net recognized for partner closed during August revenue XXXX. China, and milestone the milestone XXXX, of earned as of raised With This in that roxadustat a proceeds of the October $XX we be On milestone from $XXX.X FibroGen our filing license our XXXX. in million. will XX, million financing AstraZeneca

development IPF. pipeline. sheet clinical and/or positive invest study A of in announcement partner the us line allows optimally strong the our results Xb Pamrevlumab Following top our Phase balance from of in to

$XXX $XXX back to million turn to call balance are projecting cash over now in We I will the Tom. a range yearend million. of currently

Tom Neff

Pat. you, Thank

pleased progress be are share to able We to now this would you preview like to our with today. milestones. I upcoming

developed our the to In next an include program Phase over XXXX the expect in unveil study for of first out team Looking study IPF, on [indiscernible]. our input once a pancreatic to FDA we half has XXXX. Pamrevlumab X gain protocols registrational milestones cancer, X in year, Phase in plan optimized we

of at anemia, CKD exciting are all regions. for roxadustat, we development to in an As four point clinical

you We X Phase the China EU will advancing FibroGen, NDA on The as have US programs partner for Japan. IND holder, and in the with and submission progressing MAA partner are Phase our today, support responsible in lead submission. heard as will our the AstraZeneca, while our submitted US in be track. are take the X Astellas studies NDA from

clinical inflammation making we for plans US. myelodysplasia lifecycle the in management strategy, beyond and or especially for related For expanding roxadustat, anemias oncology CKD, MDS anemia into related are development anemia indications

X Phase 'XX. We initiate our expect study clinical QX to in

China, in strategic Western first trial the land dose for patient New indications conditions Chinese partner the hope in me anemia our MDS and XXXX a please. anemia first have quarter is plan fourth and to quarter in agreed XXXX Q&A. on call Karen that For Karen to may to let We expecting and before AstraZeneca this turn calendar. QX back which XXXX. continue a plan With team or the by this on Year, upon oncology-related inflammation anemic

Karen Bergman

you, could Thank operator the Tom, open line if questions. you for kindly up

Operator

first Michael from Jefferies. And [Operator from Instructions] the question Yee comes

Michael Yee

so what be and if recommended of stop much. you to that's DSMB us the the if can know two then with would present the data. expectation on or on the types where think is how When around you you HRCT just Roxadustat, blinded Thanks about Can actually study should be things you comment on commenting no keep there just imaging data. unblended, requirement are Pamrevlumab, one for Questions they're with a changes. you that you about I a what that keeps areas, and could having remind looks problem. was And looking what

Tom Neff

more Peony weeks DSMB follow has then IP and to and This question very for for I in do But the getting we certain period in considerably will longer of what been intellectual HRCT, completed. with IPF offer property, biologics more protection will regard antibodies. up than would and of seven offer generics with patent filings been the or a normally few appropriate of happen years focused get nine property position the question. With can Seth primary protection response on focus past of the way. have on to - the it We filings out prospect the proprietary team estimate and time. terms to filings

three And team so key and think I of gone of IP as done. Pamrevlumab and ago, our members of work days we're two our that most staff almost through analysis IPF and or the

So in I here evaluations that move we the such will to HRCT the as as expect on matters process. step next the

During to is want anything Seth, likely scenario most QX, the you that? probably there. add to

Seth Porter

obviously that's think very phase they we're outcomes, look right, in promising previous X HRCT in study. I the very the interested

and we how so in the XXX and As anxious FDC the said, the remarkably we're between study looks XXX were with regard to to similar data changes XXX HRCT. see

Tom Neff

like would how data are question Peony, you they structured, how Michael's the at, it, to looking they what DSMB characterization. about take do on is

Peony Yu

Michael, to is role as protect consists as it patient of nephrology, and various neurology cardiology their medicine. well And safety. the specialties you statistics DSMB internal know as including in experts

very established these knowledgeable members DSMB in their So, field. are and

studies In member versus it whether treatment safe At as evaluation, the one use the day phase they patient serious safety study which purpose. patient - events they the up data for of by arm, evaluate until And of advise do open other safety totality that to terms the the for data that evaluation. uses as cumulative not the us support they arm. not adverse in at includes end the continue that data US So event were data DSMB data reimbursement the by in sponsors X evaluate and summarized by DSMB look evaluate are transferred studies. words, for we treatment DSMB of They each by on very the from arm, Astellas study we well evaluate first adverse plus treatment the one phase Europe regulatory at to. approval is seventh these that looking X that

Operator

question the Terence comes And from from Goldman Flynn next Sachs.

Unidentified Analyst

has on talk you of steps One, questions. the for the can then that out Holly for China? us Roxa and with can Terence this accepted. are Hi, in is you now I have And about also building NDA actually two outline respect your where been in of commercialization to you commercial next China, footprint

Tom Neff

question were first please, the what asking. you Clarify

Unidentified Analyst

for next in Roxa about commercialization China? steps Asking of the

Tom Neff

The first just process, drug I I question was approval part make about sure want the understood the to asking. you're

Unidentified Analyst

going you're to Roxa commercialize be So China. basically to doing what in

Tom Neff

a level June sometime on Center So, that assessment until next the CFDA. at at drug For by next early top the and of goes sometime then and year we from have think review staff year. May, process Drug Evaluation, We now

planning licenses estimate that will for On now. get in Key September, the side, be has possible Beijing. there as been to here of approval. as year a the commercialization we is ongoing in after couple is the Beijing have we for at next Currently, drug focus years quickly October looking manufacturing are

their of been quarter in China to to in because in about that half production two fast synthetic in first to the also And requested outside factory to activities expect which manufacturers air are and chemistry a licenses Beijing building of Changzhou, have hours by we we In been move XXXX. train doing Beijing. We a API Changzhou, for the the northwest. of pollution have from is Beijing, areas have

matrix in bulk their by far as for Beijing and So and site sites in The providing FibroGen the supplying as AstraZeneca the in will AstraZeneca two in concert at contract team launch those drug medical Changzhou in and areas with for drug, such affairs. is to the manufacturing marketing in China. Wuxi in as activities be responsible

to the so regard activity, amount It's of try extensive very And place is so rollout there that. of is me let a that in summarize just an substantial plan Roxadustat. with to

year or without we level selling so, will reimbursement. in We expect national be first the

as however, more to rapidly more place. more three see we time hospitals two because reimbursement of activities, as level customers and we as we them. timing in expect in get expect Just and and we to over acquire the reimbursement reimbursement of and the are planning years the grants Progressively on can provincial

been more And be talking activities extensively. future in We'll so have very out calls. these planned about them

Operator

Geoffrey of from comes Leerink. Porges question next Your

Geoffrey Porges

on First, about card recruitment was are the or to the year, Roxadustat just an that for the those [indiscernible] what to trials. disclosure. are the make working phase that studies NDA, manufacturing can sources the the accelerate us or can and that Pamrevlumab, process is still supply getting further for the the US that next timeline. the order pivotal that ready to NDA process and/or you manufacturing suggesting the it some some new capacity you in that you you Can recruitment risk in ask of such US I conditional you XXXX tell to Do phase want is about made you've upon for proceed CKD you statement have the X, be you before have to And needs Tom, X? into - continuing are to then trials that start to required they made do those comments resolved secondly, or rate, assumptions

Tom Neff

validation With regard existing in we year for studies expect a to and given higher long-term cancer. with half on X IPF next That really different phase here, do believe time appropriate decided IPF in on is production capable two Pamrevlumab. If version Pamrevlumab. to to contract when activities that the indeed version a in of are productivity existing the commission the at very About could combination, organization. start other program, early antibody, of until them production year We either goes a X make instance we the a manufacturing to of had one of in CMO, Depending activity higher antibody. on approved we with one phase on pancreatic the circumstance ago, next a runs there we we stock year, large relationship and medicines. doing the have

of the We in Pamrevlumab X. the treated percentile reaching some being new antibody with to version will juncture, patients phase prior to of at XXth move

joining primary quite also an are of negotiations We in with interested additional CMO. antibody our of who set have suppliers ongoing

So the that's period, been while. key it's next for that points then has steps process Pamrevlumab over efficient and next relatively FDA version key these would been the and a be upscaling, doing the for sign We've off picture, the static really long-time data optimized been a things progress on are good year. validation and more

Geoffrey Porges

Tom, start of phase in on inventory you will existing just based X to the clarify, process material? of indications both those

Tom Neff

will able to inventory either start study are material the we to anemia There be approved, they existing with the some investors are on addressed don't of both either on respect scenarios come. facts the that driven With based be as need get to that or the later will or questions both at do forget studies. We sometimes hand and but be will where these to upscaling event studies. program,

a count events deliver we're an for mass one we So counts versus patient and that be that's accountable we MACE more MACE have placebo. dialysis and And ESA. dialysis versus to agreed then unique have to of adjudicated patient studies events, for a that's meaning or both as with on one

expect in events we now counts the And in are the months at granulation the timetable versus the placebo As counts looking big dialysis, studies one the teams a looking upon the number, and the get at as it's close. of in portion get better it numbers of But they end dialysis think at performed we over by other a take ESA get these the the non-dialysis. whole we've and each and I incident very as looking because and the intricate to we counts and two single into and just moment so we're get calculation on inflammation, Inside a at on dialysis had need it few versus is the those also needed. which appropriate time. arena are the closer be of number of the we'll all and we'll to cross is as that next 'XX. up we hit forecast adjudication to commenting validating for month of

So that's picture. the

Operator

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

Andy Hsieh

reimbursement question to kind regulatory China about and follow-up is of a This environment. Holly's the

steps. three So it there appears to me are that

a question hit? licensure, have instinctive visibility do and pending reimbursement. approval, these And any by with Do going sort about the are three second So when you of events to reimbursement. to followed has

time So, both full for decisions? like local and getting before it on the it reimbursement actually there's between sales seems approval a you getting book level. possible to lag reimbursement national Is the and

Tom Neff

steps defined. So over to the you've go

I licensure a one both way manufacturers drug where been and in we've The about. one a certainly framework approval think can think is it's given the non-dialysis we another, dialysis useful thing, provide data the is to for review.

a the couple reimbursement, long for practices ways layer for Astra there these and non-dialysis, to is on There's getting to so one Reimbursement, it in and dialysis China. are And making mainly other bulk activities. the downstream a focused is facilities and partner that drug of around drug will history many is the added our approval things reforming on the are is Chinese licensure now. Zeneca for our each the be the there do provincially drug nationally, development in

drug on, China like sales. to. as a various So US to insurance level ten and the every with diplomats is the particularly market But policies booking looks is new terms in other a the small of years, in more what before expect This it not regards sales, there's respect we people you to reimbursement see provincial large pretty the once in other in book a AstraZeneca, is is it is and of gained. being What relates downstream part, shipping small reasons names to amounts is in demand, added. substantial drug to level we're part general have it part, of so market. a soon. reforms categories but private And that in reimbursement have yes, to us national any possible case come for of sales both five frequently as a foreigners, In to also as

on all to primary China do drug reimbursement Our from couple years and process. important. focus events get intricate and is it's of take make approval place it elaborate in for China sell negotiated, and to reimbursement so a in And we China will initial these and expect the

I that does So your - hope answer question?

Operator

question next Beatty from Joel Citi. your And comes from

Joel Beatty

from out data way the to trials phase X regarded the is one rolled first of be So Roxadustat. the will

be trials, second study Given out then more you there we year, at announced left what's they the with to see pools. by show rolled understand in cancer a on statistically last that that to there saw data a in be showing question what it couple the significant more a could or help And that important survival was is week will that that I come grouped the earlier together way same is believe MACE overall later Japan would five number from we could And next is, first benefit pancreatic of us of months so. time. coming or that given over

Tom Neff

inform what's up first that Joel, to in are we so us particularly let Roxadustat whether I'll information. handle had Europe, the question about the in Kouchakji licensed Japan, rights discussion an first be going announcement and cancer at is completed. study it the a in when received time. pancreatic taken to they we And question, reports Japan fact say to just With Astellas. have reported that like your to Dr. coming it's I'll of Japan, within me The when This reflects the the but study address have that respect and here. we the

to because US process, will Japan. the one it's is likely results much and this the a so groups MACE studies. it's in be arrangement, one seriatim Europe, that In in in more announced likely And by of of in be part pooled

on and decided unblinding it for but to executing focus requirement haven't of in properly attempt data both the We make sure, MACE as pooled possible. reporting coordinators and safety general the is as people

that your Europe. Does question, think Joel that's that front after… US the and answer on focus I that, really in So

Joel Beatty

Yes.

Tom Neff

Elias on pancreatic, please. So

Elias Kouchakji

what result now patients completed is GI data. collecting continue of this study currently our out following to in study. year very is the key And in know you a in look study this at as we step so the as next are is results. biostatistician Joel, way our we field discussion these a for know is The in this opinion with ASCO enrollment, is pivotal published beginning leaders our Hi we as that registration at some promising of considered be take could is key a a

very will that cleaning is where next that data, we looking go consistent the are helpful and understandings the as accumulating now still it that the program a we the we program. in we are process. So, have at And process this for we results results in the good of registrational seen data,

Operator

back I'll the to for have call we And this at time. the for closing turn remarks. questions Tom Neff over to

Tom Neff

to Thank our most investors. to and of the to thanks partners, you and all US and all express for in China, joining the FibroGen call today. my I'd teams our like in our to

advancement posted work years. our to in gratified China are be multiple our a across like we see with evening. resources. our in support to on you the time It's exciting have to and management programs of of important an everyone forward look good FibroGen and global progress coming part the the of that indications, I'd and We product afternoon wish to gotten. We our keeping strategic quarters greatly

Operator

today's for may Thank gentlemen, conference. you Thank now and participating and you, disconnect. concludes you ladies this

FibroGen (FGEN) 8 Nov 172017 Q3 Earnings call transcript