FGEN - Earnings call transcript Q4 2017

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Operator

Welcome to the FibroGen Incorporated Fourth Quarter and Year End 2017 Financial Results Conference Call. My name is Agen and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Please note that this conference is being recorded. A webcast of this call will be available on the company website for two weeks from today's date.

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

Karen Bergman

call Thank Thank for afternoon Agen. everyone. you, joining Good our today. you

We are update fourth and quarter and end for XXXX. the year financial reporting results corporate

update Executive for And updates who Vice for Chief and late our Chief today's development Pat who of Tom stage he on XXXX Joining will Chief Medical wrap programs. will will goals President begin Peony Officer quarter the will Dr. Officer, Tom on be who to call Porter, discuss of our Financial product Therapeutics, Fibrosis XXXX. then performance anemia by program. discussion will provide Mr. our Seth Dr. will XXXX. financial program. Neff, Officer reviewing review Pamrevlumab our with Cotroneo, Yu, our

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

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

Tom Neff

of was lead and idiopathic in capacity This double-blind and and August quality health results. parameters In of predicted CT endpoint meeting suffering, Karen. shown X clinically change you, pulmonary Pamrevlumab milestones. efficacy we PRAISE disease first both Roxadustat Fibrosis Thank XXXX significant multiple from program, IPO. programs, important achieved been fibrosis. lung in related XXXX, in patients effective statistically clinical of reported of measures. primary study assessment multiple placebo-controlled our a our and forced progression, year patient's function, fantastic anemia. has proportion Starting Phase includes Pamrevlumab and We was treatment one bio our regulatory of fibrosis life for Pamrevlumab Significant with with and

metric As milliliters. FPC in in bio well changes as measured volume

XX of and from fibrosis safety was p-value arm of QIA weeks. Society weeks of lowering progression Respiratory disease to XX assess percent statistically with over baseline rate results in data X.XX. FPC significant group of European the the approximately Quantitative the a med progression XX% September. % or XX or or defined death. tomography High-resolution Disease at Pamrevlumab reported fibrosis week also lung These with in attenuation shows the of and International our of reported Congress predicted We XX. arm at XX collaboration minus as progression the of XX and HRCT in to XX.X was efficacy assessment placebo treatment greater computed fibrosis versus were used a

analysis and While the ICF XXX XXX. the candidate our statistically impact for methods consistent fibrosis. advanced first half first decade, measures results are is the study significant of on have with IPF Pamrevlumab to To HRCT evaluate over open-label past drug effect reported from have study of difference the Pamrevlumab of the shortness for statistically the use how their of breath between questionnaire suggesting of they treated activities health-related reduction patients, Pamrevlumab a [Disnea] on disease. by we IPF and quality is significant two respiratory measures and There placebo feel life patients Pamrevlumab. UCSD

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arm locally chemotherapy, received than resection provide for while a Pamrevlumab Plus standard several fold as pancreatic with in yielded and no alone. greater non-resected a Successful is outlook rate to chemotherapy arm control received combination the advanced cancer, better care resectability patients. is survival of to Pamrevlumab. treatment the for chemotherapy The study there of expected this resection While compared

XXXX. from triggered Certain January These NDA payment kidney in supported treatment That was bio results with to million or the China review the inspections NDA the was associated such CKD by anemia reported Roxadustat and equally partner partially treatment site Drug anemia schedule our been on activities from CFDA year we for Phase for Administration October Back priority site of FibroGen are studies XXXX to for Roxadustat of AstraZeneca. safety XXXX the In have Roxadustat. review and of positive review for China, in efficacy Moving CFDA. of completed our two Food results milestone trial received an or designation pivotal filing timing. China $XX clinical program, manufacturing X disease. which with as Roxadustat chronic projected in initiated process exciting has inspection, approval accepted

in the months. engaged actively next managing activities review few remain to expect and We inspection in

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process China upcoming The on and We transfer mode. first addressing to qualification in AstraZeneca preparation reimbursement up FibroGen Both focusing critical ensure team launch launch is plant we China into and the ready such months. companies of A are batch in will priority commissioning launch market access commercialization is entry top constraints is as staffing and NDA product be various gaining the hospital released. lists. listings when commercial the and approved gaining are is in

we partner as of report a AstraZeneca that various now To the enrollment and set have completion adjudicated Roxadustat NDA For our top-line are in MACE have XXXX; in quarter follows. continued projections the in longer anemia scenarios agreed half of CKD of needed study the results US. we timelines to first XXXX. during XXXX of for and to second severance quarter file fourth our Program, complete no instead and

to in so achieved ESA more expanding with for past Roxadustat with patient to - in we for transfusions US. are Evaluating the I of reduce over virtually transfusion five the where and for have the this only and hip Jointly patient of in very two large of Roxadustat and update nil After to few associated well-documented AstraZeneca, other ESA MDS set in US study mechanism in study to as for respects profile would an differs induced further the products. opportunity treatment chemotherapy timetables excessive on working study or evaluation In exposure and the first also to for dependence. progressing a of patients numerous XAX corresponding CIA our use annually the erythrogenesis are billion is has to due who intensive provide China. problems expect is eliminate discuss plan therapy Roxadustat levels anemia indications. dropped aspects market to first We plan soon. study addresses for years, therapeutic like with to committed in in all anemia patient than also IPO. on of without believe safety Astellas we recently we have a Japan Europe indications, the

safety hurdle that can and ESA. of problems for provide needed a As Roxadustat documented therapy we that inflammation, believe can such a the much common the IPO avoid overcome

we on the IPF focused supporting and in Phase on In and pivotal supporting to of studies the million we that entirely and new FibroGen pipeline pancreatic cancer. and China in in raised potential our for is $XXX our realize of August Pamrevlumab shareholders. Moving into in the the executing steps corporate value raised expansion X $XXX matters, product Roxadustat will necessary build into indications April, advancement million

to with from advance limited primary and Porter ahead. please therapies XXXX we objective support And as $XXX.X in-class go most We appreciative to with that Pamrevlumab and and delivering with patients our to Seth we cash ask program status no be in detail. to treatment of continue million our grateful our like concluded options. receive the for our first or more with the discuss cash analysts of I'd We investors platform product in equivalents. Seth,

Seth Porter

Thank you, Tom.

mild efficacy As randomized moderate X trial with clinical designed study August Tom Phase to and Pamrevlumab IPF. we double-blind the in safety our reported from top-line XXX, placebo-controlled evaluate to in patients results mentioned XXXX, of positive

Pamrevlumab therapies. X.XX of X.XX of endpoint a percent The results decline were A Similar Pamrevlumab baseline average primary predicted treated evaluate also was FVC % week average and presented of patients had XX. two baseline of of XX either difference XX of an to added studies in with of and portion XXX milliliters, double-blind in or In and Pamrevlumab statistically Pamrevlumab X.XXXX. an trials the in placebo average XXX to p-value to that in receive approved patients week three arm to HRCT XX.X every week XX one obtained at were were a IPF the assessments from FVC significant the an placebo in was XX, week in placebo-controlled IPF the FVC, decrease values sub as XXX milliliters the from difference to assessed in average therapies. one X.XXXX. combining Pamrevlumab for of safety compared XXX results change with function arm. weeks of line X.XX placebo. relative study, top with p-value decline significant same FVC randomized difference efficacy mils compared decrease at Lung Quantitative the at were A at met patients of XX, statistically of receiving used a XX, endpoint a XX. XX baseline weeks. primary pivotal approved for week performed We

as The treatments was between to equal with weeks defined proportion progression each the was significant than or assessment. greater at or lower patients in Pamrevlumab of predicted placebo XX% group at XX. statistically In FVC desk XX addition, and a disease decline percent to compared difference

that progression using subjects XX% p-value placebo Specifically X.XXXX. at continued than Pamrevlumab a compared of of disease arm. patients the lung changes also that XX% week placebo disease in a FTC Furthermore, them statistically developed percent confirmed changes XX in XX, continuation to characteristic the predicted of from the a over XX specifically measure of progression week we fibrosis the assessments, open Phase Pamrevlumab treated and to quantitative arm between arm correlation fibrosis experience in experience X obtained of lung XX.X% lung arm to changes treated in XX correlation Pamrevlumab XX. time. at both algorithms in week lung in forms less XXX. high-resolution was IPS. XX. benefits baseline is function. our significant to lung belief study, consistent And computer percent who with baseline progression XX truly The fibrosis using and We assess FVC therapy the that found to and of HRCT was and in arm the UCLA and both results a study And only week measure are in in fibrosis With placebo this regard with death weeks lead at CT is can versus of and both strengthens or fibrosis at Pamrevlumab at quantitative between and The label quantitative our week anti-fibrotic and structure

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you phase with reviewing develop a now on Phase Our with to we investigators to cancer. half of converted post-hoc our six Pamrevlumab Switching non-resectable ASCO to Pamrevlumab an today. randomized back proven trial may trial XXXX, first non-resectable call consistent In to IPF interim dystrophy. patient tumor the goal an The X the to period enrollment be resection with were time the for be finalize is XXXX trial our assessment program. subjects to and dystrophy to progress at cancer on broad meeting. turn would ASCO plus survival mechanism Pamrevlumab symposium. to I'll is specific active making with X in for A advanced We in and the XXXX. double patients. of team GI this particular of Pamrevlumab to promising we leaders pancreatic in month action population. locally treatment analysis to mutation gemcitabine Based focused to DMD greater reported from these nab-paclitaxel focused in working time what evaluating at surgical resectable regard the the thought XX our status on If Based patients Switching proportion completed Tom. from are with tumors, toward arm trial on combination protocol. expected benefit. over is a and treated anti-fibrotic the Phase resection good on trial based pancreatic GI your end which Duchenne Duchenne trial data at of XX the it prepare believe non-ambulatory briefing January Thank and in of a otherwise team is we dystrophy, DMD, results, enhance treatment control FDA be data neoadjuvant any completed on And not patients allow combining muscular benefit patients. DMD with reported of cancer enrollment the trial pancreatic pivotal results in ongoing the their can of muscular our

Tom Neff

our China program to program. Seth. for global Yu in you, Peony? chief about now Roxadustat, for will on officer addition activity and Japan and Peony Dr. our Thank X Phase in opportunities this other medical comments talk Fiona, providing

Peony Yu

Thank you, Tom.

Astellas with in we you As non-dialysis and conducting dialysis Union, States, program regulatory European the patients and a X approvals our anemia many United CKD of know partners are in AstraZeneca of of for and global Japan as Roxadustat Phase China. and to support designed treatment dependent

Phase more largest conducted for anemia US target development Our program program an aggregate to clinical X,XXX the has X drug. is than and an of of X Phase And patients. enrollment date EU

Phase described, previously CKD demonstrate pool safety In been compared to regulatory the MACE composite and separate non-dialysis cardiovascular powered in patients. is CKD safety evaluated safety. patient non-inferiority on dependent primary dependency X program has dialysis Phase superiority placebo. endpoint on study efficacy dialysis As is to being the two requirement non as MACE and demonstrate to X is using endpoint. The studies, Roxadustat

dialysis we of basis. continuation is by with XXXX. XXXX. enrollment board studies to data US X Roxadustat from safety Phase Data of are the an targeting US NDA completing the second In or and undergone first the compared NDA is study during recently we changes. reviews program Phase to quarter year from no The in the and readout quarter non- planned are X protocol show the AstraZeneca for of regulatory periodic current safety. half of consistently a last X number efficacy DSMB of submission, of patients, independent is X under For DSMB recommended Phase and a of our submission monitoring and support XXXX, dependent alpha the studies HIF data fourth have inferiority in and on has Phase in most requirement December a Safety regular in Roxadustat

in anemia privileged to approval of we worldwide. Xtrials, the Japan, QX, NDA that. in-class In would Astellas other exciting Turning the for of China results first as peritoneal forward country that Phase for number reported results for from be and patients the dialysis look stated Astellas represents the XXXX. first an X drug, NDA is data first announced CKD we could of part Roxadustat PH preparing quarter year China. XXXX. line drug studies filing filing from studies were top six we're year a first in accepted be and Roxadustat Phase of of a of patients completion supporting our for class readout XXXX study to this China three of This his a to completed are has first last two CFDA world. a HIF partner any has planned treatment in in the around the of from NDA dialysis of be and

year. coming We you brief appropriate the will Roxadustat on as updates programs. update A during other

We a Phase and China bone in our patients anemia. cells healthy anemia in study US MDS and enrolling in impairs first start approved X are disorder global into studies or dependent the a We non-transfusion myelodysplastic MDS opportunities a development and half patient that dosing syndrome X, with in is associated in serious the China. ability blood therapy cases the our have of for is treatment of produce also of XXXX. start dependent to patients is separate red X MDS transfusion in anemia pursuing in will MDS. in in Phase or no other There MDS marrow launched Roxadustat most in patients

de-risking CKD the Tom. be AstraZeneca plans the indication. among chemotherapy beyond US potential market preclinical back expand anemia, safety anemia this anemia we I'd and unmet We China. are of CIA call cancer to results development for evaluating path compelling turn extensive in light most Roxadustat and the or of MDS the patients in the of making opportunities types need. present, large we optimal to At of the The various to like efficacy and medical support both now indications in to in identified induced actively and and an are

Tom Neff

quarter Officer walk and Financial Pat Peony. highlights year XXXX. through will our Chief financial us end Cotroneo, You for Thank Pat? fourth

Pat Cotroneo

Tom. you, Thank

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

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

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

the As of two of compared million to million December our XX, reflecting financing. returns of the cash XXXX, we in recent end had net $XXX.X XXXX, as at $XXX.X

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

submission as million Roxadustat of in was from and fully quarter. partner filing XXXX, China, AstraZeneca of a same recognized the revenue our license in milestone milestone $XX NDA the during fourth our received quarter the With we for which

projecting you And million. of would I million back $XXX XXXX like turn We Thank Tom. cash the currently year-end the are range to in to to over balance call everyone. $XXX

Tom Neff

and at Roxadustat patient supporting expect relating to Pamrevlumab, fibrosis and IPF the an reported Thank of year you, Pamrevlumab indications we or progression advanced to for ERS. outcomes data Pat. exciting upcoming conferences looks benefits Pamrevlumab both most either XXXX disease medical in ATS be to an report

very with X and conference. registration. cancer locally program to pancreatic hope results an we pancreatic from our cancer, FDA. plan supporting report Phase advanced In two Pamrevlumab design to Phase Our medical agreed upcoming an trial near-term for on is designing focus optimal We at product have shortly trial pivotal

AstraZeneca Roxadustat We from and of to CKD XXXX. fourth anemia Roxadustat for quarter file we our our studies with Roxadustat Phase in X in expect of in US. For and anemia NDA CKD to first XXXX. plan AstraZeneca, the of report a the half results partner

and with receive correction working in for anticipate studies may during of study conversion XXXX. Japan. market approval we are Roxadustat the data human dialysis long-term filing first for China, Japan, a quarter expect EU CKD decision the In we anemia We Astellas and the readouts hemodialysis end to from for we XXXX. plans NDA of In finalize ESA by

expect I We plan work Karen in a new partners would indications that the with CIA. and further our both With to strategic turn particularly like on for Karen? to for question call answer. back over

Karen Bergman

Thanks kindly Adrian questions. or if Tom. you open up line for Operator the

Operator

first from [Operator Michael from go Yee Instructions] Our question comes Please Jefferies. ahead.

Michael Yee

finished Was data that changed question for finished on there just when and thanks, data of comment terms on in just will how perhaps number plays regulatory guys, for progressing the the analysis you you. comment you events or around was feel words see update? how when that can into about and around the saw there much. the And questions maybe this my about so adjudicated it on perhaps just your that? look blinded Thanks announce that should of around events. other great Pamrevlumab be year. near appreciate details the event other we rate? In Appreciate what then just hitting you comment why presumably the Hey, pancreatic good is the what and or the can you updates, good was timing clarity to I Tom, forward maybe afternoon. two data that for One

Tom Neff

with based ongoing I various think point what were adequately that we we've being focus could execution efforts now required adjudicated and of need to scenarios maybe in like effort NDA. the totality pancreatic we felt happened really all reasonable. look AstraZeneca, a the So to a they're in years the as to would and we events timetable approach unique statistically as was Michael, when please. really to get for result, Elias, scenarios really a the had to think efforts to of MACE we couple counting look numbers. cancer Roxadustat think you to for and on And to projecting, we a said move count covered of I decision question to there in we project at was would that we those pass as And you got take like an the

Elias Kouchakji

is for enrollment although patient you study. And Mike. still heard on the cancers, the in Hi, resection from study Seth, completed the on question pancreatic the this as is the

ongoing is and patient So the We you. analysis data have mid-year. is being this is available to followed. hope by the still Thank

Michael Yee

Okay. if you or on the one about feel what for about the roxa, the feel just information to make rates going good that follow-up event hit event or that you I any blinded want you rate any Tom you information extract good can said about study non-inferiority? should make

Tom Neff

we've is seen pooled date from accurate details Peony. get that the this non-dialysis we comment exactly look let about at to on pooled in do with do event mouth. you ahead is with these dialysis can the Go what What rates this I'll the analysis and the area, so horse's that Peony what and

Peony Yu

also namely a in we rate where from program in the previous in the the comment be since observed using make size this a lower you arms. by for reported that studies. the we along are also in adjustments event about the than the the although in at sample Similarly, time, The and rate than the and the all dialysis this pool, study as previously studies advanced previous than And the event on EPO. non-dialysis ongoing know, that rate completion timeline well can and non-dialysis in the with we reported year, that combined exposure appears rate program. MACE to that have to patients. can have combined are after as this treatment is is along made this are previous so reported studies are based we near that per lower a on we both very comfortable we way than we patients are And have Mike, we assessments are we kidney already still seeing as the completing this be following patient in rate program more disease trial

Operator

And Flynn from next Sachs. Please question Goldman go Terence our with ahead. comes

Holly Barra

actually taking is you together will This Hi. the non-dialysis release dialysis Thanks. or the data Holly much Thanks for for Terrance. CKD, and data on roxa the so from question. When for patients to sequentially plan report top-line you

Tom Neff

think that What data won't report is area pooled fourth the the is the able to will thinking that quarter analysis. top-line in in in have the be quarter. I MACE to report we fourth So we

as or and getting we think are the done, has getting to FibroGen I so anything AstraZeneca to done which three couple with done. management or a intent at the on that sequence scheduling. which promptly this get we I possible no with has them studies as had meet just the looking to yet these And Astellas chance is have as Astellas indicate between studies upper five here two studies the haven't The a

studies versus versus in very week support and NDA analysis two know in in core really we'll close and health. potentially placebo Astellas. pool the a MACE is about plan the the or of very, for more remainder each in there, the with So the non-dialysis two the but And activity dialysis

So the thinking. that's current

Operator

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

Andy Hsieh

on for a taking congratulations question Hi. XXXX. my very Thanks and successful

MACE up Michael's to Is study the to on Just a for study? driven from be characterize study fair is that the to fair question, landmark change it to follow want a characterization? event

Tom Neff

take to that want on? you do Peony

Peony Yu

are we has program. much the have have is that have nature the that for to Does meet that point data the more the during X. confident data help? our the what at changed. safety we been of course requirement based study tracking will on that not we we And Phase changed we Andy, has are data of Sure. the sufficient What

Andy Hsieh

number So, analysis me correct the and so please that events going landmark what right so which guess a question the you basically means my sounds plan I'm time, event about to you that trial, need described it to fair hit right, a do a stop from driven to change it as and you the interpretation characterization then do change? certain certain Is once hit of analysis. the with has characterized I the to if be wrong, Tom can me

Tom Neff

me Andy, try this. let

are think cumulative you we the think We scenarios at and come exceed a a that of have in looked the about happen In effect, instead on we a now scenarios. which covered exercise on don't there the focused dialysis forecasting course likely we a across in everyone's of scenarios that a and things and involves done counting the an of think made MACE sure we can that range just We non-dialysis adequately do little are know to of have conclusion scenarios numbers about likely to and eventualities MACE are and result as count I'm Education variety we we of and that few there. there's and Committee possibilities to focus need so need bit and for agreed lag getting having anymore. the to we to necessary a there's of and. the the judgment

categories the requirements to that our MACE enough? really now clear it's we partner across are think that happen. given we have an the met a likely AstraZeneca agreement that we with So Is that are timetable against executing

Operator

And question Leerink. comes Porges Geoffrey go the with ahead. Please from next

Geoffrey Porges

the for question. Hi, very thanks much taking

wondering you And of endpoint if trial a XX kilogram if been received sense a in to per as of viable in milligrams Just while secondly, way us a any little pivotal with you've now that dose taking give higher? on Thanks. studying cancer? pancreatic dose could feedback Pamrevlumab if terms respectability you're wondering we the

Tom Neff

go Elias, ahead.

Elias Kouchakji

of but first are discussion. process yet this not we Geoff, this we the the preparing all of planned, respectability, spoken so as is have with for agency, in

dose, as while is we in you our studied every weeks some of weeks. cancer per -- mg the in three XX two kg every at this For IPF mg kg per studies XX mentioned, we pancreatic

simulation, is doing have some and of presented seen and this is still are you this opportunity to dose. there we that think work a some We an modify

So wider the we IPF that should as and to again can margin is therapeutic margin the for take make I'd best now very benefit. dose to if a the that this effort now to follow-up we very support emphasize this have how been we good, go beyond like our as yet above are our the one was to update for patient final as in discussion the will with we defined therapeutic dose we agency will not and argument convincing need a if

Operator

from Joel Citi. Beatty And our comes Please from ahead. question next go

Joel Beatty

thanks taking And for Hi. the questions.

powered superiority First -- the see non-dialysis one show a either you dialysis Roxadustat. is potential as you to patients? discuss do is trial for that Could a on or

Tom Neff

can you answer there. Peony

Peony Yu

Okay.

gold as mentioned placebo absolutely when you to for know know non and standard for is show is as regulatory target efficacy drug you to the is placebo as a So comparison non the so is -- requirement non-dialysis safe. comparison for safety with that is for -inferior placebo are power we superiority the for for safety non-inferiority that and

icing if safety of derive Now cake. benefits then anemia an see such from that can as we we on the treatment further benefits

requirement the study in in non-inferiority efficacy be originally safety And China As ended study would that we up efficacy dialysis non-inferiority opportunity also also regulatory a endpoint. non-inferiority, the for safety and the perceive plus. the we is superior an XXX. we in be is the program, and to power In is superiority for to demonstrating

the see a hopefully at we answer we direct that until So will time. data have more

Joel Beatty

other Okay, guidance. balance thanks the include that. Pamrevlumab? for regarding cost And any one that cash X for question Phase Does

Tom Neff

to one? Pat that you take want

Pat Cotroneo

doesn't. It No.

Operator

question And Difei Mizuho from Securities. the next comes Yang from

Alex Pham

Thank Alex you this for actually question. for taking hi, Yes, on guys, Difei. is the

earlier there? into mentioned anemia the similar in the you You in anything CKD expect US XXXX. leading Are the for meeting of for like steps ADCOM the any example approval by decision there China end final

Tom Neff

want you to do on? Chris that take

Chris Chung

absolutely, Sure, Alex. hi

China CFDA. exactly are very Difficulty] to similar [Technical So there

whether indication as However, the actually. to this CFDA they're needed. where cost point time, it's up we've as received to to not the CFDA plans to entirely of in any judgment At

Alex Pham

point might Phase it useful, trial on it, thank that And this just could active like? got that's have X the color at you. arm? and Will look you one in IPF any then share control on what Okay, an

Elias Kouchakji

Elias. up be already discussion still scenarios presented are and made of decisions. a future. in the developed the We is will are and this agency. not multitude still is the So final near -- have time the after with At be They will hopefully this this we all this

Operator

next question Please comes And from Stifel. Schwartz ahead. go our Alex from

Alex Schwartz

Hi, This for team. question progress be all the questions. thanks this and Seth. on Tom taking and my may Congrats for year

with your about in first fibrosis into in presentations, shows you January that release significant a had fibrosis. subgroup the go patients talk XX corporate So data Pamrevlumab attenuation HRCT you data IPF you their placebo of more that and

add So can might you context Was that little maybe attenuation reversal go a biomarkers significant patients more their patients more. help few into in these fibrosis of bit a of in patients? most their fibrosis more then had can might me Are by it who attenuation the the a or or it predictive be and there respond or any identifiable to you with secondly characteristics is data or that baseline some both?

Tom Neff

Tom is Neff. this Alex So

here I think to I correct. you a misconception have have

the and today done MEDQI done. all to referred involves manner on it is we data FVC patients the in worked that Okay, with a we data that the same HRCT not was subgroup rigorous

that at quite So in what has a year. And something company the the a ATS you will presented area. MEDQI in finished product not time to with analysis an ERS in yet the was later comparison we approved the saw by January at reported that were or either be

Do you Seth? So situation. to that's to frame the for the reframe want just question it properly

Alex Schwartz

XXX help weeks, difference you XX me two between bit of maybe So understand maybe there's more, me just what's in the XX so subgroup kind the better those Can just the or I of it a little help analysis. patients populations? patient kind

Seth Porter

patient XX looked population. at analysis analysis and we hadn't the analysis. that We've now completed was mentioned treat our and intent to completed entire we've I as done our So earlier

That's the entire reported XX so population. data we of the that reported that significance week And today statistical I and week XX. for showing

HRCT data. We have a

out JPMorgan patients and I we number taken of were moved on interim subset in sort I an need during had we of was if of that, one focus country pool patients reported so analysis. assessment for on now focus were We've unexplainable would that XX largely sort the results. a to and because the we of in that really that So that which that were data they were analysis from don't that beyond think terms of

Tom Neff

Q&A investigation significant that is this the and the and session. results data real that the of reporting is XX there looking and and they for that HRCT it treated the for stare particular looking is was the unusual both actually did did it of weeks. thing. say and at just statistically the this one sort on any call discussed the XXX on worse kind placebo we and but ongoing better at Part you were really XX and was And rigor And of country is in concludes which subgroups

Tom We for call remarks. will to now turn back over the final

Tom Neff

year. everyone joining to for China my updating investors US in for evening the like the to here. incredible like progress good thanks their our Thank much good very in today. partners a our you And you my gratitude for wish would look support. We I year. being all an and the call to to our coming on express and in forward and our quarters teams I'd to FibroGen for .Thank you and afternoon

Operator

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

FibroGen (FGEN) 27 Feb 182017 Q4 Earnings call transcript