FGEN - Earnings call transcript Q1 2019

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Operator

Welcome to the FibroGen’s First Quarter 2019 Financial Results Conference Call. My name is Erin, and I’ll be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note this conference is being recorded. call Karen the turn now over Bergman. to I’ll Ms. you may begin. Bergman,

Karen Bergman

financial good you call. And reporting update very XXXX. thank quarter afternoon, the Today, and first for much, are our Erin, joining and everyone. of corporate for thank we results you

Joining Vice Neff, and President, and Drug and Officer; Mr. Clinical Chief Officer; Dr. Mr. Tom Chief Pharmacovigilance; Chief Peony Development, Yu, Medical are Financial Pat Elias today’s Executive call Chairman Dr. Kouchakji, Officer. Cotroneo, Senior Safety

will Tom the remarks, Following milestones open upcoming prepared we will discuss call and to Q&A.

our make call, we financial certain and statements this design, including potential clinical During matters. research business, business initiation, regulatory other results; our the with may conduct and Astellas; forward-looking and development our regarding of results and trials; AstraZeneca activities; our and enrollment, collaborations strategies guidance; regulatory

update For to remarks from be We weeks whether a press ended cause our now results CEO, take The no risks will team, financial future FibroGen’s Tom date. information, to made with of fiscal control from Investors to XX-K with Exchange can be and turn over on release section update found Form available Securities Neff. in our call these I’d for the today and beyond management or between call for well results, on Annual otherwise. today’s of on Report refer differences that actual current FibroGen’s the statements www.fibrogen.com. our and new XXXX, business and our development includes two Investors as our webcast then be and to call that, format we factors website Copies regarding and today’s XX, as And may reporting as the our our for The of of a website. business the like the at result conference section the call we’ll The Commission. filings to the and uncertainties statement filed questions. obligation can you your lines webcast December any open year forward-looking today’s found undertake of expectations

Tom Neff

These everyone, are of safety compared Phase are from X,XXX you, studies EMA. Today, on of roxadustat perform. benefit and us. FDA are Thank not ourselves performed reporting where seven CKD dialysis AstraZeneca agreed an results who the MACE who and are topline which alfa, regulators pools to compared are our will results upon and on where by dialysis CKD two There patients roxadustat and for part including Welcome, dependent pool joining overall patients X important adjudicated we we X,XXX into the in Astellas MACE+ broken with epoetin is partners and up thank you as Karen. placebo. the risk patients to assessment the analyses, are and

endpoint that by pre-NDA standards FDA standard In be will the European EU, or defined on consists the In components primary or of safety heart some events cardiac to upon, the time believe adverse we basis MACE topic occurrence infarction regulators. assess stroke death, current Europe, initial MACE is to hospitalization of We is are believe of have also safety be and we’ve and this have most a extensive agreed representing We assessment had for of as endpoint the the to data MACE+, dialysis due setting reporting angina expect important result or unstable incident that results analyzed This of especially in with the suitable In the in our the are based who patients defined care. primary in to-date. which important the for U.S., safety the myocardial and of roxadustat. roxadustat data recently major on of the the plus discussions today we results that non-inferiority ESA. subgroup not margin we first have the comparison dialysis, and the of meeting. as this which most begun regulators finalize U.S., failure discussed we the will on on totality will

shown treatment the MACE+ survived towards risk of a of as patients stable the and patient the for increased came on where first than versus reviewed FDA measured nonetheless, In alfa. of the and results of make Well, and want the to roxadustat, investigation analyzing patients eGFR in measures, in benefit the ultimate as will alfa non-dialysis and has titration. presence started from EMA risk NDD-CKD non-dialysis to life is analysis randomization one substantially epoetin patients roxadustat addition, population, of These supportive function demonstrated between patient as is safety of from we versus such studies. contains time And In to other roxadustat. to patient are that randomized patients CKD hemoglobin who An efficacy highlight would a of highlight own change period to clinical are X,XXX studies to we their non-inferior studies population, epoetin compared clinically as of partners epoetin the our Astellas placebo. the roxadustat XX. to on roxadustat believe roxadustat I of alfa. eGFR initiating data study been mortality, FibroGen. with much patient would profile incident the ESA, we and and the relevant amount the We inflammation We our walk important AstraZeneca, safety robust of analyses. now the ESA measures first comparison and quality that superiority believe and We are to levels non-inferior and there before compared we examined be result our this renal MACE+ after they the in the and changing one analysis analysis the and – first as newly are for strongly compared and who populations over MACE we applicable on of the already shown above at were analyses from alfa you incident have restricted retreatment incident of alfa placebo. is dialysis and like XX their superiority through setting doses approval biases there period believe decisions efficacy our after no dialysis the months And by results MACE placebo dialysis the partner as the stable MACE anemia MACE epoetin results population This several and with meaningful U.S. And in epoetin to difference pooled of was by population in plus MACE+. meaningful use population time XXXX approximately levels of fairest there represent roxadustat dialysis, and roxadustat three below risk. subpopulation and X analysis believe to AstraZeneca partner between roxadustat the clinically dose the pooled to by time noted conducted ESAs FDA in no data, levels was of Astellas. no dialysis-dependent four reduced and were this dialysis Phase trend CKD was difference MACE+ was lower initiate non-dialysis from alfa this for in prior be U.S. patients to the is meeting which to time incident pool to EU roxadustat An our above, there in where therapy. epoetin to twin have analysis, adjudicated for

majority in out safety majority of followed to because the way than placebo one analysis received treatment the day also period. long-term This is add in of the a in from as pool drop able the ITT a view population. Another results were lack on end followed ITT since NDD post the for to is to this patients to this study. test safety NDD as population patients a placebo Patients way the end patients, through collected the the of of were of patients through analysis, the We in long-term longer for some follow-up conservative of periods roxadustat treatment follow-up in the pool with efficacy evaluate study.

were both intent MACE comparable analysis survival address to to and follow-up and results long-term in been placebo. CV free have of was Roxadustat As These MACE+, MACE+. to below one survival and is ITT CV the MACE treat MACE+ The FDA commonly results margin free several to multiple non-inferiority at X.X. analyses the dropout of that MACE with rate. the methods applied the discussed differential

discussion that the from MACE yet which make, is correction apart spoken There FDA. about is these we plan have to various data to with FDA I have with As not a analyses. results,

to be planned So it not happened. has is

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roxadustat decline slower of of as treated XX. results have subgroups from in change above slow the analysis this X.XX versus a XX analysis the difference three over with We significant in eGFR well patients believe months. observed clinically function eGFR observed studies meaningful baseline placebo a of may the treated at suggested statistically NDD and rate over time We in treatment the the baseline roxadustat showed the decline both as manner. in treatment pooled NDD time patients renal eGFR They from patients and pool

data of including understand different baseline over of doses We CRP of efficacy subgroups will of longer-term. over disease progression we Peony other in increased level roxadustat, roxadustat the to of the multiple in to inflammation the of difference the the and describe and have in later have time. pool And are measures measurements statistically degree stratified Yu detail, pleased by confirmed in more the detail quality significant life these in impact of efficacy shown are the to Dr. call. examining by more standard improvement requires as measured where results the presence

are for period October track with submission follow. for the time on U.S. September, European to NDA MAA roxadustat We submission

now regarding to Let China. me turn updates

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population the be the patients in and expect CKD on the indication to to added anemia mid-XXXX. We non-dialysis roxadustat CKD label

We report in of to continue China to closely AstraZeneca prepare work terms of with our partner roxadustat and for in the much launch have to progress.

a has manufacturing a center includes for the in drug both readiness fully Pharmacovigilance deployed Pharmacovigilance China’s by active over dedicated for Our call China, for AstraZeneca place the Commercial and a has of now. for China team The partner product regions access active holder over XX year. Holder on staff field five Pharmacovigilance covering been field which Market is has in infrastructure initiated mid-XXXX. in FibroGen quarter aggressive is in is API Central responsible has FibroGen MAH schedule. been roxadustat a and database affairs Marketing build be at launch, or medical salesforce now China out in numbers which professionals. Authorization or over already will

timeframe. Reimbursement we National confident list it are We NRDL Drug China address launch third about is will A be quarter List. wanted to added the to whether question or

pharmacoeconomic our non-dialysis label are need, qualify medical that XXXX be the unmet only been of for as may NRDL not of XXXX virtue at probability our consideration market roxadustat is by critical State to received. has Insurance AZ considered Medical has Many made Agency approval maximize perceived as into hopeful value, chances can We to us. of Every value, patients, NRDL such for a between admission go dialysis end clinical joint is pricing, and be our agreed priority so to for and which effort the our this upon sponsor. being by team affordability the believe top FibroGen the is of factors yet approval clear receiving in be success. We

We it have expect sense to what a sometime included would whether price of be in by October.

the to disease in dialysis like you expand to with treatment and and review for roxadustat supplemental filing patients partner a and CKD respect patients for our platform of a MDS. opportunities our roxadustat is for last treatment anemia fall. NDA Japan, XXXX for under CKD Astellas submitted the settings. application PMDA NDA to the other in anemia currently update of Finally, Astellas on treatment non-dialysis-dependent anemia I’d work take anticipates and with a moment and or myelodysplastic on of roxadustat syndromes to The

patients We risk in X multicenter patients who the study in lead Encouraged as in have dependent achieved of multinational patients of open-label open-label the completed of Phase proportion independence. lower portion enrollment XX results with by the positive transfusion from our transfusion measured by MDS. portion

the the Phase for double controlled X/X portion have patient China open-label study. ongoing. placebo We begun of enrolling is blind portion XXX study Enrollment of the

pamrevlumab now Turning antibody. to or anti-CTGF

ongoing X one of see in believe earlier Kouchakji a that muscle and patients. non-ambulatory received FDA near pivotal Elias reserve these these We evaluating and data in Dr. to multiple in The study treatment discuss increase parameters recently for shortly. data dystrophy our study with Phase trends examines muscular designation will disease lung data Duchenne in excited We’ll results DMD. function of in plan progression are is function, discuss of more would including We strength. reflection detail the and and to function, supportive the cardiac we extremely support certain of show treatment future. drug orphan treatment year Pamrevlumab parameters.

fast indications, track drug Our and and IPF IPF, antibody the orphan received pancreatic and in has in DMD, cancer. in of has status now all designation cancer, pancreatic designation current three

share. Cotroneo, of briefly loss so detail EPS, $X.XX million of quarter or later I per here $XX.X will CFO that’s the will and in In we our $X.XX in address share Finally, Pat financial provide basic negative per and matters more net reported call. the first XXXX, diluted

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Peony Yu

Tom. you, Thank

program. supporting the pleased safety global cardiovascular the the in adjudicated roxadustat share the of patients. analyses U.S. X topline results roxadustat roxadustat For We in Phase ER, program are CKD pool with see from results we safety you to and these

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patients subpopulation fewer trend there events to of risk is the roxadustat, MACE+. confidence MACE+ sorry, of the interval first In time interval to dialysis on CKD with confidence is is analyses of ratio MACE which and no in MACE+ following believe X,XXX documents MACE+ to MACE+ alfa. over MACE are adjudication the events, better We stable patient of the to the believe process neurology, non-dialysis of Independent analyses in of by in below MACE dialysis, XX% dialysis various Now non-dialysis and and an reduced hazard that applying population a accepted X.X, of adjudicate dialysis for to and the as hazard and all analyses, epoetin the meaningful patients and starting analyses difference placebo dialysis dialysis the In first – are population MACE our patients. chronic patient patient to Roxadustat to XX% population. pools MACE pool in standards collective out was the which safety our pool non-dialysis just events and the dialysis independently epoetin epoetin independent what roxadustat dialysis. In pool, MACE in Adjudication measure I’m the a a objectivity. which of noted. XXXX are above To MACE+ who time no dialysis pool, specialty. third – conducted assignment of is Incident meaningful Collectively, all CKD multiple the the setting toward data neurology a patients a in and we party. subpopulation integrity, as sub non-dialysis-dependent MACE+ who reveal their in conduct is we comparing time results or treatment, epoetin and – MACE treatment the experts and clinical conventionally the alfa patients. difference MACE+ off of alfa, maintain to and of managed relevant as clinically events, why blinded alfa and it’s our the or risk in our believe data in roxadustat in is what we MACE well patients, the superiority dialysis, incident to receive population. approximately pool roxadustat analysis, there between ratio is and risk and in around demonstrate patient In in individual such on based compared objectively to qualify offers determine consisting is clinically X,XXX process the dialysis patients, the there’s the consistently all dialysis MACE+ for cardiology, maintain patients with this and part is process. between ITT to then

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to alfa initiating roxadustat results EPO compared patient dialysis patients populations. alfa the to epoetin of happy in a non-dialysis MACE+ months On hospitalization those mortality dialysis reduce transition favor and compared towards to to roxadustat patients dialysis dialysis of that, time from treatment. initiation is the initiation patients. CKD treatment. anemia from or in superiority relevant four the We of suffer therapy. in epoetin continuing both dialysis dialysis with in of and off time dialysis We safer analysis result What’s anemia coincides could treatment, with favorable the first year in partners to are first treatment very also first incident survived applies trend patients the a of dialysis enable our the to for also often and to first of MACE rate risk During and roxadustat believe incident in the

have the XX analyses raise mean patients, very not and transplant cell gram patients Turning pool ability important need compared roxadustat treated in CKD is their In to. hemoglobin dialysis. both CKD consistently they down deciliter red levels kidney This to the placebo. transfusion studies, to three the of patients to later blood road, for to the roxadustat hemoglobin reduced on per preserve from if to non-dialysis significantly

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We X.XXXX, FACT-AN X.XXXX, also Total safety important observe that in some score that various of measurement dialysis, ESA. p-value the potential EPO, standard pill, FACT-AN we more CKD accessible statistically on patients end X.XXXX, with which in including clinical weeks baseline, VAS with but Vitality with the for benefit parenteral which with the with score with EPO, patients current to make p-value p-value roxadustat when the other subscale with of a route much is limitations. much, safety and [Audio SF-XX care significant have Anemia improvements and has life is from Functioning results treatment Along Putting not of than SF-XX in standard subscale EQ-XD-SL XX comparison to a dialysis. have in these treating has of that quality convenience gold subscale at the Dip] in points together p-value comparison X.XXXX Physical p-value seen,

context has plan, already October timeframe. the safety be of you touch new patients. the for on our understanding this targeting hope announce and in we submission for innovative therapy are CKD and We helpful U.S./EU status of which we’re September, significance roxadustat today. the of FDA in will discussion AstraZeneca line NDA Tom as with We some submission top plans, the about results excited for of an provides potential

We submitted are to also submission EMA to be Astellas, supporting MAA thereafter.

to For non-dialysis roxadustat as mid-year China, anemia, the X our sites, patients. we will CFDI that CKD on label expect include non-dialysis in there study dialysis well inspected be CKD as April, Phase China expanded

in by now In NRDL on later XXXX patients excited As Astellas treatment our NDA year’s dependent under access for roxadustat’s Tom CKD process in We opportunity election for Japan Japan, via September of China. mentioned, that partner NDA decision is this review. we anemia are anticipate the in market year. dialysis this submitted roxadustat about

in For treatment U.S., MDS X/X study, which patients, dependent lower anemia risk Each and in Asia anemia of has patients in patients we an China. have study difference Europe we striving with dependent plus treat an Phase patients make ongoing difficult label run is and Phase the MDS for to X open in MDS in period, roxadustat. transfusion notoriously is MDS non-transfusion are to in in MDS the a another

U.S., in to the patients study. European proportion portion endpoint. completed we transfusion able there enrollment have of MDS dependent of in by dosing Phase the first encouraged XX the the our available label results, portion We open the study, as X of U.S./European large and transfusion double-blind patients are achieve the partners started we of where independence And have already

first call in start that of who have like Finally, like all turn undergone X in Tom. be shortly do roxadustat, as started I’d in patients are to Phase with of XXXX. clinical believe chemotherapy-induced we us are under over study track aware the a on in anemia the our U.S. the trial I to now about chemotherapy. something to back treatments to anemia and would to the

Tom Neff

you, now cancer including clinical on on Peony. pamrevlumab, IPF. our development for additional activities update ahead. please Elias an update us data and Thank on provide for DMD Dr. and Elias, Kouchakji go details will pancreatic

Elias Kouchakji

XX year, one-year dystrophy completed In Tom with with X of I start treatment Duchenne our this you, study. Thank Duchenne mentioned. of Tom. in all pamrevlumab as muscular muscular dystrophy, the open mid-March patients Phase will label non-ambulatory

development to data Mayor function of are in this in with study we analysis in order this the from in function in [indiscernible] rate percent expert year. review Especially, this our administrative population. we with tested an reduction quarter early to inform test, FVC by of data study critical who the This is study. published initiated in baseline when complete a of we after, the opinion indicate pulmonary potential in leaders, one-year And compared the second study predicted the key strategy. Soon results we in our Starting XXXX decline XXXX. later this in of clinical

As fraction, positive percent LVEF the result by for the suggested mean cardiac as function test, a change data left the ventricular baseline. measured ejection from

While in on from decline showed data X% MacDonald of the published mean one-year. XXXX a approximately baseline in by

we the and between XXXX Tandem then LVEF. data scores a we in fibrosis Additionally, fibrosis published by the with showed measure correlation cardiac collected data cardiac the strong and

the the published these [indiscernible] from some these similar in test. to baseline we smaller correlation. we are suggest change of share function fibrosis for and Similarly than our develop from plan was data mean the FDA test in the data muscle advice clinical the dystrophy. MRI from with result planning on Our Based score arm XXXX. in The result showed results upper the our muscular of a Duchenne these to expert, received development this

as X forced to pamrevlumab approximately the gemcitabine and The with XXXX, with second on or quarter indication, to X pancreatic randomization Phase patients, from placebo. to primary advanced forward other XXX are second XXX we planning of trial it track double-blind, pamrevlumab beginning locally of enroll one are IPF of in intend and chemotherapy approximately endpoint in double-blind Moving the with one changed to enrolling our efficacy in either cancer for unresectable as capacity. our patients. nab-paclitaxel placebo-controlled combination placebo-controlled receive Phase the begin We Also XXXX. we in neoadjuvant on baseline therapy enrolling vital quarter pamrevlumab in of

option pancreatic grateful three a call indications, each I’ll these and by Tom, to Duchenne for fibrosis. progressive you and opportunity providing listening. serious Thank represented for cancer the of the are dystrophy, therapeutic needed We pulmonary for you. and idiopathic muscular turn pamrevlumab

Tom Neff

the financial Pat discuss of ahead. please highlights go for Cotroneo, Financial quarter Officer you, first XXXX. now Pat, Thank will Chief Elias. our

Pat Cotroneo

you, Thank Tom.

total million, $XX.X ended was the quarter As to quarter XX, compared of announced XXXX for revenue March $XX.X today, the million for first as XXXX.

same and $XX.X the For or million per million operating loss expenses period, $XX.X and $X.XX negative a diluted was share. were net basic

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

vast majority stated, roxadustat approximately associated previously that these Thank which the anticipated filed you will call our is back NDA filings. with turn year, of considered in MAA which will and I’ll As million are be to $XXX.X payments, Tom. milestone and the this judgment trigger over

Tom Neff

Thank you, Pat.

the Astellas of for fourth expect to non-dialysis said, in China, mid-XXXX add coming you roxadustat our expecting Europe, CKD With In analysis the today, NDA today, with In we support or roxadustat advanced for Japan, October and CV roxadustat in It CKD XXXX approval of CKD we December. months. the NDD non-dialysis XXXX. shared and is you of MAA anticipated a is both Astellas dependent dialysis number partner upon to the a events of dependent QX dependent NDA critical submission dependent of In in privilege in XXXX. dialysis XXXX. updates DD reported that in we safety indications, non-dialysis quarter on actually believe decision dependenct dependent the later to CKD FDA approval for and in for our pooled anticipates label dialysis September to submitting results treatment the

to look turn Karen me ongoing begin and X to to back in our With to pamrevlumab, Phase this let that, and patients. Phase X further advancement IPF study you and period. the our from question-and-answer DMD non-ambulatory For forward LAPC updating findings we to on

Karen Bergman

Tom. for you, please open Erin, lines up Thank the questions. Thank you.

Operator

Thank you. open. with first Michael [Operator question Instructions] Our comes from line is Jefferies. Michael, your Yee

Michael Yee

for FDA? if MACE? That you confirm Good very is think guys. can afternoon. also on clear thanks analysis, confusion required hazard dialysis non-inferior and you. Hey, is whether discuss be statistically for very would give and be there’s which that helpful. on us? some non-dialysis around non-dialysis dialysis for are Can us and the or you can Peony, you that? I the you Thank MACE Tom in And ratios what

Tom Neff

and discussion. have that the we this One margin Michael, to MACE+, a dialysis Okay, that two we parts multiple U.S., where so in there non-inferiority incident the are with are are market, In doing we margin fact identified measures. answer. is are European that the both in non-inferiority there’s the and under not patients. margin reflecting non-inferior These CKD are statistical was as non-dialysis single dependent

discussions new very partner, of with so the phrase indications totality dialysis. CKD addressing incident that of and essentially We’re that previously, been they’re our mindful In not dialysis investigated of evidence. have

safety any of they means encouraged MACE, the people met of see that’s people evaluation we were why that forward. moving And did the it we this for. form meaningful the versus where the not And so results standards are that looking that addressed in idea clinically difference

Michael Yee

So by dialysis What Are and not in right you you meaningful non-dialysis differences? specific way? trending are positive? trending to clinically you be in MACE, do very mean on the

Tom Neff

at trending think, analyses same specific I message our the and regulator back favorably, yet are to on the be Yes, have agree is we’re to there but forth… we where done. with time, There

Michael Yee

just was you was would to analysis positive, – have you definition like But the have what but positive. an which have? trending It of don’t or you it on trending don’t agreement just would

Tom Neff

very think that’s I say it. Michael, to way a fair

Michael Yee

good. Very

Okay. Thank you.

Operator

Andy line your And with question William Andy, your next from comes open. that is Hsieh Blair.

Peony Yu

when clear whether I Michael’s number I used that Yee’s don’t it – and Before we I Andy, to may add very the I to made X.X. question? response know Michael just Tom

way make talking incident clear not to is dialysis below we’re in absolutely it also that ratio. about, dialysis. one, below is it and talking the about hazard hazard the MACE+ for are one want the We ratio in I

you’re below the when we MACE+ except non-inferiority. us of that XX% to in interval, Okay. commonly the been analysis compare epoetin between in upper bound XX% is competence alfa. to of incident when than the that the one. have mean interval And of is hazard the roxadustat standard X.X And And dialysis. to statistical bound you less has state What upper for for time we the confidence are superior I

very p-value. significant have We a

have question? Michael, I answer your help, does So but this this

Michael Yee

Okay.

Peony Yu

Okay. Andy?

Operator

muted. you perhaps Andy,

Karen Bergman

us? call Karen. are you This is Andy, on still the with

Operator

Your comes Citi. Beatty with is Joel, line Joel next question from open. your

Joel Beatty

pooled two required to pre-specified Hi, statistical the Was is there FDA? non-inferiority plan agreed with by this analysis analysis I MACE FDA. on question

Peony Yu

both some with evaluation methods to a So as the have with agreement like for endpoints. as who have Joel, safety well would the is – at the on of we what – in We that who reviewers commonly see. we as with to is the FDA – of we to very issue. us interacted – looking like And the that wanted collected called have both we FDA would of believe oftentimes, have FDA the conscious happy evidence stating of the And discussions but the statistical had it’s our like efficacy. they on data to FDA, at to review safety look you because used as – term the totality that

issue, audit an not to drug. it’s if be – at to I – look So would were would I data of like a to commit it reviewer, is decision I but a look at on before

the and is of FDA and have we then to sure that information provide question. pre-NDA hope for package, will review. we’ll with alignment, be NDA our And I make answers your preparations in to meeting way to the – our upcoming that that that efficient ensure discussing so FDA And

Joel Beatty

analysis, consideration in Okay. it did take rate compare the to the and the And arm then non-dialysis the a how – does question differences event favorably comparator analyses, MACE on into how the rate? dropout in that

Peony Yu

– do all, Joel, we question. good that’s of first so a Yes,

so drug So and drug. really on is tolerated, we patients our have liked because so staying efficacious our well –

know we placebo doesn’t well. work Now all that too

that So a – double-blinded go I however, is and the to this study. remind want everyone is this back

– the – patient treatment have so are in – even do so other not many patients And words, not assignment information.

roxadustat safety even remain and our dropout higher were studies we placebo on evaluation. rate are see who long to patients, efficacy and a the many high And treated who on in placebo somewhat term did have enable patients. We

able statistics However, we we this the this discussed the that’s data FDA. have collected during will be have be anticipation final of the And safety the ITT course will some on and to the are post-treatment analysis. could assessment period of conduct why and happen, patients with to

Joel Beatty

Okay. you. Thank

Peony Yu

have placebo really have, are we our drugs of us I to under we so wanted ITT I – analysis population that be to the a strength the placebo standard And for the in just And able such to gold it in will to considered safety. the wanted conservative what in non-inferiority that that illustrates considered show non-dialysis mentioned – the is we fact the share analysis and relatively patient remind conditions, also safety.

Tom Neff

you ahead. there? are Go Andy, Okay.

Joel Beatty

Yes, hear I’m guys here. Can me? you

Tom Neff

Yes.

Joel Beatty

the caused wrong team I’m confusion. so pressed Tom Yes, and sorry, to it little that the I a button

apologize. I So

question my picture perspective. looking at do it So with has bigger just to a from

from is to perspective arms EPO the non-clinically, You on guess disclosed MACE it, perspective don’t of both clinical not so this you think what from EPO, you no on placebo transitive that a just if know from roxadustat think difference how a is property – of do have about I this and equal versus clinical does between know to I not discordance equality, we kind way the roxadustat this placebo. versus a well correct But is– – about call?

Tom Neff

non-inferior so and very incident it’s and this criteria with to NDD non-inferior, in essentially pool We MACE+, dialysis The pool, findings these this ground because then the comparison are that think ESA, the there in is simpler have over is pool to have you entire non argue comparisons. you statistically no the Well, let’s hard there’s incremental which defined placebo similar, non-dialysis do you that that risk. safety pool have a on dialysis is idea doing with have with the I’m MACE+. work advantage we significant dialysis

don’t is what happens every right placebo they medicines. day with Just have now, CKDP’s

proven It’s unbiased can we than you this. risk expect of have pool, don’t the with population it’s and in partner just with spaces. U.S., We superiority. think be infer not the to population, evidence statistically different evaluate the we an comparison, will non-inferior dialysis if is totality then which In Astrazeneca non-dialysis. our that as So the incremental incident statistical had particularly on we that agreement MACE broader an

MACE+ point different. think I sentences. seems seem view, but of very be but it results. thought to MACE the would look it from lot We it Pretzel say can try our to makes this are so, doesn’t to similar. you way, at sort Its harder one to or And a accurately, describe results the of going this up Logic in So that a it challenge we sort sum sentence of two

that U.S the So a the would do agreed not we have end-point. fact attributed single say with to I

that than ask One entire the with that’s these patients analysis showing that a benefit in or said whether to the work questions incident was, dialysis have conversion some been us the And the differently benefit forever. in entire risk risk see CKD analysis, we dialysis analysis, from you in data. your of you time a basically you review the issue, need the little using spend should defined newly not and EPO populations FDA

Peony Yu

events patients, is we have, dialysis a terms or tied for our give though to Yes. one we dialysis. example Tom, expressing have who even very difference absolute too patients that on I’m just but I at with even analysis use we apologize in treatment MACE fewer, if are there wanted supplement are we just clinically in MACE now to on statistics pool, our much we I fewer roxadustat look fewer to a we bit, in add, I MACE+ compared of it saying meaningful we are this are of fewer though EPO, and saying with mumbo-jumbo, there’s numerically this way little MACE+. in our conservative example, have and data going no patients that

are that’s helpful. So I’m a of, I sort trying hope what little give is this you we to to saying. color

Joel Beatty

that? death, So, in and trending that’s of confirm understand angina not MI, of there comment failure. Or maybe leading to these that measures on are of the data, some on unstable you us that, a just, the be kind of kind components, heart direction? you are hospitalization, totality digging of all Can different stroke, can that helping may right top deeper

Tom Neff

numeric data, MACE+ have I advantage each category. in believe with we So

So there’s five categories….

Peony Yu

and Tom. one Each them, single of

Tom Neff

ESA. Every in clear over one that of advantage them have America we Is now?

Peony Yu

Numeric advantage lower. meaning

Tom Neff

congestive to Fewer myocardial infarction, in events heart strokes roxadustat in ESA versus of Fewer roxadustat ESA your events failures events than roxadustat hospitalizations, ESA fewer due resulting hospitalizations. in versus of fewer unstable of anginal Fewer death. in

Joel Beatty

– And XX condition, clinically life relevant or into super Thank the for should frame? Yes, is time be a that you question is longer quality at of last measures, helpful. that. that’s given chronic just that weeks looking actually about a that this one you

Tom Neff

the to of Peony, want hit studies. you quality life

Peony Yu

Yes.

So you at the same term, measures time, they where XX when to start forgotten quite And feel, difficult report called much a of these of of ago. period actually I the quality subjective to long – how there’s that a life, that couple you patient like patient the bad as quality a on measure was patients, how months of – you life have carry I were over may a that, not patient’s longer only weeks, in to you it it over things it things number is as that how measure study measures because population want with. out also

generally, So reported outcome. to reasonable, is record months very period it patient reasonable three is

Joel Beatty

for questions. Thanks my answering all Great.

Tom Neff

Yes.

Operator

next Terence, your your from that Flynn Sachs. question And is Okay. line open. Terence with at comes Goldman

Terence Flynn

look but think again, from terms had studies follow-up, they they trial Hi, roxadustat thanks the comparison question the trial, for I clear, just MANTA that answer study, anything those maybe I’m your bit different when all of how MACE then to of in different just but they the I Was understand regarding analyses line? dialysis roxa are taking versus how pretty Maybe and you’re separate fewer was population had non-dialysis more ways, that in still versus there all last you a on the rates they across guess of confused the question. of I have And placebo, comparison, placebo one out event one of events actually a do walk I a back whether at looking – little remember at for pre-specified you through in the line-up, didn’t the terms favorable? could you setting. non-dialysis they events compare whether a showed number the

three across consistency you. as Thank that was well? you the again, there pooled studies So

Tom Neff

there’s in to and terribly thinking in describe decided succinct manner so effectively, call a Having the is X.X recognize Terence, timed difficult This MACE+, which of ratio the comparison situation this. MACE was the that MACE+, that results. in describe is how said each in standard measures we result this Yes, area at MACE, we different the MACE time case several is ITT a a a analysis ITT. like most so CV, to non-inferiority about to below a and state

people ultimate partnership X.XX not say or I a management below or of bound involved X.XX And this X.XX below each time like or aren’t group safety these speaking confidence standard seeing these FDA these that because great the our you not. X.X. when as evaluation executive whether strength ultimately post X.XX long in results above partner’s I in mean are, in someone ones that maybe for for they usually will measures and are I asks an be even X.X evaluated, it though that the know that So or X.X or are are

from descriptive Peony, of results something the is ITT challenge because there’s we is or there’s very is stay do body So to We’ve that that as from issue do that’s go everybody that not needs would things have statistical regulatory and felt think certain rate agreement rate different little as like would can OT-X method on FDA ahead that informative. the wanted very IPCW covariates anything from hesitate make on or be an a And our dropout these adjustments. the you and to I of that acknowledgement adjustments this agreement have reviewers you is that’s whatever, beyond about to else placebo ways statistics rate. or been be that dropout an specific gotten that for like analysis presumptuous. OT-XX here? in roxa, very a and placebo suggested with steady any I like we that evaluated. print talking There than bit have as such a

Peony Yu

Yes.

So suggested do specifically adjusted us to exposure for FDA safety analysis.

exposure more events. time one a how of compare do have you the who than many on patients patient you if So, how number have arm another

we make such the why one the is And so that’s evaluations of that when we comparison. ways – ITT so

we our adjusted two when do a assuring time match will we on safety data looks certainly and exposure see Another we the be in again very, there, arms, non-inferior that to way assessment. follow-up very, see this the

Terence Flynn

I maybe just few Can follow-up? ask Okay.

Tom Neff

Sorry.

You – you what have Terence, have it? one is one

Terence Flynn

the X.X, below crystal so three was basis again, you’re or pool studies just population? a when about be each that talking was the for that so I sure. non-dialysis Okay, just that clear on of to on

Tom Neff

and MACE that? add to all evaluation, MACE, non-dialysis MACE+, It’s to Peony it’s you want CV,

Peony Yu

that with is of Terence, … the studies. will we had MACE and based the the regulators agreement is for that MACE+ analysis across be on analysis pool three type And

Terence Flynn

three The non-dialysis…

Peony Yu

The three size total of studies sample with X,XXX patients. non-dialysis about and the

Terence Flynn

Okay.

us more the at are if this about So I’m trying the numbers give I what they you three just across – if detail terms point Like any individual understand look to in studies? studies, consistent the the individual of guess can’t like.

Peony Yu

So across is studies. consistency Terence, there the three

statistical clinically each very important which the three points of – and the individual and And safety you meaningful and end-points to a need hemoglobin are overall for adequate just In fact, achieve in each that I share individual MACE we is met certain trends power wanted events were end acceptable. the have status comparison. – primary of we in to all efficacy of – transfusion, superiority, study that powering studies MACE+ none

this study than we the reporting result individual are why pool So rather is results.

Terence Flynn

Thank clearer. was lot Thanks that a Okay. you. so much,

Operator

Porges Bank line your from question open. is comes Leerink. next Silicon with Geoffrey, Valley your Geoffrey And

Geoffrey Porges

the measure patients incident. could pool of of to the roxadustat in Thank to broken switched seem the could you, you’ve and that strokes stable dialysis roxadustat, apparent MACE+ were because don’t obviously to Peony, on you the the number the in superiority out in we same the providing. MIs you’re about you this benefit however Could number I very and give dialysis patients at trying still a power have where reassurance the dialysis you and as whatever have in to all much or and do you us color deaths, population pivot sense provide you benefit see ask same the dialysis appreciate population MACE. incident add a you what particularly, us you of dialysis stable who on

Peony Yu

drug. all, we think to when yes, stable dialysis we dialysis versus MACE+, the at first Geoff, agreed wanted analysis are [indiscernible] Okay. with design the even conversion help? quite that so a study the look biased comfortable I results, of –between is study But looking safety does we and conversion of at against the that I sub-group by when incident MACE

Geoffrey Porges

population provide deaths lower the the stroke you and rate Could same roxa of patients? that in treated is in MI – the

Peony Yu

Yes.

the that numbers they be So from in sitting but exact I think front not of that one don’t seem to memory, have another. far would me, off I from

Geoffrey Porges

Okay. Peony, could I just follow-up…

Peony Yu

We have lot of here, Jeff. numbers

Geoffrey Porges

Yes, the you’ve about just America, upon overall to the Could North I talk comparison, of rate variances in expectations compared Europe, they’re that understand. also depending you events any whether and seen cetera? et geography, geographic

Tom Neff

clarity asked, one clarify a question Peony, on but Jeff, I you just want go thing. get just think sorry, wants ahead. second. Jeff, I Peony to to the

Peony Yu

Yes.

least to Jeff, we analysis number I MACE, exact so I in not non-bio, to, we willing when dialysis staples conversion each – am we the even – the patients. – time with that reduced the you So at subgroup when the to example, the test roxa was time wanted right? even in pass non-inferior share that for though yes, yes alfa when or we epoetin – to you I’m MACE+ and that giving category, for But patients that – pass we

Geoffrey Porges

mean, the you you take subgroup So patients incident if away…

Peony Yu

Yes.

Geoffrey Porges

as non-inferior The it was remainder consistently. tested pool,

Peony Yu

Correct.

Geoffrey Porges

you. That’s perfect. Thank

Tom Neff

question state I it us, whole No, don’t I the surprised heard think the please geography thing. Jeff, again,

So…

Geoffrey Porges

observed variations could I events by there just comparison want you just arms whether on different you any geography? rate of to at – between were the compared the the look you’ve then when your the to overall that in subsets the comment in And – expectations?

Peony Yu

we – are conducted. submission, they on now But results, are and analysis completed before and be we’re to leasing detail still granular the subgroup the more still between line to Jeff, MDA we needs geographic analysis be top we’ll then. plan are this – at – will fine the

Geoffrey Porges

right? And Okay. event, overall the

Tom Neff

any observe event overall do difference was, Question in Right. geographies? you rate by

Peony Yu

analysis not done by that have yet. geography We subgroup

Tom Neff

Okay.

Geoffrey Porges

Thanks much. Okay. very

Tom Neff

Yes. you. Thank

Operator

Yang And your with Difei Securities. next question comes from Mizuho

Your line open. is

Difei Yang

my to and I for some answers. afternoon, Hi. question. of then upfront, a I thanks apologize slow, I’m trying get may taking be little the Good

three in the Tom it’s patient with we really or population for or DD either you has think maybe focusing on populations, and two, Peony, the discussion just I’m Is getting the DD, a patient U.S.? populations alone. and dialysis NDD about incident possible So with are approval terms dialysis. U.S. we help me there’s could of filing in indication patient dealing Are NDD? dealing three incident

Peony Yu

So Difei, a you, question. thank that’s very good

the drive understanding We mean have have one is discussion initial already the the with patient patient that three – populations we the we – ongoing is regarding is the for FTA. the decision. that incident understanding FDA is three population that dialysis the had will all with indication will believe I discussion, the And that and that under population are bad, is, help be results

Difei Yang

Okay. Thank you for that clarification.

for now MACE non-inferiority Have the think can Now, you for the statistical measurement. the we a or situation forget the EPO? against placebo DD now, indication MACE+ MACE in either status, just NDD we the just about about for if U.S., reached for and

Peony Yu

the So that answer types depends interval. non-inferiority. nice we we already of the widely more safety by got on X.XX anemia use clear crossed we we thing saying by superiority, so when in used non-inferiority. it standard CKD really are upper in for the mean achieving confidence non-inferiority, well of once margin have you we has we yes, is have on non-inferiority conventional margin – we which – is. to we U.S. transparent we demonstrate or off because been about superiority margin the achieved been similar non-inferiority no dialysis, using bound And of reach expressive – have the a are the that. whether And statistically we standards what have And assessment end incident and is is, can previously Difei, that And the non-inferiority, had that for assessment state wanted chain that it in that what not for is we for so If as reason published cardiovascular non-inferiority be we composite standard, it. Europe that the matter we XX% points regulator significant are we believe and what is

Difei Yang

very, is helpful. This very Okay.

life then and ID non-superiority So population? the superiority, or the if you the understanding? I could think measurement ask DD question on said, on right of NDD, achieved patient you superiority Do I a quality see you’ve that is

Peony Yu

if even not Difei, placebo it’s trying do comparing label. for that what go either. when on in does we non-inferior, reason you’re because testing currently as testing quality doesn’t testing sense but we of for of get a dialysis, in make to life, that So going the and mean, focus that as meaningful comparator against is are It’s non-dialysis are against that active quality an superiority, we not life we And a does that I not label mean? have to superiority

we that’s life quality the why focus measures of So our in non-dialysis patient population.

Tom Neff

X,XXX non-dialysis, of okay? patients clear, to in dialysis, non-dialysis, only quality Just not be life in tested in we the

Difei Yang

Thank helpful. very That’s Okay. you.

you the question more that that NDA there meeting. October like have to be update the true? NDA then, plans September, is you plan clarifications you before FDA final my you data But before update Would us on investors something when is file or submission, will have to a analysis, do timeframe. So

Peony Yu

we at FDA. the at do colleague, I’m press not necessary, Difei, release – do regulatory having a a before looking or and my So normally go we when see

see we Wayne I However, when head. his submit investors certainly our we update nodding will NDA. And

Wayne Frost

And or I a that there change timeline now we would or which say time, let is if September meaningful also know. investors in will submission October the assumptions,

Difei Yang

helpful. you. Thank very This is Okay.

Operator

And your with next question Adam, comes line from your open. Stifel. Walsh is Adam

Edwin Zhang

how if first, the This Hi, on A data, confident to this Zhang approved? MACE sync Are Congrats off for we do Edwin based black thanks of for for question. on on questions is taking me, couple box? data. my we the language Adam. label avoid

Peony Yu

Adam, thank you for…

Tom Neff

Adam. Not,

Peony Yu

You’re not sorry, okay, Edwin. you’re – Edwin,

questions. the for thanks So,

have much Now developed – that not target something when have control FDA a certain on puts package they – we what label that is except over, may label. that that we the we’ll a

of quite – now are what various of evaluation efficacy are aspects some terms that has individual compared EPO seeing our will adjudicated FDA this label. to based we time And CV is believe will The based safety safety. we the was And FDA on checked end pretty seen, the endpoint advised we we of chance that that safety. have and have with that fact that we so at box. the had of composite safety placebo, we of with And – studies on when standard the currently in happy look we that the safety be have goal comfortable the that may the those primary efficacy This we on at evaluation are breath, discussed points something of with non-dialysis avoiding the And studies in – think me is result. the FDA. makes increased that a us

will However, depends selected And from placebo at we an there the this were FDA. that the FDA be to. reviewer will what comparator. we input as targeting they the when then assessment – committee is at are chooses advisory really the is on advisory a there But medical the end, if committee,

Edwin Zhang

of as Okay. certainly a In life term of is patient. slower in eGFR or quality you inflamed what the for will targeting open have the like the we in positive at this from Do look we – NDD larger to and the benefit off think the agency, EPO decline, NDD? roxa? you Are treatment, do impressive, market – efficacy to this these we’ll even cut it benefits roxa additional a the think

Peony Yu

Yes.

this So question. great is a

hopeful is the of a assessable that highly to look discussed doctor’s of had they you the with the shots. will consideration, CKD have get combination need pill has each reach us how as with drug are drive office we and evaluate We patients to drug drug And on expressively more at able FDA benefit risk. being into regularly to taken benefit to FDA base this to have not that be and on go advise

Edwin Zhang

full the see MACE we do when to expect And data?

Peony Yu

where very two very, in we are very some that’s with to discussion data, be pool our the be – Right are now, you result, We top places sharing and – good key we’ll we’ll sending one MACE partners with level question. that with drug to major to to And the to which on to. health the the and conference journal which conferences. since in submit we are and just we through is try approved we got data, manuscript of discussion partners get quality, submit

Edwin Zhang

Okay.

Peony Yu

a It of lot will be fun.

Edwin Zhang

question want MACE ask the I you overshadowed to don’t Can DMD, by question. one on you I

Tom Neff

you. Thank

Edwin Zhang

are the unit data? see you. the next you going data, plan And to study, for the kind and regimen your Thank point? will what control When what of the use? is arm And DMD we dosing

Tom Neff

Yes.

is sort is to numbers, going next, the terms Kouchakji your to I of idea Elias is happen right? about a had speak lot we of this there deal, Dr. big a So But this talk what’s – will in think positive to LVEF, an let left ejection ventricular plan. important fraction I

Elias Kouchakji

then data, in data there is from soon population. publishing disease talked And disease and process patient about So the – – same this the we collected are the mentioned important. looking this our be we by that and collect that additional this we to we with step data And very as Tom, we go which we is hopefully data. with in looking FDA to are history the our next on and one after at time talk we will this natural add

Muscle early will was looking which of possible data quick be are would is be that is conference as out, the Society. that pouring done our in this World We for some likely most

Edwin Zhang

Great. Thank you.

Operator

no we questions And Okay. this further time. at have

closing So back like to to Tom for over the I would turn call remarks. Neff

Tom Neff

the Thank this today. very a to part thank collaboration would your hard patients continued of on culmination to our like or These we you all and you development look more. actually and investigators work many wish the believe support. decade partners clinical We everyone investors evening. good of program, for Thank I some good all dedication Thank joining afternoon I’d updated data. our our FibroGen progress also us years keeping on in a data throughout the for call of represent our and for physicians, call. belief all joining and our you have cases in on we who forward and for and measuring participated you team to to our programs, patience XXXX. like

Operator

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

disconnect. now may You

FibroGen (FGEN) 10 May 192019 Q1 Earnings call transcript