FGEN - Earnings call transcript Q2 2019

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Operator

Welcome to the FibroGen's Second Quarter 2019 Financial Results Conference Call. My name is Adrianne, 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 Bergman, you begin. may Karen

Karen Bergman

corporate And Good are for and second Adrianne. you, thank of reporting for XXXX. quarter afternoon, results we Thank Today, everyone. you the call. joining financial update our

call today Clinical Chief FibroGen Neff, Yu, Chairman Mr. me Drug China Director, President, Ms. Officer; Senior Dr. Chris Executive Joining Elias Cotroneo, Pat Officer. Vice are Dr. Operations President Managing Chief of Officer; Tom and Safety Pharmacovigilance; China, Kouchakji, the on Mr. Development, Peony Medical and Chung, Financial Senior Vice and and Chief

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

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

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

of forward-looking our We our Copies of statement site. section of development a these update filings as result future new or Web Investors found may no the whether obligation be undertake information, in otherwise. to any

The date. will release and then we'll today's Investors webcast section remarks available from take reporting includes our two weeks the Web and at management can FibroGen's on open your webcast be business found today's today's a update and site to results from for of conference be team, format call of The The financial the www.fibrogen.com. lines press call for questions. FibroGen's

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

Tom Neff

you, us. you and Welcome for Karen. everyone joining Thank thank

Let's start with our anemia program.

announced our in the the submission timeframe meeting CKD agreement regarding of We with the with we be We the This roxadustat, clarity are MAA September to to previously We agency safety or our meeting on dependent submitted in the reached partner NDA thereafter. the that submission, from October expected and our cardiovascular target AstraZeneca FDA dialysis with pre-NDA refined for both we NDA Europe with non-dialysis our content have is that populations. to October and the arising an pleased an including the analysis. report FDA. timing for with the

these We X or program, in recently from on roxadustat England XX, pivotal and China in New Phase Phase quality reporting X Journal X pivotal dialysis articles the China the well of other XXX. clinical and two scientific non-dialysis study XXX validation the reporting roxadustat publication for China's for as the study Phase July the of announced studies Journal England New of from results publication of of the studies. results regulatory the or approval Medicine China We supporting medical the by two studies research of The as view importance these X

anemia for any approval in China, approval roxadustat first receiving the the in XXXX, world's we and the in of treatment announced representing China December for updates dialysis CKD HIF-PHI. Other patients

approved quarter indeed third in NDD of portion for to the of CKD the expect We non-dialysis be XXXX. roxadustat the indication dependent or

provide Ms Peony minutes further China In Yu Chung roxadustat regarding program. will on a updates Chris few details will provide Dr. and

June. ongoing at of Dystrophy the in Project AOL the conference PPAMD Pamrevlumab clinical treatment or to highlights turn Let's the our X XXX study XXXX Starting Muscular with positive from first muscular Duchenne quarter. dystrophy, in for Phase presented we year findings Parent

lung function, pamrevlumab Phase X function and shall a on suggests study of muscle heart be design seeking program. function benefits on FDA from in potential the guidance Our has the patients. the We DMD treatment

fibrosis For forced primary double-blind of the FVC pamrevlumab pulmonary treatment study idiopathic vital in with the we Phase placebo-controlled of ZEPHYRUS endpoint or of of capacity change XX IPF, initiated the dosing or over X weeks. randomized patient

enrolling are XXX and in patients this have to We study than more study sites we than XXX more expect globally.

of cancer, as characterized to expression. by extensive degree is CTGF related Turning characterized pancreatic high to disease which fibrosis is this a desmoplasia, of growth

effect meaningful As an potential has have anti-CTGF pamrevlumab cancer. to agent the on a pancreatic

therapy locally initiate X or double-blind unresectable in dosing the to of cancer of a LAPC. study placebo-controlled patient randomized for adjuvant LAPC preparing are advanced Phase with pancreatic We patients as new study pamrevlumab

this Elias on, IPF PPMD DMD call, X conference detail. and pancreatic the more at in Phase presented data Dr. cancer our the Later Kouchakji trials discuss will and

a financial quarter. corporate few the and have updates I brief for

Chief Cotroneo detail Officer, provide Our Financial finance call. on on the further Pat later

or In income net the reported second EPS. quarter, per in diluted share million we $X.XX or in $X.XX $XXX share per basic

had million cash. $XXX.X FibroGen As of XXXX, in June XX,

a marketing as welcome as of Directors. planning late multiple stage our experience privileged and Suzanne through Blaug we industry strategic an knowledge deep advance and be member of critical to are and Board will Suzzane commercial We whose is Ms. products. executive experienced FibroGen's advisor invaluable

I Dr. go to on would now the updates to please anemia ask ahead. Peony programs. Yu provide like Peony,

Peony Yu

Tom. you, Thank

our analysis patients CKD And of pool participated and program. from U.S. non-dialysis the primary safety endpoint. than XX,XXX included Roxadustat is dialysis anemia of in MACE for X,XXX Phase countries studies. treatment cardiovascular CKD first the it CKD is Europe the these known largest for in analysis Over global are XX the patients MACE+ for X or HIF-PHI for anemia. as More

FDA and of Phase recently with safety had U.S. good by non-dialysis. our and in cardiovascular the AstraZeneca our in We results roxadustat. very Astellas, with FDA pull X stated pre-NDA MACE dialysis meeting on a with agreement proposed partners, Together we on roxadustat. partner the analysis our confirmed reach As AstraZeneca, the

quickly format, year. With we and can on for roxadustat do have pleased are post this account We agreement differential includes a this large we of non-dialysis submission. time, content as as approach placebo. We targeting are agreement and to the with dropout it moving submission, at are the for October as NDA between an we

EU are the with partner working our program. based Phase preparation on the Astellas, we results MAA roxadustat Europe, For in X on

Astellas submission their from has recently ends to which calendar year March XXXX XXXX. year fiscal timeline updated MAA XXXX,

September. study dialysis NDA expected present decision forward results upcoming conferences medical journals. to PMDA's look Phase In on patients anemia of ASN in roxadustat dependent in this We in reviewed X NDA in peer submitted treatment regulatory this and such November Japan, as Astellas year. CKD is last The in for

two China. U.S. transfusion global are a studies X, MDS CKD. study X patients dependence, clinical and X study beyond anemia We expanding a working in on and In Phase MDS and partners in patients our treatment together Astellas we AstraZeneca dependent have in MDS, Phase non-transfusion ongoing

starting Phase for of We anemia a roxadustat are starting chemotherapy X study induced treating on track U.S. now quarter. this for

I back turn over to Tom. now the call to like

Tom Neff

Peony. you, Thank

our approval. to who Chung, operations Chris, some heads ahead. on like please Chris go offer I'd Next, comments China, ask of in China roxadustat to country first our

Chris Chung

Thanks Tom.

productive quarter China the on been front. It's a

the We everyone May. in to date. factor our I'm Certification have QX with the commercialization a in plant adoption. projecting for affordability widespread roxadustat is commercial been that roxadustat actively share know pleased been Government market of we're Cangzhou, something achieved gating commercial first shipped. news patients reimbursement that was capsules batches that our the critical is for have pursuing. all We of API to

of drug a reimbursed before number taken Historically government. the by is after Chinese years NDA a approval has

be a have to have adoption government case Nonetheless, We roxadustat assumption reimbursement, until sooner included than for strong made later. this we slow. the we we market will case reimbursement rather base a as near-term be secure rate believe for

the treatment and need, Given unmet pathway, the that novel innovative clinical the is scope priority. national of medicines the top our the a access strength medical of to fact data

be in continue we we patients tell should this self-pay advance. in reimbursement the not XXXX early if more roxadustat will and have If too development still available reimbursement by have efforts but included will AstraZeneca the drug is our is the year. obtained, to end will It market, to clarity market with for of cycle,

China. the roxadustat optimistic highly potential remain We for market about in

the marketing, is We continue without the of AstraZeneca in being opportunity. to medical market address the up force build sales scaled field size affairs investments market to and and access momentum

ahead. updated exciting Tom forward keeping months to look I everyone in the

Tom. Now you back to

Tom Neff

you, Thank Chris.

Elias PPMD few the recently update details Moving we at more Phase data on Dr. Annual Kouchakji a Conference the in on will provide pamrevlumab, July. presented X to

LAPC. As well IPF please as go the and progress Elias, ahead. and in our X Phase studies

Elias Kouchakji

you, Thank Tom.

I would muscular to start like dystrophy. Duchenne our with

the the PPMD in As function. of XXXX Tom function mentioned, non-ambulatory at Conference clinical we muscular of fibrosis presented positive XX Phase first muscle Duchenne full Annual X on in patient and dystrophy all cardiac notably, June, treatment primary data year

baseline we X.XX% of to and LVF. leading It mortality is known change the increase is as the versus in in study, showed ventricular what is expected a important dystrophy. in cardiac positive In fraction function estimated mean in ejection decline decline from in LVF, cause non-ambulatory also Duchenne an left muscular note this

in improvement in between these reduction correlation a of LVF literature. presented. was been scientific reported results previously Additionally, in has Neither cardiac and fibrosis

in Demonstrating muscle the decline further of and potential reduction from published comparison to their results Speaking of function the meaningful the life. pull upper reduction rate the lead of fibrosis of patch non-ambulatory patient, we muscle a of X.XX. will of the Duchenne showed mean eventually to muscular in a know data. this [indiscernible] decline baseline in of The dystrophy quality arm change

both were dominant this positive grip and estimated non-dominant and expected hands The mean year in of treatment at decline. Additionally, in population is showed strength a of the results typically with the increase strengthen grip change pamrevlumab. to one score score in

this pamrevlumab well-tolerated. In was study,

excited extremely which trials. of be clinical particularly the FDA of the in the We program. seeking X are limited has Phase by design population, the non-ambulatory on We from been guidance our this subject result to-date shall

to program in IPF. Moving our

randomized enforced XXX X in from To primary results, Phase X safety X seen dosing a baseline endpoint and capacity we Phase studies. have IPF, of patients. with confirm study vital efficacy the We double-blind our approximately in ZEPHYRUS have and in change a initiated placebo-controlled clinical of trials Phase BC

confirm study is well-tolerated. in X progression efficacy placebo-controlled is treatment similar results and the safety which study of Phase positive reported Phase design objective The X previously to the was and pamrevlumab attenuated in IPF to ZEPHYRUS in PRAISE. PRAISE, our

Last turning Pancreatic least, Cancer but the study. I will not be to

This is patient LAPIS or you We pancreatic of the a patient for evaluating standard neoadjuvant are And for it study XXX defined placebo. Phase locally and cancer. on will randomized resection will will study of a to either evaluating and Phase nab-paclitaxel. pancreatic advanced survival. enroll screening In X to as treatment approximately pamrevlumab double-blind placebo-controlled study be as in a rate cancer standard care A X irresectable of gemcitabine care. study this be therapy pamrevlumab randomized overall

therapy can and which of We each provide that dystrophy muscular Duchenne with to pamrevlumab are and a new disease. LAPC patient believe serious IPF fatal

I'll for listening now turn to back you Tom. and call Thank the

Tom Neff

Thank you, Elias.

now will for the financial and the through outlook Cotroneo Pat proceed. our walk please XXXX. Our financial fiscal Officer, of Chief XXXX Financial through second year quarter results Pat,

Pat Cotroneo

Tom. you, Thank

as XXXX total announced for ended million million June second the Aa the today, was XX, compared quarter of for $XX XXXX. to revenue quarter $XXX.X

For were the $X.XX million second or diluted net $X.XX per diluted $X.XX income expenses and $XXX per per million $XX.X loss last same of compared basic share $XX.X million share or and the expenses share and $XX.X of quarter a operating for year. as period, the million and to operating was net basic

million an of stock-based Included $XX.X for totaling non-cash in to compared XX.X expense result June XX, was for portion $XX.X of totaling quarter million a the as compensation $XX.X in million same prior aggregate result aggregate which was expense million was operating of year. the ended non-cash expenses an stock-based portion period of the which a compensation XXXX

the an filings. U.S. million GAAP, from recognition are we AstraZeneca U.S. milestone of quarter, including of and $XXX the relating anticipated comprised the of revenue our anticipated total with $XXX MAA second accordance milestones connection Astellas filing with in $XX in methodology million a in for million the from the NDA In to in EU

probable. to recognition future Out $XXX and we in U.S. was million, required the consideration $XXX.X current Under GAAP of will recognized the be estimated include are million guidelines, recognized remaining revenue balance quarter from periods. the in current becomes will the the be in recognition FibroGen period the not the achievement milestones are depends revenue the remitted achieved. in when milestones timing actually milestones these that payments of The to related upon to when of determination milestone

call, to of ending Astellas range filing in $XXX reported early MAA $XXX Previously, latest $XXX the MAA we cash the this filing XXXX. had NDA on in of to any we for million million. targeted half of forecast, for our to cash increase $XXX estimate million as submission expect to our second would earlier the this million. year with year, fiscal we noted is for Adjusting XXXX October and occur XXXX Astellas As the timing

Given milestone next scenarios. into additional that payments like move the provide I'd could year, to

$XXX range are completed EU and done that MAA associated is million current filing range XX be million from days time, of $XX to cash the and assumption anticipated occur within U.S. $XXX the approximately million. at AstraZeneca $XXX This and for milestone million the our the includes milestones after that ending should ending NDA, submission. will NDA also filing in cash XXXX Assuming paid which XXXX

had XX, time $XXX.X deposits, cash million cash, equivalents, and investments XXXX, FibroGen At restricted June in receivables.

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

Tom Neff

Thank you, Pat.

Let's by key pointing some wrap events up out to ahead.

-- non-dialysis the dependent we anemia dependent in CKD the to For U.S., NDA associated roxadustat the for U.S. and submitting treatment in October FDA of dialysis anticipate our with XXXX.

by partner submitted Astellas We to thereafter. expect EU the our MAA be

label roxadustat China, in XXXX. expect CKD add dependent QX the to to In we non-dialysis patients

anemia of roxadustat this the treatment induced expect We chemotherapy study for our quarter. to X of also in Phase initiate

forward stage Phase you pancreatic including Lapis development the we looking indications For ZEPHYRUS keeping we study. updated activities our progression and are pamrevlumab, initiation LAPC are of mid-to-late of our progression pushing study or to on Phase an in those IPF with and locally cancer advanced X and IPF forward X three

on to design our and year we their DMD, seek of our Phase the program. years X ongoing plan treatment, treatment from In advancing a of third reported guidance now DMD fourth study the X the of having FDA second first patients Phase on and and through

please question-and-answer back that, go to With this session. Karen me turn begin let ahead. to Karen, the

Karen Bergman

up the for Thank questions. you, line open please Adrianne, Tom.

Operator

you. Thank

[Operator session. question-and-answer the Instructions] begin now will We

Karen Bergman

our I for Yee. think set Michael from first are We question, it's

Operator

line Yee, your is Michael open.

Michael Yee

with question. Hey, Can the Two a for an what FDA issue talk topics or not separately, the concern your One your discussed guys. for MACE the most afternoon. statistical were for questions. key to MACE+ Good plan Tom, the you around or important things three Thanks you Thanks meeting? that's regarding FDA? and And non-inferiority on to much. regarding is MACE. the seems or statistics approvability two that issues be confidence the in then, there so about but whether guys

Tom Neff

go Peony ahead.

Peony Yu

Hi Mike. the intended for accomplished meeting, FDA This what is Peony. the meeting. have we we In

the I about important name agreement asked that. will You achievement. or

proposal for a single primary gained analysis on safety have FDA's cardiovascular for agreement well We for as our non-dialysis. endpoint safety primary dialysis cardiovascular as endpoint

this placebo placebo, endpoint between our account doesn't treating is drop of terms being for out MACE way to drop because that that in earlier. analyzed And in the non-dialysis, work know differential the you time out patients anemia primary in and had whereas will to drug placebo a tendency

statistical And method on so, reached that. have we that accounts agreement for

confidence in about results these stated the believe is population confirm and AstraZeneca of that this of asked have high You very Phase safety non-inferiority MACE. we X our At in confidence has on as non-dialysis. CKD do our understanding level roxadustat both time and dialysis cardiovascular with our

Tom Neff

very of what reflected a degree a high Mike, across I lot of team our I team clarity confidence gained coming and out that the would board that add we the meeting. and both was AZs saw of

and how right in everybody done So, to October everything ahead. detailed early moving get aggressively is so there planning is now,

Michael Yee

Perfect. so comments those the statistics Thank for and your much. Thanks and around you confidence.

Tom Neff

Mike. you, Thank

Operator

from And the next question Porges Geoff SVB from comes Leerink.

is line open. Your

Geoff Porges

-- time us in what each between group much. seen groups exposure absolute what terms you where Thank follow-up they of to at it the meeting when relation have of questions. written to run rates agency? and you Can the presumably the the confirm event two non-dialysis that I you adjusted the you or range, other? you you very you MACE Peony, are exposure But, adjust ask And we least analysis. then, whether for already. minutes could have Could mentioned And from tell either analysis you but with to the have first haven't

confident at could that the to you as then, And the change of or Thank European about less European the make that result the meeting. as Q does that you regulator explain application. or amendment a look is any your in to MACE+, you. well And your going is confidence MACE conversation

Tom Neff

Europe me aware on we're first. back MACE+ story last that for the let of. There's deal MACE, Geoff with issue the no

take other think at I value. address So, just Peony, ahead Geoff's please. questions go and face

Peony Yu

FDA our end July. meeting had towards we the of Geoff,

received there usually based bit to minutes. FDA just sufficient you we longer sharing it for clarity before our So, the What will little on a was reporting to had be exchange with a is take we I'm meeting and said. us what

Geoff Porges

Okay.

Peony Yu

Okay.

Geoff Porges

Great. Thanks.

Peony Yu

Thank you.

Operator

And question comes our Citi. next from from Beatty Joel

Your line is open.

Joel Beatty

New an a little editorial address X show there with just to at seems July a favorable, England hypokalemia a able of studies results about for There the with [indiscernible] The EU Hi. Yes. reservation. that the also Phase that Recently was finding if publication Thanks U.S. potential Journal Medicine you was generally hypokalemia? talked from said in that and X question. be that? taking And the and also, then, of the results Would discuss of there to Phase China. bit was patients from in seem end up?

Tom Neff

a editorial Joel, quite up the right so two New surprising. with is at and about month. work editorial So, point suggestion, safety articles The and board's for structure little there the for end here. a a so And came on, starting Journal aggressive, at it intensive was topic was discussion of their England these

explain we Peony. can it. see ahead Go Peony think how I

Peony Yu

Thanks, intensive. Tom. That was

an hypokalemia two as coming Journal, back in I investigators that year. or adverse apparent that to of by imbalance events reported So, previously reported last believe X it studies. was we was the after England around China Phase New ASN yes, hyperkalemia had discussed November And there in

analysis the lab for that no on two the supplement imbalance based in also that is report there when Journal showed England New data. we manuscripts Now, hyperkalemia, these central

asset consistent not the kidneys patient able blood and elevation potassium regulate a characteristic and levels as populations, background on is to patients, Phase into question. your base disease that larger reported of those balance. X CKD To potassium way are of properly has CKD further good is on level to program another address Just -- the that look questions a indeed because is been

suggests, values we of roxadustat. comparator the larger hyperkalemia medical Phase We results there roxadustat and reported upcoming analysis Also, the the of is from much and these in presenting with look events hyperkalemia potassium arms central and studies. from non-dialysis have longer between studies rates So, incidence to seen a of the risk adverse the also X comparable forward lab were what conferences. dialysis in use the

Joel Beatty

for the question. Thank you

Tom Neff

Thank you.

Operator

question from Yang Mizuho. next our from Difei comes And

is line Your open.

Difei Yang

Hi. question. for And thanks Good afternoon. taking my

On responsible you primarily us the the roxadustat or AstraZeneca NDA is would who's filing, submit is remind NDA, -- for to it FibroGen? it

Tom Neff

Difei, hello. I please. Peony is, address this will have

Peony Yu

Hi, Difei. you. Good to hear from

very good a partner the is AstraZeneca in U.S.

of for the FibroGen the after the terms responsible also putting responsibility and the roles And submitting file together In party IND-holder. is and to the are FDA. we final

partners. In terms collaborative ways frequent of a relationship as we And together, -- we of working both generating have with our the study results highly communication of well together. as have

Difei Yang

for Thank Okay. you the clarification.

would IPF, top-line Now recruiting have should when Phase us changing be subject to expecting remind for you results? X, you we started the

Tom Neff

Elias, please go ahead.

Elias Kouchakji

Yes.

possibly that between see and Elias. IPF you and is its as of last over time all enrolled have patients. to just When time early going late seen Difei, a have treatment, this this This in This take XXXX. XXX to data is a at study. the can study the and little [indiscernible] enrolling be -- one-year a to study of in end this studies. We enroll -- XXXX started bit As said little would patients across enroll have will the is we

Operator

Walsh comes from And question from our next Stifel. Adam

line open. Your is

Edwin Zhang

is our Congrats Edwin progress the taking on for made Zhang the Thanks This questions. for again Hi. in quarter. last Adam.

on few incident questions, a first have if may. I I is My dialysis. So, question

So, data, in the incident can on what commercial there? will based comment dialysis also label your approved. -- So, safety this and and expect and strategy over do defined the you patient population be non-dialysis. the filing if efficacy is [indiscernible] And similarly you listed

up there. Thank you. So, have And questions. a I follow strategy view what is your and

Tom Neff

can you incident Peony, address first. dialysis

Peony Yu

Okay. for Adam. Thank question you the

Tom Neff

is It Edwin. Not Adam.

Peony Yu

Yes. sorry. I'm Edwin. Oh, Yes.

as indication in the CKD terms and seeking approval -- we also for non-dialysis. are as in primary So, our patient our the indicate primary dialysis submission, anemia of treating

dialysis, -- subgroup also that believe of a do Now this and have that for important discussion part this very we supported. that reason incident we is which say is The our in dialysis.

with therapy during You our of follow have as drug treatment dialysis that, during this dialysis. time the anemia and starts to reviewer anemia is oftentimes around of as medical well course patients the we course the discussion initiation of the continue

do the now the information expect impact of and And on this information feel on we are to prescriber important have positive potentials. importance this given the of for commercial dialysis We physician. patients prescribing incident outcome to that

reviewer a medical FDA and additional that and review has as labelling Our suggested be will whether analysis far issue. as

Tom Neff

that The correct? was NDD, is about second question

Edwin Zhang

Yes.

Tom Neff

So, NDD? restate for Peony please full address NDD. your Can you question

Edwin Zhang

your, Similar the also, you placebo? to the are population. high and competition you commercial the in filing the incident maybe on set if because strategy? dialysis is And potential bar comment What a safety,

Tom Neff

Peony go ahead.

Peony Yu

Yes.

value are risk at in for we primary keep previously is of reduce considering So, drug had have risk. very also endpoint And the agreement very transfusion anemia when and to were whether benefit safety view on we the renal of primary are pleased cardiovascular progression medical level results because of the as attenuation only with pleased reported. with a our test of not a analysis well positive -- but NDD. from point view commercial point safety looking we up, of the as we blood therapy that hemoglobin efficacy and We

and ESA drug a drug our is safe that very as we and has as a safety side, because is that market. patients. a show be dialysis it do will also than and the partner which considered Now, we comparator an need AstraZeneca is to opportunity which to larger how the believe is to medical placebo And bar the -- demonstrate opportunity drug non-dialysis orally unmet market is safe the to administered, and give is placebo, will, placebo to will We both of beyond based it on the able we its have that a that fact that what ability or -- merit. own is on market our the -- expand makes accessible address as and we an it to believe the high

Tom Neff

Potential in than current larger is the market non-dialysis dialysis. [indiscernible]

will competitive you other think the we questions? on have aspects, to probably I any comment did decline

Operator

He has queue. left the

Edwin Zhang

Thank you.

Tom Neff

Go this ahead with next please. question

Operator

a from Danielle Brill from Piper question We Jaffray. have do

is up. line Your

Nirav Shelat

us everyone. taking Thank sure regarding you Nirav Would This had for earlier. not you you two, you're be able tell have I answered. you the currently data asked with questions. the question that that adjust to for outs? for my Hey, with and is Danielle. the it on this that where, statistical rates when if was was doing analysis absolute drop a just I'm

Tom Neff

be the able later won't process. discuss that until We in to

Nirav Shelat

see. I

Okay. should regarding amount geography if a are had And we other us I wondering with ex-U.S. give how the study. of the sites? many in Thank you I ongoing, ex-U.S. significant if States question patients And color of some United expect could you. enrollment was IPF the currently and versus the the to on the come was sites

Tom Neff

we are These and yet, now, explain. accomplished this targets ahead please go haven't so Elias

Elias Kouchakji

Sure. is majority and -- The globally. target as this similar is product, U.S. globally would is the from is be the which running other

number potential ex-U.S. have from large U.S. very are the time. going are We EU at of versus to number Southeast regions, from other the all and the come from the patients coming patients We who a and in US the still targeting same

that of sites number eager study. rolling seeing of and very to are good We part be our are as a this

Tom Neff

for that. you. Elias, Thank you, Thank

Nirav Shelat

it. that appreciate color. you Really for Thank

Tom Neff

Yes.

Operator

over answer the concludes final I'll turn call question for this remarks. Tom session. Neff now to back the And

Tom Neff

all various of and investigators, it's is of a We part physicians are recent our to potential and This say thank therapeutic the in medical Roxadustat their families cannot programs. community to gratifying see on hard the to to have need them. the testament advancement the and dedicated Pamrevlumab participating patients and expanding goal enough our the our for by by of publications the who work who as me Let of seen And patients options incredibly same We employees. results. their the of to of to clinical years recognition studies.

our followed ideas our to our in are and you born story development of Thank also advancement have shareholders, the and lab. seeing who research

like and good Thank afternoon you joining evening. everyone wish a I'd call. our to for

Operation

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

FibroGen (FGEN) 8 Aug 192019 Q2 Earnings call transcript