FGEN - Earnings call transcript Q1 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to the FibroGen Incorporated First Quarter 2018 Financial Results Conference Call. My name is Michelle and I'll be your operator for today's conference. At this time, all participants are in a listen-only mode.

As a reminder, this conference is being recorded.

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

Karen Bergman

Good our you. results and you of thank corporate Michelle, today. afternoon Today, joining XXXX. quarter first call for financial we for update thank the everyone are and reporting

today call Dr. Financial Peony Officer. Cotroneo, Officer, Vice Yu, the on Medical Porter, me are Neff, and Chief Seth Therapeutics, Chairman Fibrosis of Chief Officer Tom President Chief Executive and Dr. Pat Joining Mr.

up we with upcoming Following open a Vice of Elias Safety will our Drug prepared Q&A and then remarks, Kouchakji, and Development, key also today for milestones. call wrap And will be will Tom the objectives Senior we by Clinical Pharmacovigilance. discussion where President, joined Dr.

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

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

Tom Neff

us you, afternoon Thank Karen. everyone, us down get screw sorry Good Thank for today. started. the slowed up for to technical joining you the to

in and for in We organ have case. strong program I'd comments with two anemia significant few to on Pamrevlumab exciting first therapeutic indications each deep and And now Roxadustat provide treatment we fibrosis update in for and including of both solid clinical last-stage Roxadustat tumors. a drug candidates data a outlook multiple market with need brief additional for like a our programs quarter China. have

total few or final will and patient in have program in the clinical Our Roxadustat with US X sponsored be across our NDA targets meet our global X US increasingly in seven EU In submissions. the X,XXX by for that of in approaching jurisdictions next treat the to in with recently two these program anemia June we patients patients to month. XXXX board EU completion, studies AstraZeneca regulatory Roxadustat years. with starting enrolled the Phase over requirements, in five busy companies agreement of at the over and early global CKD four the team designed reached past with recruitment studies territories, Roxadustat preparation Phase the regulatory a completed the program, We with CKD approval

the four these placebo of dependent versus to top three and of and accruals before plan studies from number non-dialysis non-dialysis program complete of results FibroGen Japan, of in NDA as the and XXXX. dependent European study possible with This of our combine Roxadustat to Roxadustat studies CKD analysis and quickly pool to conducting for US, in the studies and expected with events pools MACE adjudication as expect last MACE requirements of Astellas requisite five In line the partner and We by Phase CKD. [indiscernible] AstraZeneca total prior for dialysis reach US results preparing mean to end report we the Astellas in a for report Japan To to studies relevant expect patient, XXXX. first year-end NDA. half fulfill X MACE visit filing the and studies. the the will is last is to We pooled and We adjudicated the results MACE dialysis plan September.

Japan four patients. X all dialysis in completed has Astellas Phase studies

FibroGen working on domestic be sites, by of inspection hemodialysis will partner of and process call. for inspections anemia analytical review new campaigns, review approval comprehensive for have core This NDA To studies will the registration last results the receive of China to XXXX. NDA Astellas In the Yu quarter product inspections. China approval Japan onsite online in on our drug of with name NDA in Peony receive to very with Beijing post a launch this expected China the treatment the Roxadustat Astellas studies China, clinical notably, The completed responsibility review non-dialysis of Japan the study complete approval commercial we our our out schedule the are regulatory X manufacturing innovative may readiness. been anemia China after to the conducting We and and in from recently of prepare in CKD and testing in in the first launch associated these we a team sites, to the dependent in for technical activities of FibroGen. FibroGen few, of China in for dialysis Most are this support China, We months this on with cover Roxadustat was year. the Roxadustat. building manufactured facilities program, top discuss readout fourth of come work facility capabilities two advanced Cangzhou the manufacturing than This for one a areas when drugs. phase Dr. the the two data production our their AstraZeneca two X associated with awarded broad reviewing later phase or later step expects in country for CKD was class have filing, October. manufacturing drug applications occurred especially In necessary and line pharmaceutical about drug a process commercial originally for of from PPP. FDA one planned. a patients dependent Cangzhou range NDA key was permit and is authorities earlier accepted substance by for recently trial API as

So, the team getting done. kudos to China for that

by as access value implementation in this Pamrevlumab We development a maximize term, yields we on or Pamrevlumab that on and a is to of we we statistically formularies are of a vendor focused in address the off our resources with in muscular program. experience, early diseases, expertise, X fibrotic in visitings And to medium also lead part term. phase working area our In fibrosis see market the the HRCT treatment by program, reimbursement of are on drug strategy closely and oncology the quantitative reduction hospital short substantial developed dystrophy. to potential to in with the and gaining national range the of In MEDQIA. work. with on China. the brings we as known of algorithms cancer advancing lists and trial Duchenne measured then the it, and Roxadustat With by regard Pamrevlumab of determine proposition very broad the IPF, with AstraZeneca the leading fiber followed reimbursement, IPF, AZ inclusion provincial using hospital as progression our fibrosis randomized going other significant inclusion our at look on pancreatic lung what's

we far study significant So is XX measuring as first lung report that fibrosis range. changes effect XX on the a this or and a of weeks full-year weeks meaning know, statistically

advanced an patients with function of of our prevent particularly that compared in with meaningful efficacious patients reported safety lung XXX with volume and absolute a of the the Notably, progression represent advance endpoint, endpoints. to-date characteristic for two in disease consistent these a progression positive of over In types and effects of have Additionally, decline well endpoint was our observed Pamrevlumab of progression our correlate and us patients. and and or secondary phase statistically been tolerated an adverse previous for with save this IPF death. and Pamrevlumab a these results study therapies with result showed reported the predicted disease percent in IPF patients. from both To-date, Pamrevlumab total, compared IPF XXX. slowing XXX for the life. in all we phase approved reactions disease indicate experience XX% pulmonary obtained trial believe was progression as combination safety would or or populations of to progression. of fibrosis CHRCT and in results safety to we controlled the measured studies. disease clinically significant in results studies. predicted appear results tolerability week and major recent phase by greater been open-label capacity have slowing Pamrevlumab improvement placebo in in patients. of in similar of the Pamrevlumab position FPC in suggests disease therapy has randomized with of IPF. similar to-date, mortality primary the composite and two improvement placebo XXX IPF as are to key population, progression study associated including placebo measures A treated trial to in Pamrevlumab with XX% In Apart our life as in changes assessment results reduction patients have nearly vital development by our percent phase defined the X and was side in retard development and endpoints the result, of the in quality and exposed on XX In therapy IPF, IPF an been freefall meaningful effect for that morbidity progression events good a predecessor patients In including with percent force may minimal disease current placebo not This Pamrevlumab quality XX.X% progression of well observed treatment proportion a X

lung in presenting program we we quantitative will results meaning we from expect will significant at our present Diego, X mid-year. study our the progression. by on San from forward, where on FDA showing be HRCT Going At phase HRCT our statistically the to reduction fibrosis XXX agency us obtain data coming feedback ATS study first

the Second, a past with of from lung clinical gemcitabine. clinical positive third, this fibrosis combination indicating In results the evaluating Respiratory Pamrevlumab pre-clinical our induced in which are quality therapy other In February, designation cancer the of fast predictive results population. improvement St. of has program, of LAPC pancreatic IPF Pamrevlumab advanced life. And using aspects track promising development in new in of pancreatic outcomes. potential for cancer unresectable on assessment patient we model in Questionnaire George highly be results granted and in to given proven locally or the as based radiation FDA

majority from as our pancreatic a in treatment. six resectable of In treated Pamrevlumab June. advanced at with annual assessed of and were after a X updated phase patients nutshell, meeting report chemotherapy open-label ASCO months results cancer trial locally unresectable these will will results We show ongoing

to will for We also study resection. the who in appears that survival a be patients report have there undergone tumor benefit

with trial Duchenne to non-ambulatory of patients. trial or a reach midyear. to open-label clinical muscular This agreement are clinical on X design announce pivotal we completed In muscular phase we the is focusing dystrophy. expect Duchenne pleased three-year We study have FDA non-ambulatory dystrophy by on DMD, enrollment in

mobility. the genetic ability gradually you is body XX know DMD gene, upper age patients the and walk to degenerative As lose by strength caused by dystrophin disease lose of a typically and mutation in

wheelchair of XX% bound. population over the fact DMD In is

programs. to mutation. dystrophin Seth development particular updates provide As not on Pamrevlumab is Porter a potential to be anti-fibrotic Pamrevlumab any limited activities therapy current would in here Dr. today our

the anemia Dr. the Yu over turn XX, March had On on million side, update to me further in as that, With Peony? let FibroGen $XXX.X financial now Peony program. this of for cash.

Peony Yu

Thank Tom. you,

on of requirements we in X mentioned, region in completing As four to registration US multiple in AstraZeneca phase and and studies are the China, the with collaboration agencies regulatory Astellas meet regulatory currently and with Europe Japan. Japan. covered will the our Tom progress and update review in Chinese focus by today where NDA in the has agency. Europe, China is My under US,

which EPO of program a Roxadustat and phase studies non-dialysis is Our in studies placebo. with in Roxadustat US three four is to which compared three compared dialysis EU consists

completing have we have non-dialysis have patients the we across the reach in than in four in X,XXX June, total more enrollment We with patients alignment will AstraZeneca already studies X,XXX enrolled three enrolled and dialysis studies. over

evaluation Safety Data safety since of DSMB NDA last Roxadustat based from in to Monitoring plan we phase X for our recent analyzed Primary planned we September, fourth has continue which DSMB studies is clinical this the phase XXXX adjudicated or in periodic phase separately the at have expect report MACE end dialysis conducting arm. MACE and be The Board March, prior to phase data the endpoint With received to first patient from protocols. these pools, X the non-dialysis studies throughput the these half for most results to X analysis. current of independent quarter on efficacy per year. two the with assessment program the in data this review of the the and studies of studies At recommendation as sufficient by been seven individual meeting, of .The will submission X treatment we

may non-inferior safety medical non-dialysis to for I our the for to our in opportunity Next, would patients. comparator US an this non-dialysis black in assessable in address box combination a is of ESA ESA therapy. there a large is generally decision placebo a and patients label. to and evaluation, to using considered standard program Roxadustat inconvenience ESA on due finish. to label CKD comparison. a restrictions, the orally demonstrate as the EU US, to be left concerns, avoid like safety option is anemia in gold briefly Placebo safety about In our highlight If access trials important be which more Roxadustat to need attractive untreated Therefore, may of therapeutic limited unmet administrated offer anemia to placebo

of Roxadustat to discuss a total over studies. six Turning phase Japan, are there X

Our studies comprise of in with studies. These package associated patients for phase dependent partner, the targeted for the data is completion needed X NDA Astellas, and has the Japan will four for submission all in anemia dialysis announced dialysis this CKD the study pipeline be will be were will the XXXX. This followed both X after by non-dialysis dialysis in indication peritoneal phase will be submitted NDA disclosed the studies non-dialysis for of Japan XXXX. November of in The results which completed. of

XX. hemodialysis times a who topline received Astellas week both a were per per in by baseline response by XX.X% weeks. increase least deciliter the defined three deciliter. achieved achieving followed three is milligrams, of in In planned three to study dose studies, they XX.X% The Roxadustat This with one Safety from study, studies fourth phase grams XXXX. two XX are XX in with hemoglobin weeks higher, shows for the titration hemodialysis results was previously The recently second dose, an patients. milligrams conversion gram consistent data study prior announced XX.X% in patients from Japan this study to positive in detected. hemodialysis times and hemoglobin no XX at those Japan the hemoglobin of phase patients both at hemoglobin consists readout X of ESA, dialysis study XX-week as results for weeks ESA-naïve patients was quarter correction who controlled XX.X% in XX dialysis active dose XX or in Roxadustat treated In these already with safety to switched completed week the is is at study response. treated patients. plus received incident and signals XX-XX XX hemoglobin treatment with primarily were patients Roxadustat. studies and deciliter per then an starting starting grams between and ten maintained the findings patients

CKD studies to call with phase forward authorizations seeking become continue therapeutic the phase multiple to months. fourth completing patients to for they back the non-dialysis Tom. Japan will data toward like collaboration In two and in enrollment look we you colleagues, the China, studies regions Astellas has studies in tuned. AstraZeneca efforts XXXX. offer to X We completed anemia and reporting coming available. marketing to results in summary, quarter CKD various in of regulatory US, of Europe a of now new the We submission planned as be support our already readouts X rest turn these of One with to patients shall option world. Stay to Japan, the in I'd

Tom Neff

status Porter Dr. Seth? will and platform the indications. our therapeutics of Peony. you, Seth lead product discuss now corresponding Thank Pamrevlumab

Seth Porter

presented accepted SGRQ, Thank thought fibrosis consistent quantifying to IPF a blind Pamrevlumab well PKPD IPF compared phase in placebo In fibrosis. IPF, up Tom. clinical our date of respect for our study. and Respiratory clinical for Diego. XXXX control with include to of of or radiation published analysis X consistent The XX. These Pamrevlumab with the significant broadly using is used clinical FibroGen assessment trial May SGRQ scores can from of modeling and results and poster is model placebo and instrument changes poster scores treatment mouse HRCT, fibrosis for or positive With we results quantitative to will model published and HRCT measures patients, changes of on fibrosis in expression the mitigate placebo methods May that progression FTC be ongoing in systemic related in are related gene statistically IPF been associated by most on life expected XX. presented to George results fibrosis meeting for patients. St. SGRQ improved quality reduction That SGRQ from of Patients in from The last showing by open-label poster abstracts changes. from poster assessment in in updated presentation radiation lung effectively Pamrevlumab be IPF presented be with the be preclinical assessment treated induced with PK you, presented induced previously Four the spectrum that the results Monday to have Questionnaire ATS data to demonstrated results life the show leaders. had HRCT, the lung worsening disease. by an patterns quality The These patients of will been at Sunday health expression randomized received be fibrosis to Pamrevlumab tended expands a Sunday the studies. treated associated lung upon progressive many HRCT continues results quantitative will those with gene upcoming has in that double San fibrosis The health XX. on while year May of lung as extended reverse

in and clinical efficacy Pamrevlumab fibrosis are from study phase positive Our of to to has leaves further progression, outcomes human with grown a and of pulmonary disease in clinical position of combined in us studies. development believe the IPF X our understanding safety strong That, IPF. potential XXX we animal including from Pamrevlumab

Turning Tom received pancreatic advanced have cancer, of to unresectable from the for as fast very we to the are track FDA Pamrevlumab cancer. treatment designation for pancreatic pleased mentioned, locally

adjuvant no has this for results for unresectable surgeons drug recognition of which cancer yields pancreatic and updated that oncologist be indication among general in is locally for advanced is Consequently, from Neoadjuvant a the periods cancer treatment approach for There been globally to or locally study XXX pancreatic successful interest cancer. approved. at resection phase survival growing combination drug June. there the X treating benefit. new pancreatic an ASCO will We is advanced meeting treatment reporting

design quarterly to to trial in preparing with expect FDA and meet the feedback have next call. pivotal We the are

benefit status prevalence Tom males lack sometime turning after XX,XXX completed of to after may transition associated one limited non-ambulatory muscle and is accumulation status an a fibrosis population. Thank mentioned, clinical to the multiple muscular patient the mobility, expect and the evaluating wheelchair with mutation. study the of trial trial, upper for our that XX% strength pulmonary a DMD the of age over action to Duchenne focused Finally, normal Tom. wheelchair The in dystrophy, to all muscular DMD time call muscles is we in transition In to is not and the is patients endpoints. more CDC, today, broad dystrophin your are US endpoints leads we to of on sometime will Thus, body to DMD extent a phase patients. X of enrollment function, function. to mechanism Nearly anti-fibrotic as the This we dystrophy turn of Pamrevlumab fibrosis loss than of and non-ambulatory a three-year dystrophin DMD. in The including ten. imaging I of age of back According Pamrevlumab ten. and the approximately and patients non-ambulatory particular you

Tom Neff

Chief through Seth. XXXX you, our us Thank Pat highlights Financial of for the financial Officer will Cotroneo, now Pat? walk first quarter

Pat Cotroneo

Thank results. you, before I Tom. discuss comment Quick

on previous January with standards XXXX. the years AstraZeneca and from of have of current AFC-XXX. if collaboration indicated, accounting this X, the Astellas results our all recast start been had the standard agreements; financial and company since Unless since titled a since we XXXX, XXXX contracts as basis of periods adopted fully otherwise known as revenues update also As XXXX-XX adopted customers retrospective the

our note information of more on quarterly one today. of SEC on For Form the report XX-Q filed our please with earlier revenue see adoption this guidance new

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

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

compensation totaling million sheet under portion $X.X consolidated of from cumulative our an guidance a million through the adoption the new stock-based $XX.X operations will revenue reported. noncash over was January balance previously recognized aggregate resulted recast Upon expense. the AFC-XXX remaining for revenue a of and of of XXXX, As future of in of X, as the result million compared we each to amounts in net the $X.X which in XXXX reduction be of development period. quarter XXXX million first and a year-end revenues This increase $XX.X statement

As we at XX, million of XXXX, the $XXX.X to $XXX.X as March had compared of cash XXXX. end million in

these cash For building purposes, and restricted grade debt total equivalents, corporate investments, deposits cash to consisting refers to receivables, time cash, cash, relating including lease. of investment primarily our

a currently over would to million, I milestone are We to excluding the like to the received with may you, of Tom. back our be under collaboration payments million And projecting Thank AstraZeneca Astellas. yearend and in that everyone. turn balance range agreements cash $XXX call $XXX

Tom Neff

Thank an you, to Pamrevlumab. exciting Pat. year looks be XXXX and for Roxadustat and defining both

the FibroGen and AstraZeneca. in enrolment run report Roxadustat by of patient end studies China, We Roxadustat phase we anticipate five will a market the from in top to quarter the with along of approval AstraZeneca by decision US results conclude studies XXXX, clinical In CKD, X Roxadustat, X For in quarter year anemia second for plan fourth line phase XXXX. in XXXX.

measured progression therapy fibrosis, be IPF, will of significant have we HRCT. benefits as seen Pamrevlumab results For Pamrevlumab quantitative and ATS. other These and in presented from this month by at statistically

for Phase pancreatic annual results call. program in Phase meeting the ASCO the trial pancreatic Pamrevlumab report in in X at cancer locally on updated will advanced In we our X We quarterly and cancer, June. expect resectable next report to

to registration cancer. over advanced that, pancreatic I agreement expect pivotal resectable with Karen? Karen to the trial locally on for FDA back call We design reach supporting to With pathway clinical like and would Q&A. a mid-year, for turn

Karen Bergman

you Tom. if you, lines for the Thank Michelle, kindly up open questions.

Operator

question ma'am Beatty First comes in with queue Citi. the from Joel Instructions] [Operator

Joel Beatty

there Could realize goal regarding wiggle of a what MACE boundary X much a to program. phase the give is how if is of room non-inferiority? sense events the in one you that the first The non-inferiority or is, roxadustat for

Peony Yu

question. So, Joel, for thanks the

refresh non-dialysis I So placebo using - one use studies just the we are analyze looking that as at we're so - the the to control ones - we now are - ourselves, mentioned.

so the the And now until will studies non-inferiority. that need demonstrate wait the - are studies three make blinded, adjudicated to over of XXXX the to and so unblinding we and from show MACE non to - we patients. - across will the comparison And to still

from and we grouped will be with then and pulling in epo the studies into So, be treatment comparators similarly, across will and the four will dialysis, be one arm roxadustat compared then these succeed in we and will and superiority studies. if And then do the that, move we be first non-inferiority that, succeed once will in - when then we for comparison. path

So that I Joel. question, answers your hope

Operator

The Michael comes from with Yee Jefferies. question next

Michael Yee

Roxa question and a follow up.

your once? out there the bit couple can than whether put just that was the On is it and line why the understand a to talk little a the press it Maybe question, base that, about analysis, last months at just following case MACE and along out driving to non-inferiority opposed how in the right top waiting about rather for one all you release? And all in you're efficacy MACE of with talk full not it guys release expanding non-inferiority is, data superiority as or what all related you handicap with the to to direction versus everybody specifically then putting for want roxa. we going just

Tom Neff

Michael, the quite last you question. say follow time? second Could that I didn't it more one phrase in

Michael Yee

Thank in drug on all years lower non-inferiority I for. a and you. trend types would to the case events event versus not the is ago arm and base accounted with treat rate MACE favoring or the whether understand ten been it whether like of that is the has just patients today

Tom Neff

Okay.

get accrual have we to the and meat was fourth report to So What let me quarter. studies this ourselves to Peony, would take you're do to thing. a safety with wrong of of in delay and pools. It regard will say the do the part be the the is there AstraZeneca to out then going five first that

studies, those under running differs AstraZeneca for in what and now Europe little of bit didn't then to part reporting quarter not are of the these - we're that which fourth add we and the Europe the done a is So from set studies, Astellas in rules studies these obviously, US. the have in to is we doing a

and get think done, for in that for amount will their various for for a deep a some on of time goals two lots saying into of MACE officially, account that signed agreed up the be usually fair calendar with time this line we're everybody and top properly thing off March, partners to so incentivized It order while things December, and to it goes would our have be reporting takes that to we to around in saying but not people are provide easy, so we're set also the organizations little extra mid-year have take And to and say it off. turned that. we if sign to is because the to on. We by

fourth study effect, So dialysis report time at and in December the out working take, in how take hard any that adding XX. and in or it's periods much issue then at the time, of any studies not non-dialysis these organizations in whether you've the study time pooled just point it's after might But third integrating the MACE submit NDA as point to got be things. that challenges it three that there'll those tell in and on that

Peony and and go of rest there it please. answer ahead the the address that's So

Peony Yu

Okay.

it adjudication add takes one more one adjudicated has small external the independent party it reason the longer I to were data to steps, supplement, because operationally a send novel independent what saying a the experts. few more also about to like Tom, to the needs data, point would to you So by obtain is

Tom Neff

Yeah.

that actually. about right You're

have We step the add the in to calculus. adjudication

Peony Yu

the when as soon as clear Exactly. report efficacy from it complete whereas the study the is And we and result we study, out data, we analyze the can it.

we spend. save So that

so And delaying result, different we top line is you time. at instead reporting why of the to this a do

seen CKD. not your the patient The I is have difference of for population trials. and our we approval patients are of the us supported have control part and second previous the changed. less change the in XXXX, ESA ESA, Indeed, question, have security - since hemoglobin had the advanced are the CKD on that what's in of standard on they not however patient you So higher a studies entry patient studying criteria excellent an treatment of dialysis publication And that between any not label the the treat asked have question.

to needs And So event, study, patients - studies baseline hemoglobin than would be the patients as a so MACE in far. now, the what tend rate more as the typically hospitalization. EGFR risk advanced reported to higher together, tend our those of disease patients placebo what And as been it's reported mix far overall implication has XX. our and the the kidney is study, we a with such overall, than right But that have in below the event to lower or been have treated blinded lower be Roxadustat right, have mortality when treat. chronic by up observed they that

Tom Neff

you let me interesting an So - it's Michael. asked, question

placebo, study, of at patients around versus study this type that In treat thing population other they here. non-dialysis treatment sense. the that a make before, me Let any no the been EGFR median looked study of had there's one at range. XX a there's would comparative In XX, so never add

and is between this Xb X. stage So

versus more disease our substantially at looking are study We in in placebo. non-dialysis patients the advanced

will mid we seeing expectation. in So teens EGFRs my low be the to median is

enrolling medical that and this rigid lot attaches the make not dialysis therapy people available any for the to pool really that it And notion of so have any the there's at also practices a of countries that notion doesn't decided sense. in rule this EGFRXX and

of and all XX so on. and the seeing EGFR we're US countries EUX routinely this profound X between the in in number so that patients are and And

EPO no in whom simply the bundle, with all whatever large very therapy. there's for at just treat of evolved the those therefore hypo a bit well, has portion, of the world a patients it handled in since, the have work there right patients system the the under the dialysis impact well quite cannot inflammation has frequent And inflammation the and not still in the it study. and reason, on since event the so, US now that the less are We rates in out patients put, longer. and roxa true and are a takes but And response of about third for number is the issue

inflammation no that epo these while that view sails so the completely impediment an segment current through an will population, idea of unmet So from CMS, if as and there from given fails, roxa things as they we've the was heard now, need medical therapies.

And various want these so you as might you're to thinking consider in I picture. about overall think ideas, these the points

Elias Kouchakji

the Elias pulling like different for done efficacy event. this by as in which a in of That's as - itself lead end everyone, safety remind was able been non-dialysis. later the MACE trials now what's make to that, the hemoglobin is which taking XX.X, MACE's either add That treat by suppose does complete that targeted treat treat to than multiple difference in this to would analysis, is hemoglobin endpoint. is I this different we studies number our we to is itself. a itself point a then I itself and MACE data, just beneficial, profile the Again, the clinical are be is is for could to MACE big of is while Tom, in why on study time all when studies, pull So

big a things differentiation have plan two treat do. between in to our we to as way these the a So versus programs

Tom Neff

conclusions. at on the copying there Let know, no incident non-dialysis as me sufficient of to arrive know, are dialysis being in technology, no placebo that are roxa also Michael the are out far studies at as as point and be manner I I amongst a companies that far that collections would as other all there

that's so And distinction.

Michael Yee

there to to so high give was some are you're treating and interesting It is color. things not appreciate charge it. treat, level because the very about think the rate yet low, Appreciate as

Operator

the The Goldman Sachs. from Flynn queue question with next comes Terence in

Unidentified Analyst

This is of background on expect of any their can standard a on recently actually we phase on design Gavin more that care. on provide mid-year, design. question competitor for X design color on Pamrevlumab know a Terence. Had shared you I should that quick the

So I the we're was in it going just in wondering a DMD commentary on that and term study. then not whether get to or

Tom Neff

with So let me question. start the

the mid-year, - to this you or part are referring pancreatic cancer IPF? For of

Unidentified Analyst

IPF study. the Apologize,

Tom Neff

Okay.

where from the very comment is been So I like us our has Elias, innovation on this data this following beginning. general we idea to please. takes us, are if mean for and you'd

Elias Kouchakji

the remind complete talking the have is significant it overall to has everyone like phase about you add would the while of top is which this X little in is the much is we X population our that that this I that X and results. at least, XXX, this power they on of a level of this design you're this has what and this is time, That is of data very At - by and planned us to this be be. potentially data product company, different we given have understanding studies, studies, will Yes. been - based design in that their what consistent phase to taking It's data, itself on the direction does a not with when previously. statistical certainly our and appropriately has in will showed on minimal studies,

trying three is study it population. enrolling to for we run we this DMD be the that non-ambulatory, facing we and using other this study understand be complete good So, at as up This a able the of in well to are product will be less this are that most taking years. very versus enrollment in this would will open occurring the feeling See, time hurdle regulatory is to the question, as discussion agencies direction lot be the data. with to

hope take We a look interim will patient that year treatment of some our when will and year. complete not to first the occur analysis till a next in to

doing is time. as data. three So this at the and so same that points Seth a From pulmonary this imaging the muscle function that look mentioned time, cumulative we a where take before, function, we are

Tom Neff

were Gavin, you with what question. your for this is looking

Unidentified Analyst

Yeah.

Operator

question from Leerink. next Geoffrey the queue comes in Porges with The

Geoffrey Porges

related is question My timing specifically. to

First on the you bit little may it though compared timing of about the past a less sounds to China year the confident this be approval, the as certainly. approval

route perhaps first may very for sooner same, opposed as end language confident be was year. approved to come Your where it it than even of we language in seemed country the the the could but that past, the roxadustat the

timing mentioned haven't Secondly call. trial So the update timing? your this be in it might we'll when even you say has a that and something something on that when where there design or Is of pivotal you mid-year And on terms look in what is progress for of like? IPF, what that providing you then too potentially will indication? thirdly, us could understand on And us you changed but soon to looks commented MDS give for roxadustat give in Could outlook pivotal Pamrevlumab MDS. an we like? will the a sense you still it and know trial that

Tom Neff

Okay.

make first. We've few one so what FDA that a And in the do in had we pancreatic parallel last and try So IPF. programs weeks cancer interactions apart. is to it are

Xth July. them so in be And other one the the early of be right will around one June of and will

pretty good given now. after these right know where the we of totality what comprehension We of to meetings, are we expect have

to very that would to earnings license approved couple in the what and us comment on. China, an are effective time - have be getting follow-on share Timing looking relates can approval therefore drug by China, done. been call. is we will so be number substantial of presume some right, China it assumptions presumptuous So it going large to The we're because to we approved things we've we it of August. next me to out China, get in we there or have in to any and in In as baseline have the early The length about that so of are reforms nature we decide the a first that wise, the to in have has circumstances say moved timing under of first, that's if think to it we China, is approve the time manufacturing years, as which of talking I don't of program. past about relates

senior programs they're now that how about a China I people with right this stuff. to issue think innovative in treat is going live in the decisions that make literally

China. have the are typical the are an is are that baseline small Europe, anemia whatever safety China because Everywhere cancer chronic US subset and alternative of a we people so it that would from which because you it sort the all China, of froze countries, all how needs indicated closely stuff not. not initially is instead reasons, And up but EPO, the China's And as anemia, ones or is transfusion, therapy in the epo in knockoffs unlike ones we we development else other challenges the care happened, get ended of transfusion. in products. really it such, The sponsorship they that for world, have when the very of believe it using uses that very watching China And in are in strong brand are of is goes. be in sense

approvals there's much nothing so, in epo. And the way with of

on. terribly and Evaluation's So very, To there timing going. excited that to are there's project China, a the lot gotten very example, no dynamically Anyway, relates materially to like Drug the overall. around deal time, doubt very licensure. large and decision need is we as moving with not date of this we've Things manufacture had things two for has a for. downstream changing the really whilst so commercial that invoices so things are year but and the point or People for that about affected haven't the drug Center are all obviously of on it that's

We November of lot good down some a in place China think and we were in we was sampled for December, is November per is and day momentum. videography really WeChat. and XX a few about So that. had to there on I - December XX look of WeChat for a to it days in

Peony Yu

and should to are class follow China - NDA, the and for first us we in follow of China, I always X.X, we we the you things Tom well. you as not laws is evaluated tell just us, really the And told China, presumptuous. and moving be being need rules as in candidate process mean

Geoffrey Porges

MDS?

Tom Neff

say was about asked had Geoff other question to going that was I MDS. the

go So Peony, why you don't and? ahead

Peony Yu

Yeah.

So, thank you.

a team fact, working beyond need, our where working through on Phase non-transfusion study teams we unmet we who patients MDS the who study are address teams and about parallel US transfusion activities of medical China job MDS in indication is So this study. we and and And dependent, opportunity have X/X MDS is but additional the is a MDS started to doing sites patients are dependent team at in on number patients. virtual global are in study first a have good anemia anemic. are start-up on two Both One excited is the CKD. working the very screening on are a

So are you provide in the coming months, we update. forward more looking to

Operator

William in comes queue Blair. question next the with Hsieh from The Andy

Andy Hsieh

Just from a timing Tom. perspective,

So long in in think China, a it would China? that, be after a was approval, how after how take recognizing revenues really the to get the So approved? sense and you it will long want question, of just start commercially available do I reimbursement drug just modeling to company when get can

Tom Neff

question understand make long sure say be right. your available? will me how drug let Did you the first I So

Andy Hsieh

basically for the and time would - take How it Sorry. commercial lag between the availability? long approval

Tom Neff

Okay.

distinct hospital and getting to a when you're and China, China So countries in you in China first a reimbursed for other from obtain that very and listing. business doing jurisdictions way have in China differs

to AstraZeneca hospital. And And find so used this, for manage listings. the BRILINTA per when time anywhere is to hospital itself cycle way hospital to listing X from launched China process we a XX months in of milestones by they

populates to XX% commerce get done the recent most major sought we goals of XX% in And the It I into the was we effort of think got about it's move that that than would number absolute before to first from of that necessity years, what so briefing the the I hospitals believe couple in conceptually, listings. China selling. commercial in the you side of as BRILINTA terms because are for being larger are

expects kinds those years and this three and provincial China experience and been four everybody substantial for I as hospital take so, the do And to process. going then where totality will what to point you're this we then has to side of auction traction in through the you the institutional what the It the get have China, where in about is first face you think that, with or selling of products. start listed after

hospital. to basic the XA addition in In hospital, however

sales, distribution premium We the EPOs now, the pharmacy as a direct to to domestic people there considerably prefer picture, they're the pay instance, have have out privately direct right over other that higher aspects, for willing EPO sales and price. is of part would to

these road. are countries. take files, distribution large in ones those So regulatory that on because several start in be addressable can that segments China are will addition, There market that it will the are on countries such

piece we're theatre where AstraZeneca made picture. much And so, that's appropriate. we as activities, to saying, you as in going of And the endorse has as it's look OBOR point the a another at countries can of

parts group know of are that I India, that think we China, China Macau as Malaysia, of and are but considered Kong not, way all Indonesia, amongst the countries in think Hong so that that does as the China some well Philippines, of as also. are

you'd experience based and a drugs China they've milestone so they So achievement, to on how several thinking the pictures in be to there's sort they've templates had kind time deal of a thing. are time are in US that have AZ very different that about of great than rollout, lot because but launched of a of

decision that after during collection. others period approved The where over, you a about we from trying which think segment we so collection, portion it in, you're made safety prevents the special dealt you're of a exclusivity, under what's is once all inside safety that the you is years four early patient will that, get in of with administrative inherently. under during but of have do rules collection to efficacy I then take that get way unconditional XXXX the that so safety And administrative or on that a follow is the compete is of And and and only and grant sense. get period makes to is sort called three do it exclusivity, that

really exclusivity succeed to typically about is you represent China. in but to the that entry in for hurdles, come, five years up these So it, as denominated we it's trying high compete period immediate over anyone A, the and be invest to things think to barriers administrative they getting not and so sales going as

so of I of that's this it where is other the and I side we helpful. are think as right So sort that's now hope

Operator

the no this questions time. at further in There are queue

So Mr. the Neff over I'll turn for remarks. call to closing

Tom Neff

data sharing We the the insights XXXX. joining and on today. during you XXXX call the for additional Thank all anticipate regulatory into remainder of clinical process

and June visiting We they'll work. seeing Annual on Los York Annual live Jefferies that's anyone Healthcare two X Conference to I available their feed, Sachs XXXX in to the see of to the upcoming the Goldman would it will And FibroGen Rancho States Healthcare like live. also and you those Global for United be in would in webcasting X forward a conferences, XX the Verdes. has Conference participating Palos Angeles and to to New video teams my Goldman got hard the China sincere so be conferences online, express conferences. can thanks course, dedication look June in We and in XX in

good Goldman support, last the an have the look in amount we Sachs to XX accomplished enormous gratitude and to months afternoon at our the to even seeing next wish you their as our and do a we for Thank and pursue have our my We And to everyone good Jefferies Conference. XX I'd months. partners the like forward investors Conference, you. programs. We evening. more

Operator

for you today's Thank Thank concludes you. teleconference. Ladies participating. and gentlemen, this

may disconnect. now You

FibroGen (FGEN) 9 May 182018 Q1 Earnings call transcript