FGEN - Earnings call transcript Q1 2020

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Operator

Welcome to the FibroGen First Quarter 2020 Financial Results. At this time, all participants’ lines are in a listen-only mode. After the speakers ‘presentation, there will be a question and answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

to conference like speaker to now Mr. today, would hand over the your I Tung. Michael sir. ahead, go Please

Michael Tung

Thank you, FibroGen's good on first operator, and of today's joining you quarter call us for to discuss XXXX. results the afternoon, for everyone. Thank

of Operations; Conterno, Senior Chung, be will Development, Officer. Pat President our Clinical by Peony Senior Enrique joined Vice Medical Chief China Chief Yu, Executive Vice Today's call Financial our and by Dr. Officer; Safety our our Pharmacovigilance; will our Dr. led Cotroneo, President Elias Officer. Enrique Kouchakji, be Ms. Drug of Chris Mr. Chief

Before design, regarding and other we of related operations, would our conduct and point guidance, matters. AstraZeneca to statements activities, results, regulatory clinical research our we our our including financial certain development risks results out with results collaborations that begin, I business, of and commercial and business forward-looking enrollment, may trials, initiation, make and Astellas, business like potential regulatory results our strategies to the and

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

result of forward-looking any or update whether new otherwise. to a development obligation as no undertake We information, future statement,

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

call the our like to Enrique? I now, over turn CEO. Conterno, to And would Enrique

Enrique Conterno

call. And to everyone, you, earnings and good XXXX quarter Thank welcome Mike. afternoon, our first

the to potential, for to presented I patients, treatment a and moment of to the bring like patients medicine pandemic, of of to FibroGen chronic investigators, healthcare on stakeholders providers, commitment COVID-XX first-in-class Given our would reassure and life-threatening challenges continued a the by take behalf conditions.

and possible. workforce businesses, many times. to Like businesses, taken general, society the In of to in a actions working and Governments, our the taken are these in number have has mitigate communities when challenging employees outbreak. both the unprecedented remotely our of FibroGen support spread COVID-XX measures U.S.,

China, in field. manufacturing now in working are offices, back While they our plants, the and

We need have implemented any employees illness the who of protocols facilities. to our work minimize to for our of risk on-site at globally

remain circumstances, in transformational a therapy, patients committed demonstrated Despite medicine we chronic in with of regulatory first commercial oral to and success potentially roxadustat, ensuring disease. the difficult the kidney anemia

With or the or improves. Pamrevlumab, IPF, indications the Muscular development situation Duchenne of we Dystrophy are cancer and idiopathic or LAPC, pancreatic three implementing a across fibrosis advanced unresectable DMD, comprehensive plan locally COVID-XX to with once pulmonary accelerate

factor or hypoxia-inducible and factor CTGF to Finally, or HIF platforms. our we tissue the advance continue connective of innovation growth

to plans continuity stated the are our goals. to we achieve COVID-XX, times confident that remain from and in are business Our and operations FibroGen our effect seeing resulting an resources impact we capabilities uncertain through and has these navigate

our manufacturing operations As there. China launch online, back comes and we efforts continuing are

launches supply as the support drug clinical roxadustat indications, Pamrevlumab and in both to We additional as clinical trials. have the ample well trials

your know closely. with and who To our situation families. to you are our with continue thought clinicians, will employees to patients monitor leaders, and the interact and others please regulators, and We the countless FibroGen, thoughts

with let Roxadustat. Now begin me

file quarter, FDA the and FDA the with interaction the continues. on by During accepted the first submission was NDA our roxadustat

XX, XXXX. December We date expect action by of PDUFA the

of this Application possible. In novel, the and make as in available and of in preparation as first-in-class patients second for medicine in is working the quickly anemia to quarter to worldwide many partners diligently for Marketing expected We Europe, with patients the filing CKD dialysis Authorization non-dialysis-dependent XXXX. treatment both our roxadustat are as

to Turning China.

As in focus and hospital widely A the National listing List that roxadustat the been know, be, roxadustat expanding the continues into has can prescribed. NRDL, be Drug included was you in was Reimbursement beginning approved of first or at went which to and year. China so effect key

late momentum the restrictions, March. in listings January in a start new the which hospital COVID-XX January from before We positive of late saw to in listings caused slowdown

today, return continue we here by new normal there. stand the encouraged steady in we seen we opportunity to to be and a a have As China roxadustat

disruption COVID-XX pandemic, trials the agencies however, conducts globe trials EMA regulatory and clinical guidance still for in issued FDA, causing and the clinical have during pandemic. the is across The the of other

regulatory incorporating recommendations these appropriate clinical as are We our trials. or closed

patients the Our our first FibroGen studies. ensuring priority safety participating and the at well-being in of is

details we seen to to impact each specific on the not on across can do of have all for our that we provide the say impact varying of – COVID-XX we While intend degrees. trials, an of one COVID trials our

focused continue trial ZEPHYRUS IPF for the trial, had a the on who providing already at The rest is albeit, pamrevlumab's where for enrollment, slower enrollment effective enrolled. we of trials And safety our pause patients. near-term most patients rate. continual of are decided Our to been currently care

be XXXX, have the protocol enrollments. expansion we amendment, clinical geographic In to the to plan, to are we includes activations, that best To comprehensive development accelerating such accelerate which of new developed that return once a and normal, site we committed can end, position in expanding things pamrevlumab. a and

unresectable continues cancer study to locally-advanced enroll. pancreatic Our

X, of for Dystrophy Phase Duchenne our is the IPF program our to preparations second study ZEPHYRUS III and Phase in Muscular in continue the second III We begin year. slated half

biology continue pamrevlumab in factor to in growth pipeline be approved leveraging and advancing and focused U.S., to our factor novel connective In expand summary, both candidates. COVID-XX, finally, getting our on despite tissue of we the development roxadustat expertise hypoxia-inducible drug

you to in-depth provide of will over more discussion will Peony, with who turn roxadustat. a Now, I it

Peony Yu

you, Enrique, and afternoon, Thank good everyone.

roxadustat Our thus far been highlights busy. would this has like of start some to today, year. the XXXX I And review

continue we our on PDUFA earlier, by to date XXXX. mentioned Enrique an of FDA the expect decision roxadustat December NDA XX, As

indication is have case, FDA no prepare diligently will in Committee scheduled. one to but an hold continue Meeting, Advisory the we We

ensure study in over manuscripts success months. submit publication the and U.S., To to safety We we partner pool our commercialization and preparations. individual continue efficacy coming for Phase the plan III AstraZeneca our and

Authorization Application XXXX. for quarter patients In and for treatment of in of the both Europe, CKD roxadustat Marketing second the expected in non-dialysis-dependent dialysis anemia filing is

continues roxadustat for dialysis-dependent brand for treatment launch our Japan, commercial partner, anemia in the of Japan In Astellas, Evrenzo, patients. of the name

anemia patients NDA under for ‘supplemental is Astellas review in non-dialysis currently by PMDA.

Spring presented roxadustat Phase Clinical We from new National analyses Meeting. III annual at the recently Kidney our Foundation trials

a And Roxadustat status conclusions patients, in following: treatment as our resulted of at transfusion did in can red hemoglobin significant to correction the ESA regardless reduction pool non-dialysis achieved roxadustat have qualify of patient summarized blood doses not replete sufficient baseline. treatment. In were this iron XX% iron with iron be XX%. of statistically comparable cell stores risk or the not in patients non-dialysis even for similar

of of to transfusion iron placebo risk the compared reduced and regardless non-dialysis rescue, iron roxadustat patients, CKD status in cell IV at baseline. blood red Furthermore,

transfusion dialysis red blood the versus of cell alfa. epoetin roxadustat patients Finally, significantly in risk reduced

hemoglobin transfusion analysis, the me hemoglobin superior are reduction and compared our particularly. hand-in-hand out Roxadustat’s transfusion accompanied endpoint superior EPO. efficacy roxadustat's Let primary cardiovascular achieved favorable to change by point of goes with safety reduction in results, risk

relevant therapy is patient the epoetin highly had of twelve risk pool, In months U.S. alfa. patients initiation and than This dialysis. roxadustat of the X,XXX incident in MACE lower risk ESA dialysis prior dialysis have of as the of received MACE+ XX% to a lower now XX% XX%

profile Collectively, confidence these results roxadustat may for patients. dialysis-dependent that give a differentiated us have product

is standard-of-care broadly. for for the become roxadustat vision to anemia our CKD, Beyond

the We anemia syndrome for continue with or Anemia MDS associated CIA. treatment Chemotherapy-Induced development myelodysplastic of roxadustat or and of

treatment of roxadustat We associated also anemia to continue additional with evaluate diseases. for the

study Phase randomized the roxadustat from our Hematology American of now for the this MDS, study the in XXXX of global treatment and with study. at conducting anemia we Society double-blind results positive placebo-controlled of evaluating portion Starting of portion are presented open-label III

this is reminder, of who of As in achieved transfusion-dependent patients to and portion independence. transfusion X study randomization XXX the approximately percent will a the patients X measure efficacy a second enroll MDS primary

hematology/oncology we study have unmet in also which ongoing an an II to space, open-label continues Phase in be CIA, the medical Staying need.

COVID-XX We options and commitment will continue patient safety manage thank of our to as their with treatment all top monitor, We priority. impacts developing the assess new for patients. for and investigators partnership our in

have Marketing Application Mexico, Authorization our in anemia of CKD number submitted and for Canada, collaboration Australia, countries, Finally, in been South Korea. including Brazil, a AstraZeneca, Taiwan partner, roxadustat with

for discuss roxadustat call like I to over the to recent would Chris the now China. in developments Chung, who will turn

Chris Chung

made progress launch am during China. the first I in to excited Peony. of you, details quarter share positive the on roxadustat the Thank

in Xst of accelerated last you Drug is of January As XXXX on National this and completed the is November. many included government that was rollout year an Reimbursement the know, basis. effective It ensuring roxadustat became List

been AstraZeneca-dedicated team. the the roxadustat have sales visitings of of focus a large Hospital priority our efforts top key and

We now to-date. available are pleased with listed our many within hospitals and is target progress our Roxadustat at universe.

which adopters practice. also China. the CKD are pleased larger Class than and in market potential to-date X accounts where the we are listed early opportunity We are hospitals XX% Top-Tier the We represent the with opinion penetration and institutions, greater as key particularly leaders where believe of anemia

QX quarter. roxadustat the Roxadustat affected under quarter the just of represents pandemic. inclusion COVID-XX NRDL after million the by first obviously, for in net sales and the sales were were $X

stopped. February, through January was visits late China completely were From down the end locked essentially and of sales

COVID-XX a During visits impacted affected, were that but treating of also time, degree. lesser patients. and non-dialysis physicians focused number and visits to largely on were The were hospitals outpatient dialysis highly

normal, able return meetings in forward committee to are and being rules conduct apply. QX, to we distancing hospital where to expect China Sales a visiting social representatives Looking now to new continue are will sales operations visits to scheduled.

scientific of where discussions and online primarily roxadustat are digital, disease forms a engagement conducted case manner. sharing experience being in virtual moved education, to now Many have

have dialysis both ESA and ESA-treated including patient roxadustat utilization non-dialysis and different patients. naive populations, and We seen peritoneal hemodialysis, in across

of We for inflammation, hemoglobin reduced within the of unique treatment presence to even the in treatment in setting levels, continue as to CKD, achieve particular, of target anemia value given of well be the need route the encouraged iron the proposition in the in oral as by and administration. China, roxadustat intravenous

our advance making you of to work we the CKD anemia as towards look We keeping goal treating in China. roxadustat forward long-term standard-of-care patients the in updated

the will the provide will Elias Elias? who pamrevlumab program. on an call I update to now turn over

Elias Kouchakji

afternoon. an our COVID-XX over recent good the the provide and I months. Chris, to given you, would pamrevlumab Thank program, development like Today, update on

initiate the a our randomized III a ZEPHYRUS, to in last named evaluating double-blind, As developing placebo-controlled three At IPF are time you III all separate were pamrevlumab ZEPHYRUS second earnings pamrevlumab in enrolling and X. orphan Phase we we study Phase know, of in similar announced diseases. IPF trial call, plans

Given vulnerable pandemic, the to to this time III we recent study. order have of this COVID-XX clinical Phase function, enrollment population with in at temporarily pause ZEPHYRUS lung in patient safety ensure decided compromised

The work with safety to top our in to is patients trial. and situation for investigators assess trial and were to this dynamic this our continue clinical already of continuity as patients we who care enrolled we priority, continue provide

ongoing when possible, Prior our to Phase the we we ground enrollment, X preparations, of the these pausing To were the we to to ZEPHYRUS such will initiate preparing study restart enrollment, hit as able we extent running. trial. III focused in accelerating enrollment are on ZEPHYRUS continue

trial randomized double-blind, cancer ongoing our LAPC, is patients placebo-controlled unresectable with in to or LAPC. pancreatic locally-advanced on program. Moving III our Phase LAPIS

As have the clinical regulatory and to and trial comply prognosis our you with site and working changes, great and with to implement investigators these staff mitigate are risk patients guidance. patient which we government know, a

a from healthcare second DMD significant initiate III Duchenne as pamrevlumab DMD evaluating LELANTOS, communities. providers patient in health Phase for to half dystrophy prepare of There to continue interest is for and muscular the a XXXX. trial, DMD, treatment We or a the

a This be X-to-X non-ambulatory double-blind, patients and randomized weeks. global III XX of in randomized trial of to placebo-controlled trial have period treatment DMD. approximately will with placebo patients a XX It pamrevlumab Phase enroll will

for Cotroneo call Now to Pat turn the will Pat? our financial update. I the over CFO,

Pat Cotroneo

Elias. you, Thank

$XX.X As in the was quarter of of as revenues million, for $XX.X roxadustat compared development XXXX million plus today, total $XX.X million of quarter product announced for the XXXX. consists to revenue, sales revenue in current of The China. $X million quarter first net first for revenue

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

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

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

stated, in when probable. $XXX with financial payments, million previously U.S. our As we GAAP, total in XXXX became of results a accordance achievement recognized the of milestone QX

in The comprised on for amount anticipated milestones in the million EU occur filings, April the second the anticipated Astellas the $XXX quarter related NDA, year. which which from was we was and with MAA million this $XX filing AstraZeneca milestone in of of from X, received to to XXXX U.S. expect connection

balance continue estimate cash, forecast investments to $XXX receivables and data, latest $XXX cash Based our range equivalents, deposits, cash these U.S. in time NDA the of approval restricted on the million ending our payments to in of million, assuming XXXX. milestone we QX XXXX and to be

we $XXX million on $XXX the the total a next milestones million ahead, for U.S. and for over first Looking plus in $XXX of milestones and submissions, commercial the have Europe, approvals milestones of includes aforementioned months MAA which of million sale. anticipated XX expected

in point in time, anticipated milestones XX over in next no At any this the we months. changes have the expectations of

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

Enrique Conterno

quickly to to Pat. well possible. is the you, roxadustat our across In these and FibroGen as partners Thank committed globe many as We, times. as to uncertain making patients closing, available are positioned navigate

ample of of clinical roxadustat for drug supply and have product meet to ample pamrevlumab trials. for the demand our We supply planned year

the first quarter. sales of financial roxadustat As position ramp $XXX end with is up, at approximately in our strong the cash million

includes We of $XXX milestones U.S. $XXX for plus in next total sale. which have of milestones months the $XXX and filings, and expected anticipated million Europe, XX million in the the commercial a on million approvals MAA milestones first of over

on for development of our cash we received million roxadustat in years XXXX all XX-XX we Based in these well addition, $XXX reimbursements current we share geographies, forecast, to million our full expenses where the to and estimated believe reiterating In be except are range China, to of partner financed and continue are for $XXX AstraZeneca. commercialization come. ending we with to

for would Now, I to Operator? turn to operator like questions. the back call the

Operator

from comes Instructions] with Our [Operator Yee Jefferies. question first Michael

open. Your line is

Michael Yee

questions okay. can guys. me Two Enrique. from Hey you Hey Peony. Hey me, if hear

Enrique Conterno

Yes.

Michael Yee

came was this out Maybe talk some week. recently to could put There data just that how you competitor about that into context.

where they segment incident, of had population same the XX% ratio hazard dialysis the in only think, Importantly, of the upwards had I yet have X.XX. you XX%, of guys and you

dataset try dialysis that both and stable maybe that incident So, what compare in that you and talk to mean, would dialysis, when data? and

China. you to as some my there. modeling you Chris, had then QX Maybe about sales. on ramp question And people second Thank how I you. talk is QX, good QX, are thought comments expect

Enrique Conterno

I for China be But of to am able will comment the me question the to think ramp to excited share I for questions. of in in make you sales HIF-PHIs, Clearly, let am on the validates are the turn going data to questions also up. differentiations Peony? Thank roxadustat Peony. your excited why this competitor just data on to way. I recent go in so an we and Michael, But in terms important for Chris about a good. Very then terms much, we that. very us over

Peony Yu

as you, question. Enrique HIF Enrique of you, said. data the Recent Thank the for asking thank and Mike, reaffirms safety the class,

remind compelling. reassured opportunity In roxadustat. a product the to aspects is that the This of us about are great differentiating roxadustat is addition, we profile

and endpoint, translates then roxadustat in transfusion dialysis numerically which is of statistically turn, clinical efficacy in superior standpoint, hemoglobin Now from into reduction an of benefit efficacy in patients.

superior efficacy baseline comparator less of to was and P-value an met after change XX primary endpoint from non-inferiority weeks Our XX X.XXX. than active comparison to to we the is

in transfusion have significant statistically Now, we also what very – reduction is risk.

we furthermore, MACE. in in a in dialysis And Importantly, the cardiovascular we safety reduction demonstrated MACE+ demonstrated and risk. overall population have

four within with dialysis risk the to risk alfa roxadustat XX% lower of roxadustat In of XX% and pool, comparison had a relative epoetin dialysis of epoetin with cause mortality or a towards trend first between patient our started alfa. than MACE alfa months lower X,XXX-incident epoetin lower the where MACE+ initiation,

dialysis Now stable this treatment is have who period this includes stable of months between within well receiving highly-relevant incident four the treatment is of dialysis years. as is into – difference two into and a the dialysis the started incident continue that, around average point Patients entry the the and population. study. The dialysis entry, study enrollment timing of patients describes the

And to study they stable on a other dialysis the up been months dialysis, you than patients treatment. address the for dialysis all of entered about the who the brought continued time that subgroup patients – question that have more of have four are at and

When dialysis we roxadustat conclusions stable have evaluate or about the we safety cardiovascular safety, of on change the at look being looking at that the the efficacious. converted any does patients patients not and and it – and safe –

in so, safety epoetin a relative rate better the efficacy together coupled option significant statistically transfusion clinically makes meaningful, profile, cardiovascular patients. higher and alfa, dialysis-dependent roxadustat results for conclusion, treatment And potentially excellent and to lower roxadustat’s with hemoglobin

on label have the our expect we product the hand compound. of the like and results to that clinical We reflect trials

Enrique Conterno

math stable them. appreciate I versus Okay. -- yes because that population question and because, the of the doing around the

incident China? maybe Chris, I response important, on and and So, is appreciate the

Peony Yu

Chris?

Chris Chung

fourth be Hi, you you might continue look optimistic to the the numbers numbers QX quarters. Yes. about at and numbers. we saw saw and be, to third second, the Mike, way so QX The

the there China. So, is seasonality typically you? the So, QX of tell in when in what coming does things numbers terms

you prescribe. can’t you as without So listings know,

NRDL key. out because is it list, affordable drug it are and makes also, hospitals momentum makes tremendous list. of But there the a wants listings coming to So

coming are we very reflects of So the with happy It numbers. QX out momentum NRDL.

a reflects of bit slowdown COVID. It of because a

COVID new but rest coming so normal. it’s hard of continue very are a looks predict based what to optimistic of be to We into the out the It’s we it, now on like. bit touch-and-go, little in year

Michael Yee

you, Thank guys. Appreciate it.

Operator

our you. Leerink. SVB Geoffrey question next with comes Thank from Porges And

open. Your line is

Geoffrey Porges

am going Hi. this what’s that Hypothetically, first of think than you out your they’re significantly in play Or In larger over long-term? the think will of Chris, do you equal? all, one I that other? DD, be the is assessment how NDD curious, do versus roughly to ultimately China,

I then, will situation given not to you. commercialization, for be your the love but think your think Or non-dialysis again? know responsible I’d larger claim? greater you data? dialysis, be dialysis incident think the in what on opportunity you’re the be you And the Enrique, U.S. opportunity getting Thank hear Do will that the you color that in do will

Enrique Conterno

Geoff. good, Very

try me both Let address your of to questions.

that have larger. on Looking relative clearly, of number non-dependent-dialysis, and size dialysis patients dialysis is, course, much at of anemia, the and but is patients that opportunity to the non-dependent-dialysis both significant, of the help much, are in

opportunities in over much larger be But view than the opportunities. I patients opportunity non-dialysis-dependent both the to in as time, the view important I opportunity dialysis.

Of the patients course, that treatment we for do CKD. will accessing are ensure anemia, need job to our to have patients

know way, course, in the comes I had to engaged with to AstraZeneca. opportunity engage, a you of U.S., to am roxadustat but and the we completely ensuring a it can have that successful minute it when When comes I commercialization of this I give

opportunity time, there potential be develop a over similar market are that significantly China follows, as the and treated. being has we ensure patients comments The to larger, I situation NDD that think, we in

coming in at we in prior months, months. them of are look XX% Keep in prior those look for at to patients treated when twelve anemia mind, about twelve we and the today only dialysis that

treated huge get think to that ensure So, a patients many a I opportunity, for there. many, opportunity and great clearly, market expansion appropriately

Geoffrey Porges

Thank very Great. you much.

Operator

with next of comes question America. Our Bank from Jason Gerberry

Your open. line is

Jason Gerberry

Yes.

in curious, later I a looking if publication comment will ASN on you be year. make strategy, Just competitor XXXX this can to your your splash roxa imagine

instance, is program, study. know there for so, the on data data I the that subcomponents for And MACE the points regarding some the roxa DD

demand-driven year? incremental data at And we think front? Just $X for any all guys if And can China of us number a just get then follow-up Is on for published could you million about if a you that more the out later curious, number? Chris. quarter. pure comment maybe this this Help that

roxa, talked you I inclusive assume, XX% building. headwind more the mentioned market conversations, think of have I NDD you in but market the of COVID to prior about hospitals requiring access

least should at So we as more you. being the around access the about Thank onset? that at think DD opportunity,

Enrique Conterno

Yes. question. for Thank ask on the strategy. publication you, Peony our I going am to to Jason, comment

We color to to that – to do I planning, about we this more publications give ask the publication are China. going what excited some Peony? And we are then Chris us trying are am year. on

Peony Yu

could over to are – our partners, say – Yes. submit I about our plans. studies, as very with publications we Astellas we our III can I coming and are individual am manuscripts very some excited closely and publication upcoming well that working safety data-rich We and for months. AstraZeneca, two to the Phase as we pool efficacy committed are

of plan number to will also October this tuned. in which to be of submit ASN, you. Stay year. a We Thank held abstracts

Jason Gerberry

you. Chris? Thank

Chris Chung

I Thank you, would to and want

Enrique Conterno

yes, little answer I Chris, on – question China, am – provide more if you color. the could I please

Chris Chung

Absolutely.

answer no. revenues a incentives, is, demand Beijing you discounts, minus XX% particular, pure ex million the the orders is represents the if channel. into commissions. is distributors’ In which factory Jason, revenues, The represents net which or net number? So asked from is $X it So FibroGen million $X VAT,

a number inventory, really difference the net gap. is channel between channel. it's So the demand into number the pure The the

So demand factory net this number. a It's ex is a not number.

I believe question, asked second The NDD. is, versus DD you this represents whether Jason, more

or with significant currently now. patient impact what market that not the the because long-term, said and patients more NDD has consistent we in can a In treated we is are they so what Enrique seen So, far have very either population just undertreated. have

But that is a build. market to we need

HIF-PHIs people with standard-of-care a are to starting standard-of-care It's are incident a treatment pattern, converting it's well-established or DD, where HIF-PHIs. market. either very substitution patients For from and

encouragingly, the patient types, adoption hemodialysis, and is non-dialysis. seen have very which dialysis across peritoneal all We

you're number NDD. in based the the So, channel from HD, and on into of from factory our shift terms revenues seeing PD is in demand

Enrique Conterno

If I…

Jason Gerberry

Great. you. Thank

Enrique Conterno

if just bit. complement Yes, I could a

As XX post-NRDL you very to I be think, opportunity to – overall market I able To significant. is basically responsibility China access I at listing, well, know, was XX% have the for as Jason, had when Lilly. a of

we So, – opportunity a be used listing take great China. that's to We to to years able meaningful access progress. basically post-NRDL in have market companies

there the FibroGen want I it normal as think I comes stocking that's encouraging. net we million quarter while The to sales, extremely $X to a say, we was and for wasn't anything, make when QX, do sales, sure, do nothing expect meaningful QX are at ex look unusual just would ramp the is very and up. stocking. there QX, I the

Jason Gerberry

you. Great. Thank

Operator

next from Stifel. And Adam Walsh comes question Thank with you. our

is line Your open.

Edwin Zhang

Hi. is This taking on Thanks questions. for Edwin my Adam. for

damage, on one, including have know patients, even from fibrosis. there COVID-XX. studies We First who are lung have suffered recovered showing those published that COVID-XX

patients? I explore have other you to pamrevlumab a any I follow-up, And pipeline plans may. COVID-XX in or do have So, assets these if

Enrique Conterno

fibrosis. comment, in to ameliorate you two lung the just, are the also COVID-XX. Thank setting Adam. And acute patients applications to question, setting for but I Elias and we potential improve Yes. going to we to ask see to oxygenation in planning am hospitalized with study your post-acute in pamrevlumab

to opportunity to a going now are be patients COVID-XX. to able or to make Elias? Elias few to more help excited reasons this am with comments additional why I ask about we

Elias Kouchakji

call. your for you Thank

currently we saying, So, as are discussing European looking at these regulators, we such studies studies FDA and these is are the as and other with regulators. Enrique

these first We stages the difference and COVID-XX, residual studies. two are is as And the phase, the with moving XX the of planning phase. we acute forward for know, the is, there days

there acute is difficulties Pamrevlumab a can in big leading part effect. these phase have treating some to obviously patients. important a that oxygenation, the is is, of of lot is lack which In is

have oxygenation. show, can affect facilitate we leakage data We that vessels might and and edema the can of the that reduce some to at level the – the is it

know we our is discuss fibrosis, it which the our that lung we this to showing from Respiratory is that specifically planning In potentially soon of the we and interstitial are similarly is progression and long-term, slow these stop and is fibrosis after fibrosis, that studies have or patient move we lung that In good on we affecting down fibrosis the so, this forward fibrosis disease, can Distress with that forward radiation-induced planning and to IPF, them. effects shown lung believe Syndrome. Acute CTGF

Edwin Zhang

great. Great, to the Earlier review upper this agreed you – you. one. margin is the is hold you My a assume standard we week, next of it approval? X.XX, non-inferiority bounce that competitor Should discloses FDA. which of the by or and same Thank

Enrique Conterno

Yes. Thank answer you. to I this pretty will quickly. try

both overall think quite stated have we this that NDD before, the and we we I feel on data have that basically DD cardiovascular is compelling.

benefit And presents we feel risk important an has that roxadustat an important – ratio. it

of decision terms of part we that questions the benefit for confident but before, and Thank stated show about review non-inferiority product have been we able be has. roxadustat, what the will a feel we a very in risk profile As to you.

Operator

next question Cowen. our comes you. Werber Thank from with And Yaron

Your is open. line

Yaron Werber

can you roxa with used. TDAPA. of the early specifically, included, a With drugs comment TDAPA to the incentive a I question ahead thanks for I maybe setting in benefit to on really don’t a it's the congrats little like I Hi. question mean, dialysis start. year, China. to U.S. terrific it once into next off and your had my Yes. know should quick looks just And get relating thoughts, have launch, taking financial and if bit and a like

DaVita – week, decent much but getting really medium-sized it I much faced dialysis bigger Amgen Earlier, a and was Parsabiv of clinics, into headwind sort noted think uptick has that last seen sort Fresenius. of and in small

make of sort So quick how more thoughts them? would attractive of follow-up well. I for as about, And you then, roxa that a have to sort tackle

Enrique Conterno

Yes. you. Thank

incentive your question. make product TDAPA it's for to the an roxadustat. sure a as And are I included that think, you such for offers, for think I Clearly, dialysis think thank as designed – of products innovative protocol I centers. part treatment

receive we approval, a Just little system. process, will this to under submit to – be maybe we for bit system, this TDAPA to have speak the once reimbursed about

we within will designation. that that months, to expect be get We able three

them And launches, AstraZeneca fast. case, innovation very large adoption reassured included be clearly, just will centers and and clearly, can that that adoption, of as the in this to the we like think about closely you and we particular dialysis in the best with preparing ensure can included dialysis patients the working that, possible is and in that their treatment for are we be key we any is in that of terms have organizations ensure are, is

But So, for plans solidifying plans feel other are how now. we companies. I those I about the can't speak and good

Yaron Werber

another really you. question. us data for dialysis the do its to you've for upon have it incident done dialysis terrific own? At touched plans I Peony, this, the job on just And of prevalent think patients a the you the dialysis markets. about I curious sometimes, mean about maybe accounted dialysis overall Okay. you XX% and data just and showing Thank prevalent in the as release

Enrique Conterno

data? it going when address I if it are assume about is to – what the stable question. comes to that releasing I that Yes. dialysis. talking Peony particular and am to Peony, plans ask our

Peony Yu

Yes.

patients in As contains our and entry that's I they incident treatment so four into mentioned, data are the was first patients. the prevalent data receiving the study months, also dialysis the prevalent that. dialysis Incident continue and

comfortable results III our that and – with have been – our the and data the that products. at mentioned our months patients they patients that's does I've or Phase about four change dialysis the we subgroup. conclusion studies the dialysis the or are the safety who time confidence prevalent who more dialysis that, on And as in not four than the for have looked enter And stable earlier very we at efficacy

and may likely And remind a that we analysis. necessarily – we is that share was – not that very wanted ourselves there, it pre-specified to will was this data a that, I analysis not

so, with And comfortable are still we it.

within patients to have keep therefore, patients we that that the received that disclosed most months data start study which important, dialysis not be relevant. where reiterate mind analysis first that And for is data was treatment already incident dialysis pre-specified - into the and four have the and the had the dialysis, overall we overall highly consider we ESA who of those XX% and any the take anemia and to in that

add the And am Enrique, dialysis did we anemia want have I to largest in may patient we you pool something? incident sorry. believe programs. that CKD

Enrique Conterno

Peony. Yes. add, only Thank being Yaron that dialysis to about market. talked thing was, incident you, wanted I you The XX% of the the

the think very of for – is right? year, first dialysis of high. I but – unfortunately, patients You’re mortality that’s it's the in correct thinking

when it order to product is it's for anemia a roxadustat – you. starting uniquely We uniquely there. a differentiated important we that to particularly treatment And dialysis having that to is, Thank for incident have going given natural it's comes decision, that So, is in that is found dialysis. believe positioned point a in preference treatment. be

Yaron Werber

you. Thank

Operator

next comes our Thank with you Choi .And from question Paul Goldman Sachs.

open. Your line is

Paul Choi

the – Phase the patients for their Thank portion double-blind you be had And Europe. with you. thanks MDS seeing roxa? just first to are questions. hope the just have time you receiving doing Peony, MDS my then, – thinking And lines, impacts our potential to on and everyone. comment taking conditioned treatment hi, a Can before I for about to follow-up of is given any on maybe III regards and I that Maybe potentially are trial. well question for you

Peony Yu

Okay.

Enrique Conterno

ahead. go Peony,

Peony Yu

a trial sideroblast-negative. The who includes the trial, and of our MDS who ring then, trial it – Yes. and another in unlike that includes I who product hope also terms study trial failed Europe. patients are answers. ESA. and in have patients those and sites includes I sideroblast-positive wanted design, patients global and And are U.S. we study treatment-naive that, ring in are is to clarify

the the Society as the And are ourselves of remind I to, XXXX. open-label we at portion the also placebo-controlled data Hematology in alluded study just wanted that that, at now of study. then, a of positive this you very question. double-blind, of encouraging answered of Hope have segment And we American share the

Paul Choi

Do the given COVID situation any in and maybe line the different with Peony, you to I it risk conditioning. who to to time the for to put or guess, a Phase have just changes go III? MDS through your chemotherapy patients see way,

Peony Yu

Oh, okay.

impact following the reasons, Phase for Now – is transfusion-dependent. I little already trial our enroll because, our patients III there actually, a the on – trial we now on are wanted

need do words, healthcare to – or and they in they system. be by tethered are So, the are to treated they other monitored their physician

less risk think translate in that be exposure can provide to less And could favorable, view, reduce where about into have risk. can as patients oral participation the less you we make it's our – an sense? That it if – think that trial, transfusion. transfusion, medication will of Does about this it require this way,

Paul Choi

you And forward this Europe, your – are the the Yes. the you views Can yourselves there? you you see MAA different and maybe regarding on expect you think you maybe between you. on two to helpful. look here That's regard in as what approaching then, populations. adoption the on with go Thank partner launch think and how coming there comment much. about the just the might very commercialization, about curve as European quarter early in Thank here roxa in or using might as

Enrique Conterno

stated, in – we in a but to quarter. question markets Yes. know, can behave make in second comes you you some forth. need This are this we And Clearly, keep have expecting as away, markets, good a Europe, Astellas, right can the clearly, the as filing is to different we you it and when product that product differently. mind like launch Germany so in for Europe

to reimbursement. get need to some able be In – some through other go you markets,

Astellas be helping So can Europe. there they we is of much comes market-by-market as going to when commercialization in to to look that it are as the and course, really we forward decision drivers a

Paul Choi

questions. taking Okay. Thanks for our

Operator

our Thank with Difei question next Yang from Mizuho. comes you. And

line Your is open.

Unidentified Analyst

I for taking Thank you everyone. setting on U.S. for This in a Alex Difei. question. Hi could on was the is comment little if the wondering you NDD bit the

interested was in having I are could that benefits Specifically, there? in the today? ESAs comparator How placebo – think if are the of what And used you do a about of setting? what is care you talk standard

whether was with approval? expect not would Thank that, I or along wondering you then, And the on black you. warning box

Enrique Conterno

that am this on have, the box. Peony. decision do to part NDD what to pass the black question. to of standard-of-care. data, Very I’ll for this to not But going we I Peony good. is is the a am Clearly, I that going said last to try your we think answer try we regulators. the and a comment wants data to I believe the ask

have Unfortunately, that many patients not treated do anemia are anemia. for

And in Peony, standard-of-care NDD maybe to United States. provide in talk so, an some is for the improve there treatment rates. you about can the color the and – opportunity But

Peony? Hello

Peony Yu

reminding just me thanks for I be Sorry, to unmuted. –

improve this for We that need an largely for thank to question. So, non-dialysis-dependent you a population. the anemia offers medical do believe opportunity and roxadustat is care in this patients, unmet great

treatment in safety I is mean keeping is by that, XX non-dialysis their there cardiovascular limited risk. the transfusion with to of evidence than with patients a that hemoglobin associated because that concern of than extensive keeping is less What ESA literature, XX. less higher is of hemoglobin ESA, patients And

patients. by month the the prior. since And so, USRDS treatment data patients, of along with has the there patients transfusion label exposed gone rates in entering have ESA the the of rate the dialysis to non-dialysis XX.X% about the that in non-dialysis XX XXXX And is been of in well-known reduction ESA in is the reflected that, change only in this up

translate comparator, that the have does the is chosen we reason U.S. since as care the placebo for What no main is this roxadustat? This in the standard-of-care

in demonstrated of and goal. the placebo III XX our treatment about a importantly, our this our now placebo. – and reduced increase in hemoglobin at significantly have Phase level program, treatment a hemoglobin compared to resulted and And is third And to transfusion in we only significant what is around

for to because, And high has a as were so, comparison placebo, an in MACE+ to one ESA, we box – gold comparator in safety placebo bar that the – agent, choose MACE a comparison is I offers that have point have the safety. - endpoints. cardiovascular for safety, that wanted placebo standard. and if demonstrated to comparator out a we also already warning But, is cardiovascular that as for cardiovascular With demonstrated endpoint

Enrique Conterno

Yes. good. Very

Peony Yu

were Finally, not repleted, iron not our XX% in finally, talk requirement does – for our is our which program, of ESA. a patients

level So, reduce are expand more even not a of to to transfusion, treatment treat therapeutic as only patients we be patients, and the able have able you. around. much Thank iron hemoglobin to we they don't going are to when more to

Enrique Conterno

you, we extended Very we And our Peony. have good. already I time. are – that know Thank

much. for joining So, call you. I of of want FibroGen. to and very our your thank everyone you Thank all for support Thank

Operator

call. a Everyone, disconnect. this conference Ladies may Thank for great And you day. have today's now concludes participating. and gentlemen, you

FibroGen (FGEN) 9 May 202020 Q1 Earnings call transcript