FGEN - Earnings call transcript Q4 2018

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Operator

Welcome to the FibroGen's Fourth Quarter and Full Year 2018 Financial Results Conference Call. My name is Adrienne, and I'll be your operator for today's call. [Operator Instructions]. Please note this conference is being recorded.

For opening remarks and introduction, I'll now turn the call over to Ms. Investor Corporate President, Vice Bergman, Relations Communications. and Karen

Karen Bergman

afternoon, you today. so thank you, for Thank good and call Adrienne, much everyone. joining our

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

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

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

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

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

Thomas Neff

everyone, us. call, In our very, joining have quarterly very since last we Welcome, been you thank the busy. and for period

but first with CKD, stage disease, Medical key peritoneal approval to accomplishments over approve People's XXXX, Products Let we hemodialysis the in with from including roxadustat, a and update chronic On for China XX FibroGen our roxadustat regulatory an number patients December begin of incredible Administration for days. me from Not for other country last on with of kidney received National this and China the the China Republic innovation anemia. CKD dialysis. and first patients is patients for represents for the or only first dialysis anemia of XX,

commencing of China third of are We few the next to a XXXX. months in in commercial and in plan the quarter activities variety launch

a incident or dialysis ROW HIMALAYAS; in and non-dialysis-dependent or X,XXX the composed In EPO, these study. Study Following III in of very our SIERRAS; in dialysis in dialysis initiated shortly we partner, patients, newly roxadustat CKD previously top program as X stage XXX Study China our on and patients well finally and from studies, or -- for in we on the XX, ANDES is results enrolled line December the X,XXX patients of announced non-dialysis. global XXX XX U.S. X,XXX after AstraZeneca, total dialysis Phase as approval

MAA, or authorization adjudicated from to in Medicines partners the studies these results. these our fully application, of with the as EMA. and We as well European and NDA results our line believe U.S. All Food Authority, support top trials Drug positive marketing have or our to The include NDA Completion non-dialysis, to Astellas' are enable including In second we assessment procedures our the XXXX. adjudication is be of for results, consistent safety bias, planned full without adjudication of quarter the FDA. completing included the XXX. track on Study the procedure to MACE in Administration

We point, that strong our in X partners' top in NDA from leadership, and file also to and am move the data will MAA quality Apart patients dialysis Agency, as NDA for study the as this to have the interesting Astellas which anemia of patients of describe approval report population is discussions September very The preliminary half later. III I in Peony conviction to a in first and be CKD our are Phase second XXXX. in PMDA Astellas At a the regarding by XXXX, where expected China the rich of well not submission under our data emerging, may outcomes the is studied Japan. is against on line placebo. bit in of Pharmaceutical the a pleased more discussions Japan, is in date on and extremely review the and diverse a to which measured there with in life, ahead clinical CKD in teams largest with Medical NDA an at data little data studies, population, and each this over have including of reporting year. AZ dialysis decision treatment in Devices X,XXX submitted a total or which been program progression based There the of on set detail review currently on to PMDA, prospective renal counterpart and this

syndromes to turn myelodysplastic MDS. me let Now or

made and respect X at as points where China end is for or requirement III increasing months in the systematically we're then in anemia II/III -- Phase with double-blind, very with the good U.S./EU we and first portion, it data, indications, by X.X recruiting are looking to seeing weeks roxadustat study III In have longer placebo-controlled open CKD, Phase as the are In up of the sorry, grams have the patients. and and seen to the study. the we a I'm XX other forward period several of deciliter In we transfusion by demonstrate MDS. successes decisions or X of hemoglobin end a China, to U.S./EU effectiveness being of we or where reflected which of is treatment move point this Phase to portion It's Beyond open ongoing. in enrollment ongoing in elimination more. portion our evaluated partners study, label our label study,

in II both We moving Phase and in are regard. are our the this ahead U.S. or CIA, our anemia, in in program supportive of partners chemotherapy-induced

pamrevlumab. to Turning

no We pulmonary Elias fibrosis, indications will pancreatic this speak unresectable where call. IPF. the and are available: options studies of III limited or on, excited these LAPC; or Phase more to idiopathic later advanced two report truly have start to or locally treatment studies in patients on cancer,

positive efficacy the FDA at ATS, safety unresectable IPF, designation for and Fast locally to IIb ASCO in our conferences pamrevlumab meeting study in study Track pancreatic at unresectable as fibrosis. presented a both XXXX, LAPC, our XXXX. for Phase results In The supported design the XXXX with were test pamrevlumab idiopathic to that from we U.S. and reported ICLAF granted patients. pulmonary ERS During in Phase and neoadjuvant cancer advanced clinical Phase II results III from chemotherapy in treatment promising XXXX study combination

or dystrophy, Turning Duchenne to muscular our pamrevlumab DMD. in program

progress enrollment XX of We put XX and are treatment II like the age will, non-ambulatory no this year that in this thereafter of wheelchairs patients specific boys emphasize will all primarily evaluating March to full there stage or complete approved and boys to enrolled. of study in for all which into population, Phase patients. non-ambulatory age for XXXX being means of first We the during who period XX. I time our This consists would eventuality, completed product XX, by is young DMD adolescence. of

very starting April. data the from We year expect to of see some treatment interesting in first

million here XXXX, Pat CFO, Cotroneo, addressing detail more on terms. fourth results. fully finance some quarter Let the diluted $X.XX in top-level reported our the per will we in of net of by or me share provide income EPS call. In later $XX finish

Peony As updates December I here, in anemia million for now will FibroGen please. $XXX.X detail Peony, the XXXX, over later to Dr. provide Pat turn more Yu of the XX, to on And on cash. like call. this would had program. again,

Peony Yu

treatment HIF-PHI patients, Thank any you, first start FibroGen. CKD anemia approval is great novel a the health approval of for here in and discovered The world China which our of the was treatment to roxadustat the of bringing anemia patients, in at for Tom. dialysis-dependent authority's developed

line highlight before on in in met were the program of and studies results primary needed I have our this just has positive their we III roxadustat studies. AstraZeneca partners, exciting Astellas, efficacy the have end Phase some for U.S. announced announced in Phase also III key year-end, and studies CKD points all findings call. shall Astellas and our and of top Europe, completion For MAA. and FibroGen AstraZeneca for and all announced NDA

the by be hemoglobin is of are First point in studies. studies transfusion in These studies, effectiveness U.S. both U.S. in consistent lower AstraZeneca. increase SIERRAS in which those deal AstraZeneca HIMALAYAS with inflammation. with was This high a roxadustat and of to the end patients effective non-dialysis each shown dialysis studies, great dialysis. had presence maintenance XX by requirements of We from In dose for by placebo of Phase patients. to patients level, studies much our higher such iron usual survival by eligibility epoetin all the alfa, risk CKD in of receive the rejection statistically standard as transfusion patients. doses. with red superiority is than III change disease And were mean inflammation, of China efficacy is care such measured overload roxadustat to clinically risk baseline, in roxadustat the patients resulting today whereas of effective the were the ANDES to in which requirements, trial study and of despite a have EPO from blood weeks why dose CRPs find primary all, values; significant show time important, in and reduction in chronic by demonstrating reported on ESA normal of and Other by that stable the from results patient's Phase X -- inflammatory is roxadustat as by previously continue these demonstrated studies which -- Astellas, roxadustat patients Phase our non-dialysis is roxadustat's to CRP, status because by to higher in HIMALAYAS OLYMPUS roxadustat-treated differentiation roxadustat CKD change generally than CRP was Moreover, known Kidney current and the We dialysis In primary X significance were reduction option XX. control in the efficacy. CKD hemoglobin had we conversion risks, Also, elevated criteria active caused cell kidney dialysis III the furthermore, comparing end-stage cell our in when SIERRAS demonstrated achieved to level SIERRAS no dose ANDES hemoglobin this with patients' the transfusion, a non-dialysis of preferred was ESA. patients inflammation. measured in large randomized also hemoglobin in transplant compared superiority red longer was placebo the transfusion studies, shown as alloimmunization. III to end significant than ALPS CKD inflamed presence or between FibroGen, from alfa, big because met these hepcidin ROCKIES there's level III was clinical CKD of in compared to in by of FibroGen, patient infections kidney lower and studies. or comparable study, Phase regardless in a is roxadustat-treated which met those EPO associated dialysis with and over to non-inferiority transfusion current averaged risk, point in What the in when blood for dialysis and transplant is patients reduce transfusion first furthermore, with

to in reduced be -- EPO. shown levels hepcidin than roxadustat was more So are

and in benefit We a say, to treatment. does opportunity to We CKD potential potential ineffective. HIF-PHI studies X our believe in A that and and and could routinely XX from have a is on the has number placebo-controlled potential it than condition of for works showing III over We suggests clinical time, benefit and very in in X-year do is patient's -- our attenuating known declines eGFR renal cause outcome interested in else?" the preclinical the have by time. patients relevant overcomes progression, eGFR analysis preservation measured Chronic correction, function, treatment results Stages to significantly are Phase studies paradigm that function. using have results been drug are Preliminary show on than our is anything offer limited non-dialysis-dependent III options drug is disease the clinical baseline this confirmatory of over to roxadustat treatment as major decline less first the new well CKD parameters or from roxadustat a in in placebo to the kidney the offer generally anemia might full to in CKD to patients. quality eGFR on number of significant presence Kidney treatment roxadustat of be hyporesponsiveness studies. X patients a patients seen CKD impact that you patient's of generally in Phase company in yet severity slowing in with life, glad down received renal progressive and measuring the inflammation. in "Other EPO's Well, higher benefit

Another patients the is patients solid In statistical of the important studies anemia are and sample lot a impaired a power as with of secondary the that therapy roxadustat well design life peak parameters. in a of area have program -- one quality quality III Phase life evaluation objectives. known is of good using we for reference our this these of serves size across Improvement matters and points assessing for complications the large comparator life. evaluate adequate the potential program, end of OLYMPUS treatment anemia. of clinical non-dialysis use and to made roxadustat. of treatment of to non-dialysis our CKD X,XXX of of quality these X benefit to placebo Also, The

eGFR, We of are life parameters. excited preliminary and results about other the important quality in

the of half completion other XXXX. pool these of important first end targeting clinically in are of We and analysis points

study preparation individual safety integrated first in are safety AstraZeneca would efficacy are expect The one efficacy submission we working and Turning the ongoing partners, the Encouraged track for data. by in XXXX. on individual U.S. the with preliminary the and data preparation with patient the safety are studies of III in the and to for preliminary Phase results analyses MACE full pool safety robust in adjudicated in results, in diligently NDA in analysis, MAA the Europe. of The studies the our Results what with the consistent population. ongoing. are half Astellas

third we Given to amount partner, rich treatment the submitted of our dialysis-dependent September for PMDA. on Japan, review of targeting anemia these patients, NDA U.S. roxadustat is under large very In data in EMA in XXXX, by X,XXX X-study Phase and by submission are CKD the in in patients III thereafter. submission Astellas, quarter the program,

to treatment of I'm going the anemia to -- For of other so turn conditions. in treatment

in with notoriously plus are II/III MDS these MDS study MDS non-transfusion-dependent an have for and Anemia we has treat Phase and transfusion-dependent patients, difficult conducted Europe in lower China. run-in patients. period. U.S., to Each in an in in Asia, label MDS III a For is patients to open difference we striving ongoing another make Phase study being patients

anemia roxadustat. trial are the are is advancing in label alignment have our transfusion-dependent Last Phase is by start data of like and partners, top-of-line We medical start a partners AstraZeneca the also to available so anemia U.S. Astellas, support there open turn to need, we II believe I'd which the both the With We of plan study. be unmet in both label XXXX. to portion portion MDS have but in not much encouraged XXXX. and components open to data treatment with our to MDS a Phase of with will hope study least, chemotherapy-induced in readout We we the in. huge to This first studies from back on call in needed, a U.S./European to we chemotherapy-induced both of the difference clinical the III far. make Tom. now

Thomas Neff

go on Head Peony. will Operations, ahead. activities you, regulatory now China Chung, Chris Chris, our our process. share please Thank and of current updates

Christine Chung

with had quite We Tom. for exciting CKD the patients. receiving you, in approval Thank dialysis year-end roxadustat China

Peony, by the HIF-PHI Tom world. approved stated is the and roxadustat now first As in anywhere

a milestone In addition, China. historic marks approval for this

required For and and a a development. country first call approval the in global At the first drug. to authorities is roxadustat drug vision persistence X On of macro like China, planning given in market mission our the approval, of clinical access which and development data in a shareholders drug There's behalf our a study We Seeking significant an country's Reimbursement timing on NRDL. scheduling. continue in National in innovative NRDL thank a access in commercialization to third the the With I is since generally we're for been the approved XXXX, this FibroGen would and the XXXX. and State After will level, gathering this is market our first for confirmed, and means China List, of timing patients front global on requirement has and safe in on and Chinese Agency, innovative The the approval that, there AstraZeneca, quarter that the of was inspection, Class We Commission, was the pending player history, of AstraZeneca time Insurance exciting focusing next firsts. uncertain. first-in-class before anticipate in behalf approval of largely strategy. drug launch first-in-class which are by of into board dialysis NRDL reviewed XX expected of the for number China. patients. drugs, the that the last the call. X,XXX the for remains including entry to X would Drug National a a regulatory I to the of middle tremendous year. reimbursement time patients, round now planning with line in studies, To update are and Based another in our is Health the who non-dialysis the was has become in company, which in U.S. approval. opportunities, teams Reimbursement The will arm are our safety part February this news and is in in of procedural on update group The now and clinical internal is partner, hand, IV for last company, the plans. like China post-approval requirement Domestic label. conduct regulatory approval China, increases are commercial the post-approval China current NRDL is our already affordability previously updates the The Phase Finance be the of What government, XXXX. on in Ministry the or launch updated of to been as and been being AstraZeneca for on in the on of a included XXXX. safety data share plans. assessment FibroGen site It clinical meet non-dialysis the added be our Medical a XXXX. announced roxadustat

to between dedicated on grown this plan AstraZeneca over AstraZeneca launch basis programs options quarter. has to team in are end XXXX for a roxadustat covering to enable by end The sales, -- and early from apologies, evaluating we prior be access -- and second FibroGen to experience close now. FibroGen around XX XX roxadustat marketing team, commercial And medical, XX launch. strategic and the XXX the of XXX to to of

to time. level and throughout expertise you on progress tremendous launch anticipating look highly experience, launch has motivated, skill. our The are AstraZeneca, again the teams and excitement. your partner, commercialization you Thank keeping for the Tom? of We year. updated forward we're a with Our

Thomas Neff

on you, us year and dystrophy Chris. like will Kouchakji Dr. ask ahead. to Thank Elias please the ahead. go clinical activities pancreatic I development in now for fibrosis to idiopathic pulmonary Elias, update cancer, muscular

Elias Kouchakji

Phase all identifying with diligently clinical the has been with late-stage clinical with of Tom. KOLs, having a address investigators each process, regulators protocols, potential of trial to the our contracting vendor In and vendors. It's with our meeting more for pamrevlumab, been critical launch identifying demonstrated fibrosis on we XXXX, pancreatic keeping enable fibrotic that double-blind, worked to IPF CTGF that advanced that and patient of on well pathways treated dose-limiting sites, initiating cancer To study and up trial owned, no some the therapy which you, included III our on programs the targets a these Thank in clinical for has gemcitabine first-in-class inhibition pamrevlumab identified. wholly of studies date, one an our as we aspect tolerated Targeting patients III approach across years, DMD combination range of XXX in with X In how evaluate nab-paclitaxel. cancer, and diseases to diseases in key to Pamrevlumab candidate of than been in pancreatic randomized, treated while our Phase pamrevlumab cancer. in neoadjuvant the study track. toxicity the progress. multinational, have a are pamrevlumab doses placebo-controlled in locally process pamrevlumab in will is

combination, enrolling requesting be the study a will survival. study discuss our provisions design a under the The we patients to approximately this trial, application in and meeting we II with will the marketing this rate this similar study. pamrevlumab resection and is overall will We resection of favor Phase Should FDA of be approval. and in the accelerated resectability assess to XXX

study IPF. population a multinational, Turning III second we evaluating pamrevlumab placebo-controlled who patient the in In to are double-blind, quarter, therapy. receiving not a approved Phase randomization for of currently will initiate

XXX change will patients. this end percent approximately in FVC We be predicted plan primary The will baseline. from to point trial for enroll

Moving II non-ambulatory Duchenne ongoing to in our Phase muscular dystrophy patient. study

of X complete assessment on of thereafter. are March therapy all this year target and to for year in We patient

entirely With on for potential diseases year. completed we patients another and two treatment and their three new therapeutic an and started fatal. that years are has And the will of progressive, group Some third pamrevlumab we debilitating years started on have option treatment. of pamrevlumab, to of of develop have already completed these be fourth their believe therapy year

pamrevlumab in looking to updating turn to forward your will on Tom. you for time are X I indication. Thank you and back call We these today, progress the

Thomas Neff

our Financial Cotroneo, you full Pat now please the quarter fourth Pat, Officer, financial Chief highlights year. Elias. you, will go discuss for ahead? Thank and could

Pat Cotroneo

Tom. you, Thank

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

items For pertains product partners. year. the same Total expenses compensation ended totaling $X.XX share; totaling period, the fourth per XX, $XX.X to revenue ultimately, and in million approval-related the totaling development operating million expense XX, last $XX expenses net year. expenses commercial million, compared represents a of operating and of sale, Included was $XX.X $X.XX and which first, used to the share or for shipment for basic share milestones the $X.XX December million; diluted $XXX revenue and year result $X.X were $XX $XX.X XXXX a of net ended period $XXX.X for the of in which of fourth million be the million, was XXXX profit noncash $XX.X resulted reduced for XXXX, an as loss was license pertaining was as We XXXX, in for $XX.X work our China and operating per stock-based million of million, validation same noncash from the burn per to nonrecurring $XX million. API which approximately which in basic and in was to in quarter shipment result Astellas quarter second aggregate diluted to a second, income December to aggregate million, a compared prior million which million portion quarter: compensation an expense the roxadustat or revenue, stock-based noted $XX.X million the $XX of totaling and few net our portion

diluted same net $XX.X time million, $XXX million expenses result and compensation a the million equivalents, totaling deposits, December noncash million partner period, net the $X.XX stock-based of an or operating XXXX, was had was and loss cash, which in $XX.X million receivables. Included At and of $XXX.X share. cash reimbursement, or was December FibroGen portion XX, for operating expenses per ended aggregate XX, $XX.X For year restricted investments in $XXX.X XXXX, expense. were basic million of

the For year-end are year we a $XXX balance the million cash full range $XXX to in of currently projecting XXXX, million.

NDA range, in milestone $XXX.X majority filings. MAA this Our the Thank will you. the I call filed therefore, vast Tom. to back of judgment these approximately anticipated are is that which over associated be payments, this and roxadustat will includes now with year, And and turn million like to

Thomas Neff

will roxadustat therapeutic indications. Thank across XXXX. for pamrevlumab be busy promising Starting highly roxadustat exciting and you, year Pat. XXXX multiple and in with a

We expect to the the in NDA submissions and XXXX. analysis quarter have completed second adjudication MACE for the to MAA support of

partner, to of on of CKD first Phase III CKD Astellas, trial placebo-controlled of submit MAA advance we also Japan, Europe, to an scheduling submit dialysis-dependent expecting a in in add anticipate a and of XXXX. U.S. completion roxadustat for treatment the In submission study the roxadustat we that, label NDA XXX half after second non-dialysis-dependent Following roxadustat we quarter half double-blind, patients expect of approval with third anemia. the dialysis-dependent inspection XXXX. decision in the NDA. plan China, to and and expect our of non-dialysis-dependent U.S./EU portion XXXX. and we dialysis-dependent of the we NDA and CFDI In sites In our the then the Study MDS, non-dialysis-dependent for chemotherapy-induced for will of our to anemia and CKD to FDA In are the U.S. CKD in

in XXXX. start expect our We in enrolling in Phase to the II patients U.S.

underway. neoadjuvant in therapy Phase be For pamrevlumab, LAPC nab-paclitaxel will our randomized, evaluating first-in-class with placebo-controlled anti-fibrotic pamrevlumab in III candidate, our and gemcitabine study multinational, combination double-blind,

double-blind, IPF XXXX. in expect We the pivotal to III Phase commence the in quarter randomized, placebo-controlled study second multinational, of

reporting juveniles, quarter, Q&A. predicted back line non-ambulatory this from percent with we Karen be notable also strength pulmonary to top our by ejection Karen, that, II our including please? from With look by to in measured forward FVC, data muscular and Next for I'd left what muscle cardiac test, function ventricular dystrophy results MRI, over expect study call like function turn we to measured measured Phase test. fraction to

Karen Bergman

your And a in thank the are we Tom. call. you, I'd like Thank experiencing for everyone while starting little to technical patience difficulty today

now moderated by call Tom with you. the open Let's questions Neff. Thank

Operator

[Operator our Jefferies. question Michael Yee from Instructions]. And from first comes

Michael Yee

both what final second the to you up to relates eGFR relates second delay be MACE it progression out? in the will How able this those? question as that? to are your at My to population? part the populations about you Where you hyporesponder finishing and steps will the And my of it guess important are the roxa as readout? is be would of is question reported are that How analysis, well said dialysis be in And quarter. given which gating I comment confidence and how important as the readouts, with those in point non-dialysis

Thomas Neff

Michael. you, Thank

to it So comments. of this going I part of the question, think sets a second I'm divide into couple

not adjudication on submission. or are dependent progression this post year's the as for results hyporesponse to filing it We relates NDA

for However, we hyporesponse add you patients? do progression Peony, anything Will have very, or would please? to that the about data interested CKD data. very in and like you, we're

Peony Yu

the that hemoglobin when to they want been EPO with then -- for down, the not know Thanks, our Yes, we -- causes -- that to the find able wanted heel and we so and been progression the has Tom. level And and patients important that we Yes. always achieve of be. our the for eGFR has hyporesponse in decline they it Achilles' very patients. therapy, as of for KOLs viewed -- slowing in terms speak

the target end that try and -- to issues. is results then hemoglobin, there safety patient, up EPO then would historically, this get So too given the to be to in then much and to

not requirement And impacted as and positive a and for by dose with So both is efficacy safety a of -- effectiveness our also important with has characteristic inflammatory that been drug viewed in a CMS. status very having this evaluation. discussion

benefit-risk the evaluate So they believe these that example incremental look of -- X they of roxadustat are some and with are find our on these -- of therapy. to roxadustat. benefits we just drug articulation based that the value the will evaluate the of ratio, FDA potential We

Thomas Neff

question. Peony. Thank you, of the other part your Mike,

one different slightly another U.S. in in adjudication the and Europe. an have We we have pool

to adjudication objectives the completed. those So are get pools

of both We will cases. in course, partners our with be, working

treated pretty -- been we'll our it's there's to have that, I where In think make as assessment the dropped with placebo completely as very you new not a where to patients for in this a we being study the CKD go one hemoglobin population study and that of this the -- important to was very they're frequently circumstance. anemia clear clearly treatment saw dialysis, starting things clear treatment So instance, best early. non-dialysis, that before, very X.X. X and forward was many sick And how therapy is and note studies or in This arm possible. it's try at

for best more so will the analysis, update evaluating but do we are, where much of going we I sentiment questions. a and course, we're is you think of see the is. all it's a And complex sort that Thank idea stuff and we in where to what manner the can here we it the can

Operator

Stifel. with Walsh Adam from comes question next our And

Adam Walsh

the quick function eGFR, Tom that's very much the you okay. preserved a as one non-dialysis-dependent as delayed for results that's you these kidney well, non-dialysis lot Tom, execute ongoing manner do now leverage a got well kidney roxa that that inside one and adequately I've by about as the roxa? of if a and company the can where in of, on have CKD community? preservation trials of on that measured in patients. you to dialysis right timely approval and obviously, would profound launch should you and initiatives. you how have the worldwide and implications Peony, as that staffed Peony ton think potentially And and you're approval going for obviously feel Do How you you with planned in receive quickly, a roxa then go with very setting? And potential clinical in result the on maybe for doing then function resourced

Peony Yu

to that being dreaming function I for has from III much have have very program. function been the oxygen And protective to also something a deserves of benefit designed preservation have has to so we been team the see that and you my of HIF-PHI. thank believe for enough a day able Phase kidney the we question. good -- There the Adam, kidney and been deserves the when

NDA, to benefit, best and and show be about the happy question this every the in me articulate And our in our to me -- talk the by are provided do take we to your preparing this opinion about future. more to So advice. good practice it we this while now nephrologist we will have have some time clinician we an that to but are single had I valuable it able be to will tells will

Thomas Neff

to So while. expect of resources, possible, resourcing, a me, and things that question to for with to off, a we adequate have with thankfully, been financial continue makes which respect other adequate we first your lot

selling As I China, in drugs company anemia program the have look China. at we second in largest the

in our of a revenues business nearly partner billion, $X the China. year-on-year, are about year's were in is momentum. This XX% operation They lot up that a in fantastic AstraZeneca launch. so

the a anemia. have partner, In then Astellas. execution it And And in so we resourcing excellent have Japan, we it became so we for And partner think our originally, -- merger feel and like They're great Astellas was after excellent CKD on. we in Yamanouchi. Japan. with Fujisawa,

so at X years. looking these for very you're activities to companies again, long-time big focused programs, these X with on And or commitment

places. where -- And In in I is shape of think regulatory good areas now front a to still pretty so into bit. those getting and us the we're we're little in Europe story the

as in both as observe. have in to the X, leadership, X Europe, AstraZeneca say to motivated In we find work we've years X cases, case we to Astellas very been years partner. going have in have case that but we out have the and of would happen, partner. Astellas of able AZ a U.S., their that in We very have I about motivated in who what's the excelled for teams And a

in so resourcing of activities happen, every we calibrate course. at anemia, amount have rights, Things responsible being adequate And expand ground. step. all as of other are we of on the CKD we not of these holding cases, to And areas can into royalty directly

cancer, With the concepts. And antibody, treatments monumental no There's case simple. that of they're in you've of got programs been They that DMD not are there's both right at it's proof the previously. happen previously. proof been stage. treatment pancreatic just In and of because area, each concept

but with have we on, allocate pretty us, for and potential decide in markets in to a wise to so partners again, around good and rights we're regard. way so And think shape we the world how in this

let So there. me stop

Operator

Geoffrey question next Porges from from the Leerink. comes And

Geoffrey Porges

couple call. things a questions Just that on detailed you mentioned on of the

a you'll give XXXX. in could about about some apologize questions, First that that? X,XXX-patient to when post-approval a might listing? with for us AstraZeneca then list lastly, or talk for Do be is with intend a a but to the affect from disclosure, and Duchenne for so price I doing that of hear you And to you us the that on question, listings NRDL the us study, expectations secondly, we then your with give say in and our commercial you I wait what and NRDL launch roxa announcement sort launch details you'll price how have what mentioned of you able you And think. to I low what you China? you price new mentioned logistically then it the launch Could think see potentially Could all sense that calibrate comes? what disclose then to should

Thomas Neff

me So the address this Chris, NRDL. we'll then out Duchenne, on And second the The there. deal have part. with I'll Elias parse part, that. take let first

ahead. go just So

Christine Chung

do launch, regard before wait no. Geoff, with X pricing separate first answer Those of Sure. until clarity plan to question, the around NRDL we ideas. NRDL are is or to your

We ready when launch. will launch we're to

We for NRDL. will application submit an

it's timing As you timing exact though XXXX, the uncertain. know, the we -- know is even

we're have command, very the valuable that pricing -- proposition demand while to value roxadustat going we're for also And or to rather, is roxadustat, that is we negotiations. very subject to very a While optimistic a considered, is uncertain. be criteria optimistic that

plan So currently, is two. unlink to the the

Thomas Neff

or So for first approval with final well post-approval a which let the ago, to pathway be it in was a regard the might I would oral little time. safety study, study, to than more idea the required was was the longer period went for out Geoff, administrative point system decade me one exclusivity and of we requirement study, an administered was to was first when under a of where PAS mandatory China the of a post-approval rapid therapy, there but negotiate extension that understood we to approval PAS, list, that beyond be --

go and please. what you're ahead address And PAS so that the And Chris, is study think I asking question, about.

Christine Chung

Sure.

both Class So regulatory and drug, we not here, the to commitment of with Domestic in innovative roxadustat. authorities regulatory specific have requirement the are for post-approval safety Elias terms X is and a is Peony met expectations.

to and safety the it. a get minimum or As anything and post-approval study study run of X,XXX is routine it's party AstraZeneca. I far roxadustat the the I a know, that anything who's about not sense as FibroGen to very patients, clarify that did not with there's And is to specifically funky going

Thomas Neff

and for look here. dystrophy we after muscular So are Elias, explain what hoping please

Elias Kouchakji

of Similarly, year test key the at but Tom are completing fraction. ejection still are the we as functions, are doing treatment patient ventricular let's FVC this we with data, others. same for have the fraction, the March, X we to and similarly, clean MRI. heart. muscle for cardiac at MRIs looking the have function, We're MRI. we're an pulmonary our just pinch is time, looking And and pull percent the doing So the left say we at doing testing before, mentioned the we And predicted. in of mid and ejection And the

We until data. will the is the until data enrolled, transfer last clean await the data, is completed, patient the

-- then will looking muscular internal the completely, And at what will -- will when make dystrophy. the and We we an time. of data strategy decision, our see we statutory data how after Duchenne for we that data, will evaluation this at the be be

a good their that positive a and for hoping now patient new have this will mentioned, very be that option patient. -- we And year I this fourth is provide on started of We who are therapy. data as

us is -- hope. itself, by giving that So is

Operator

And our next from comes question Beatty Citi. Joel from

Joel Beatty

I use guess care on non-dialysis for discuss point the important program the clinicians about setting? an you anemia what roxadustat most end and in will prescribing are can that

Thomas Neff

setting, chronic might a that anti-cholesterol eGFR of or course, try lead are that disease aware measured evidence -- dialysis We're therapy can slow avoids it you I'll this disease there be very patients, that as then patients XX address to case, a by aware is medicine. meaning something question. outcome. progression emerging all their over time. we relatively of this maybe the slows that what we It's of either progressive that progression idea answer baseline And of can about roxa XX. and in renal motivated -- In notion are to is think I patients very see kinds as to to Joel, or well, is use the stall Okay. are if non-dialysis would hopeful those of eGFR a down of

of hope So other a With and that oxygen multiplier on get they're you where -- so it's in and for. in more patients their kinds sicker, and would that actually kind that's what that all-out are organs, situations losing more you capacity setting, of alert diseases. an all in

you it's think well may something kinds cardiovascular, and I in of kind pulmonary forestall a that issues routinely are that, categories of effective hemoglobin, or safe XX perhaps and functional so if dosing that other that of medicine. documented numerous medicine And you like with system once-a-week level have can idea,

that's look you for So how we at Thank it. the question.

Joel Beatty

MACE Can question. of used ask non-inferiority I be And can you another analysis? that the the Great. discuss will for if definition

Thomas Neff

in what Where, jurisdiction?

Karen Bergman

hear Joel, follow-on Karen. is question? This Tom's did you

Joel Beatty

was sorry. What that? Oh,

Karen Bergman

you -- inquiring. He in asked which what or are jurisdiction in

Joel Beatty

Sure.

So -- pools will be and let's approval, there'll I FDA that look definition be FDA guess non-dialysis could X my say what from I'm curious and on for used. dialysis the at the understanding,

Thomas Neff

take So do program? ROW U.S. to Peony, want that on you

Peony Yu

Sure.

and we -- discussion in the with FDA. So the now are

more adjudicated it the And who the the will and MACE, on based jurisdictions stroke then be the be are events. plus. is So MI, count reason at -- or patients had of the MACE composite of what be we'll based on it results Tom will Europe, death, of which looking these -- will and have number asked mentioned one we'll use in

due heart to failure angina. be hospitalization MI, to will hospitalization unstable that death, due So stroke, and

Thomas Neff

[indiscernible] the And

Peony Yu

Yes.

and will jurisdictions the to in then after -- data. the criteria also so So -- differ Go we then yes. the -- analysis be and the are of for those -- please. for of And then -- still we and X step completing such are evaluations adjudication, that we ahead, --

Thomas Neff

Yes, else? anything

Joel Beatty

No, sir.

Thomas Neff

else? Anything Peony. you, Thank

Joel Beatty

No.

Operator

Andy from And with question we William Blair. Hsieh another have

Andy Hsieh

Chris. for is One

you a are pay just think -- the addressing could mentioned a population? thinking about modeling I special early maybe program. the From that? regarding company details along And is private -- perspective, AstraZeneca about like access more with provide you

Thomas Neff

the China, me this let little utilization In the prelim prescriber Andy, negotiations. matters So bit. a profile NRDL for

benefit. may So is and... Chris, although private pay, side want a into it this to do be not you really go ahead

Christine Chung

you thank question. Andy, for your Sure.

said. what Tom So access market really program The just I at confirm addressed early access. is

first As this won't being you can half Japan. until the in is imagine, and approval data with launched be second of roxadustat the in China a year next XXX-subject set,

have referenceable started access really experience we're market So prescriber no not of we because we the from on studies. outside IV Phase expanding data any of purposes have for and China focused

give typical revenues free. order to types order or the away have book and bit the do at free; the for into drug. basically X get X,XXX a we our drug part early commercial or for and free get of away the assistance to for And is access in of we So we could used could could people terms regimen program, list in formulary target reimbursement a into we either we give to subsidy the hospitals, are which need a donate samples, patient programs, in this dosing again, of program where we

understand if of to each serve paradigms to might of focus the market access private as AstraZeneca cons it's really I us not situation, for as well chances enhance X with really of those but that this pay. hybrid can a working in pros on there's success. and actively are We well our market

Thomas Neff

machinery second in, will we is other in the XX,XXX to on salespeople. make the is area Beijing evaluating full-blown very sure And kicks I'd they distribution in and last really carefully AstraZeneca heard extensive The the I first around have and the spring, forward. of step, point move that step, focus this China. The

speed fast successful the is someone. so you very the Anyway, up And ways the which partnering on has question. taking, been of decide to as we path thank the AstraZeneca. as virtue we're with there's It pick once for

Andy Hsieh

a Phase so Do Elias, So Can the us behind label another kind the open this what Is the there clarification what's Sure. the kind for for of -- MDS the roxadustat. is I about you entails? question to phase? for if remind label rationale mind open the study one? just III randomized you what -- ask portion -- transitioning of

Thomas Neff

Yes.

help U.S. actually. programs. is weeks bit. such is MDS, test me in longer, hemoglobin In point was of at patients transfusion hemoglobin it's an there, we're end little than naive One let X or the distinct different. increase. the outside The looking standard a we which had And a pretty X So the as in And anything very program, are catches China but X.X U.S., of early more for end that point therapies,

turn so -- to have in over in where there's in partners have the of to a we're now, now enough free. our And what patients today U.S., talking this beyond MDS -- point gone the there's is gotten lot about here that that of was I'll AstraZeneca weeks transfusion Peony data and we

double-blind the study. get on going Let's

explain. please Peony, So

Peony Yu

Yes.

and for transfusion-dependent was demonstrate pursuing transfusion in be So -- that the the we study who study, are weeks. this X study, for start U.S. that and we with for understanding we met before the FDA, will the independence patients

and a that by for X much with patients portion, it's point with the the which to starting the of over looked double-blinded planned XXX now -- very into -- the has randomization. our have data at we partners, -- encouraged we that open-label So at are randomize are we have have gone data and having X a we to

Now have there practical threshold in And about severe and could roxa MDS below hemoglobin them the to blood we if many the for are anemic transfusion increase X. get may do who it transfusion of patients is see below that blood China, study X basis start hemoglobin even more of also. the patients physicians level thinking this not lower-risk the for we with together, around And separately anemic because transfusion, threshold Do where level is to that which to cover most -- -- is MDS have to may a walk very to will patients so a you more U.S., questions? who the need. ordering study, and entire is situation there with roxadustat is MDS with hemoglobin any shortage still a for blood in are around transfusion, believe such different taking patients because -- treat China, a much than by with spectrum result good of have we

Andy Hsieh

is that great think a explanation. No, I

Operator

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

Difei Yang

a Just couple.

is if and pricing. wondering for relative about shed and you to you in The could roxadustat that -- some the how China I'm on question would pricing first light think around U.S. Japan how be

Thomas Neff

please? that Chris, why don't one, you with ahead go

Christine Chung

Thank the question Sure. in China. pricing you for specifically about

of before Class first is of which Japan the referencing will decision the is launching thing, date, the way, based experience, And affect originally we pricing, believe AstraZeneca's the Domestic to FibroGen is business X model. the and is not, approval that or rest foundational, careful a drug. So It on any China also China very China world. is strategic that Europe one U.S., referenceability pricing Tom the in are the we about pricing. is a and not drug combo this by new

U.S. that make to get approval case was used it's in to China. the So data very difficult

current assumption linked. these the are So is two

reimbursement China of in potential prescribers, proposition self-pay proxies the is to couple the agency a potential believe understand level is One pricing which terms patients, roxadustat studies is strong. relative with extensive as what factors. pricing reimbursement potential In value of who patients as China, the we've we very well received fundamental conducted of in to ESAs, had to

for not Chinese of ESAs. if to non-dialysis previously by the population and much affordability that cover we larger dialysis the government roxadustat is a second we endorsed The expect was addressable

affordability portion who the reimbursed. the use and patients HIF-PHIs to choose the is of by is Third self-pay

access drugs the And to into also see, innovative with innovative quite could drugs, that those price we are are there of levied as widely of oncology reimbursed, taken being were finally, So drugs are cuts factors, of significant be in expansion all particular but consideration. because in combination that the will XXXX. that

for, just sells So the can we made the end reimbursed it's to described. what are of at and yet and those be get decisions methodology is I the but really what day, as

Thomas Neff

more ask to want you do questions, Difei, please?

Difei Yang

that you explanation. detailed for Thank Yes.

is So agents, should example, of that been pricing we thinking have ballpark of about? PD-X the for we that the Is pricing. XX% roughly -- U.S. observing, for China the be

Thomas Neff

unfortunately, This complicated. is, little bit a

or think So about $X,XXX might try anemia it. In have I U.S. implicitly, year these that, these -- me of that's would course let dialysis patient $X,XXX normal schedule how days, for reimbursement per in you government-reimbursement-type and Europe, the per a therapies program. TIW maybe and dosing. And

exchange matches don't TIW BIW. the QW. constraint time dialysis onboard with the a have goes or drug So we We can do drug, our patient. the With of

Chinese biggest lower TIW. on one prices by to the by reasonably looking in is price a society. in And government the dialysis reimbursement at much that other can XX% the can to also challenge counterparties some result, milligrams. the are of we at deal than for about at have so that QW talk by we We wealth prices we China, as people top flexibility about And interesting parts if with which and affordable units talk is have

And so happened think other in that that's flexibility have than different we might situations. have I

that kind different sure, way, seen for address of are with negated idea. risk are a the nullified I've addresses In addition, of HIF things where or the they way factors UCLA all aspects are we that XX that -- risk HIF than biology the somehow EPO EPO, from -- also, identifiable but HIF study factors. have therapies, biology

things the still in conversation those things valuable. how without that's a us. part of front a priced so is And But these are doubt, of get

in challenge pricing, and way would is not to with them China make make right. work, and And a I'm that so we're sure we're I dealing do still like governments confident that thing and what in I extortionate can being feel my about pretty fair -- we this say

Difei Yang

think U.S., be or roxadustat do Then the in pricing of discussion turning the bundle out you will bundle? into the the

Thomas Neff

question, think, dependent This is I future conversations. on

of dialysis on. this And what data through call to kind until about years and regulation before been several some was us we decided to achieved talk so wait but incident to them, technology, whole talk new what the they proffer to We bundle or is We process. whether outside entirely careful, CMS, data to have be on here. see time decisions just told at we we wait get because wanted outside that the that it's debated to ago, possibly the make hasn't of being the just

we I weeks here, look think a with the if that it we can see most to can which the what the of how think U.S. right? and we in that straightforward this obviously show are if few So too, can't talk presentation, you'd but mean. have that, about chances book, it's different you outside now is But we to game the simple on. differences I wait is that understand outcome they're it's position, our treatment at clear-cut. government to wait way And and better evolving, and to like we things. get And it, going quantitative show technology think I to to to I sort ridiculous like point to articulately to more think you expect about follow be if

Difei Yang

makes That perfect yes. Yes, sense.

Operator

I'll And the Neff over call that concludes turn closing back our comments. session. question-and-answer Tom to for

Thomas Neff

These III started closer nearly now a long today. To approval market a of humble was commitment. are with outcomes. most see you be work the for products, call, and time apart on to the that to that say The U.S. year way, to amount involved us the to for the do development having the supports each joining impossible that both advanced of in chance everyone period long I'm for multiple promising only, And here X late. We a and from remarkable enormous roxadustat such of I are it's still opportunities those we days decade thank FibroGen we kind just of because so appreciate sorry data. the employees of who effort, our that still of these patients innovative significant in options. I are the can reporting China mode of of efficacy FDA commitment treatment programs we're announced case -- new the Phase need Phase on execution of pamrevlumab, for And astounding. the the III. of really contracting and now we've point are in and doing dedication gotten Phase and in protocols our to agreeing imagine III XXXX

particular, ejection on see almost situation also the wheelchairs. or and, in the the cardiac We and pamrevlumab go on ejection fraction dystrophy promise will muscular begin of where measurements therapy desperate to impact from in into day is the cardiopulmonary therapy boys anti-CTGF --

there hope the what patients. is in potential for So we're very very, interested or those

has Our maintained company its financial discipline.

XXXX. today on partners like and as all our and our with the Thank Phase Obviously, that us look evening. team and anemia who every for So good able everyone the invaluable gods, as in for forward stuff so a we all always you thanks the of afternoon as in programs to We being updated I like biotech sale company, well thank hasn't our would it's investors now, the a contributions fire situation, physician our do keeping a and without FibroGen here. but in world continued, wish you for we're over as through collaboration it here right been far. investigators awesome progress participated I'd to way to delicate to to the being to in okay. member take are good support. this well time III

Operator

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

FibroGen (FGEN) 28 Feb 192018 Q4 Earnings call transcript