FibroGen (FGEN) 6 May 242024 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to the FibroGen's First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, David DeLucia, Vice President, Investor Relations.

Good afternoon, everyone. today results. our joining financial quarter for business and you to first discuss XXXX Thank DeLucia, President David FibroGen. I'm Vice Relations and at Investor of Corporate FP&A

me Chief Juan President Graham, our Chief Financial Senior Thane Deyaa Joining Vice John of our and our call Hunter, Chris Dr. Officer; our our Adib, Officer; Operations. Executive Officer; Dr. Wettig, Medical Chief Officer; today's on Scientific China Chief are Chung,

remind questions. results; Each remarks, subject about projected recent the in business prepared results complete the to differ not Astellas; risks will those FibroGen's future that I and today's from or would Form in our result new business forward-looking on other and can a FibroGen we to guidance; trials; of may publicly could be and strategies found otherwise. XX-K other to materially and information, and FibroGen. risks include, statements statements, clinical statement. of events statement A events our with XX-Q. actual these that uncertainties SEC, matters. your any our initiation, description Following enrollment, development that regulatory operations; but more our cause certain undertake including Form filings limited call material call regulatory update like are financial and with and obligation to most activities; open risks commercial forward-looking does of any research whether results as is collaborations you statements forward-looking made remarks AstraZeneca not to include results related and results of our to, design, conduct to our and potential the and Such

website a call today's Wettig. www.fibrogen.com. financial With I'd release FibroGen's update to our business call be webcast like that, of CEO, over Investors reporting can press and results on the found to turn Thane The at the of section conference our and

On call. XXXX future will our to trajectory. and strategic today's stakeholders our focus first X Dave. on company's earnings Good welcome everyone, afternoon, our you, the call, Thank quarter I shaping pillars,

insights programs. Dr. cancer line progress drug the we offer about top which after will Phase our our will Graham, line feel I'll Chief prostate pamrevlumab the why metastatic review into of questions. financials, top articulate recently FG-XXXX castration-resistant Additionally, conjugate the our the antibody targeted open and in released Deyaa strongly and will our your CDXX so our Officer, Medical data Adib, call and from results review I for roxadustat CFO, Juan we

key offer four pillars significant Starting believe today. on has X. that we Slide value strategic FibroGen

for plan will in a with detail we III our pamrevlumab unmet pancreatic Phase readouts releasing in adaptive is trial where cancer. Pancreatic we represents in moment. Cancer coming First which are preparing from studies on months, the in early Phase from cancer substantial in pancreatic ongoing has pamrevlumab, trial metastatic for opportunity in preclinical commercial which In and pancreatic and advanced both locally Phase from clinical data we an clinical effect disease pancreatic demonstrated LAPIS Pancreatic Precision platform Promise, line pivotal for III cancer a cancer Action Network's top two a II/III and cancer. studies is significant need

potentially This with chemotherapy-induced net to with from anemia, myeodysplastic with decision territories, allows China and growing has revenue Second AstraZeneca material in kidney if through generates with expecting is and and approval over and high for an syndromes. represent is revenue the South chronic would countries, to AstraZeneca revenue cash in China and second authorities partnerships certain regained ROW as half We're partner in such in on Roxadustat excluding by top in of of anemia Pharma. rights FibroGen roxadustat. lower-risk and the XX growth opportunity U.S. which, approved, in indications flow patients unmet the FibroGen roxadustat Astellas roxadustat substantial approved significant for Korea. meaningful associated generated positive roxadustat XXXX provides economics the the us with and needs, disease. the anemia our

early-stage oncology pipeline. our is Third

trial development potential We are conjugate, first-in-class This of these FG-XXXX tumors. other CDXX into will ADC, metastatic on go very data drug CDXX program programs. excited the a or April, cancer antibody associated our and Phase compelling treatment biomarker. I potentially also of an released includes we later call. In about of solid the monotherapy targeted PET potent the is which targeting FG-XXXX prostate for the castration-resistant from Deyaa

addition recently and antibody IND of our [ the submitted FG-XXXX, anticollectinX In an we await FDA clearance monoclonal FG-XXXX, for to have ] application.

our planning We anti-CCRX FG-XXXX, antibody an monoclonal file also XXXX. to for IND in are

our The cash, million equivalents, is pillar with cash We $XXX.X position. fourth quarter approximately cash finished strong accounts the and investments in receivable.

biotechnology assets. to our a early-stage of sufficient FibroGen, our In are future. to few a be you talented expect We balance to strong the assets, shareholder value significant into drive such late-stage companies we strong of at today sheet summary, foundation have that market our into balance our compelling quality that and strong there believe of fund sheet creation and our combine cap When the colleagues our we a and have operating we believe mix commercial, plans XXXX.

the in and on to cancer more X. detail various studied in pamrevlumab pancreatic starting now and and or for novel over and clinical profile. the dose safety cancer development across to X. been pancreatic and of an early-stage anti-CTGF Slide demonstrated unresectable is X,XXX Pamrevlumab advanced monoclonal exposure LAPIS. patients conditions favorable Slide cancer having pancreatic like related responses tolerability and human metastatic a opportunity would has trial in pancreatic antibody locally discuss Moving in treatment Pamrevlumab cancer I

advances patients represents Pancreatic one patients combined. instance This rate the the time. is cancer, with approximately X%. for survival in survival approximately U.S. therapeutic oncology There cancer major And the X-year needs in disease-free been is XX,XXX not some of for The have an largest overall of Unfortunately, across the includes quite XX.X%. of million only annual unmet there nearly any X.X major rate an metastatic regions PDAC

patients metastatic believe can tissue Based an provide shown use plays pancreatic CTGF, stroma as factor, pamrevlumab benefits tumor X, direct role that by data, progression provide pancreatic growth pancreatic or CTGF and connective studies cancer. why biological Mouse preclinical effects locally rationale Slide clinical both for a in to tumors. in On the to diagnosed on advanced important we effects inhibiting have antitumor and the surrounding of strong have an with we pamrevlumab activity on cancer. of growth the both overview and pancreatic can providing

advanced escalation patients with locally our trial to Stage these in would X. clinical IV Phase I/II patients at nine to having with III We and data exposure benefit disease. Moving Slide dose in erlotinib Almost Pamrevlumab observed like from was metastatic cancer. were advanced only Stage study gemcitabine levels. fact, reference was of evaluated or first-line was therapy. as that the accommodation in metastatic in with XX XX% higher observation the enhanced An locally open-label important drug pancreatic

median from XX% for These levels patients included micrograms cohort of levels was survival. median results had XX% The drug per the also a micrograms important plasma reached overall higher those study most results with higher survival progression-free or XXX for pamrevlumab plasma were improved XXX X-year in lower threshold a of this was patients found. and exposure result ml trough that circulating who Once ml, versus notable of per improved levels. number survival

with pancreatic Slide combination we completion evaluates pamrevlumab The endpoint is Pancreatic trial which to adenocarcinoma. Action is Precision Moving study, adaptive trial survival. gemcitabine first- the the of a centers the trial nab-paclitaxel cancer Network's States. for Precision cancer overall of is late evaluated being arm In with ductal that pancreatic In X. pancreatic the Promise, this metastatic in pamrevlumab disease. II/III treatment primary and January, Phase II/III the metastatic is platform Cancer at registrational patients in phase and announced top for United second-line pamrevlumab being The executed metastatic in the in both Promise study chemotherapy

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PanCAN's enrolled months arm of during X All pamrevlumab upon including in thirteen patients the of analysis patients until last between final two patient period up patients late of treatment, trial X now hundred study. was participated based a Stage to the disease the Monitoring analysis total were pamrevlumab Precision data collected timing Promise experimental completed and all the the for data to results reflecting Precision graduation database statistical and and Pamrevlumab Committee. updated the expect independent is for in complete trial to year. prespecified mid-XXXX, top line meet this its of analysis the report Promise alarm January and in initiated patients X, the XX first progression, the after to arm the The in in subsequent line lock threshold dosed to Stages by the top we is

primary overview of an global to III placebo-controlled of a cancer, trial the unresectable patients pamrevlumab with combination comparing LAPIS Slide double-blind, chemotherapy. pancreatic standard The with we Phase On overall provide in advanced in locally survival. XX, trial, XXX care is endpoint placebo

an of the events pancreatic us accrue events number perspective Since last the required on our is the we monitor lock the the will of trial up-to-date number oncology overall Given the has pace event-driven continually to of we trend common number update, from have most allow ensure LAPIS expect reflecting line in and LAPIS to when of locally unresectable quarter of trial, now database. and the events which and Phase of third study the study. trend III data this events. survival type the of decreased, We occurrence cancer a pamrevlumab in current XXXX, advanced is top in

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cancer On last X There either the Slide clinically limited of pancreatic metastatic a for the review pamrevlumab locally immuno-oncology meaningful opportunity if overall subset for in pamrevlumab we patients. with decades metastatic can assumptions, demonstrate in straightforward opportunity providing metastatic and survival advanced for multibillion-dollar the represents U.S. small patients. Using in or commercial have a it and treatment benefit U.S. diseases in been the a pancreatic locally therapies over addressable to market advanced total cancer. in improvement advances XX, both

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In a with and cancer opportunity survival a patients represent for game-changing could meaningful for prolonging in summary, if pamrevlumab, pancreatic approved, FibroGen. advance

near in results We line expect the top term.

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to showing continues outstanding to the roxadustat of continued growth. Europe addition in In roxadustat in quarter-over-quarter strong China, performance increase. penetration

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FG-XXXX line study Lastly, cancer. in metastatic of top results monotherapy patients Phase we April, announced with prostate castration-resistant I compelling our in from

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you,. Thank

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tumor internalizes castration-resistant antibody FG-XXXX upon and is payload. Moving receptor very tumors, validated but to FDA-approved colorectal ADC a present anti that linked binding XX% is an prostate a other antimitotic MMAE, in a of demonstrates making of is XX% YSX cancer, tissue, which and is binds an ideal in approximately limited that it FG-XXXX to prostate cell types. clinically FG-XXXX ADC expression most XX. normal an cancer CDXX target and to first-in-class candidate. ADC metastatic to Slide target antibody, agent, for comprised

clinical both UCSF. show the preclinical and tumors imaging has FG-XXXX An against we It is XX in and antibody that studies demonstrated biomarker antibody the radio by to constituted PET CDXX positive nucleide, expressing associated same development CDXX XX, and targeting demonstrate is efficacy of YSX uptake has XX, efficacy Slide zirconium the and in clinical cancer. coupled castration-resistant specific cells. FG-XXXX clinical targeting at studies. On utilizes has of preclinical FG-XXXX monotherapy tumor under in metastatic PET demonstrated prostate

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and activity X.X with rate the baseline, and using were endpoints prostate-specific survival for antitumor assessment. trial the tumor median by working prostate population, lines tumor completed disease who efficacy The as and I receiving objective response decline criteria cancer And patients pitot-static of patients of months. five from FG-XXXX. measurable prostate antigen safety, in progression-free The response group the are includes analysis a unselected we radiographic progression-free median total of measured cancer a Phase tolerability therapy received castration-resistant radiographic prior observed a before of XX survival biomarker of

compared other events X.X adverse a size MMAE consistent payload. therapies a least of at acceptable reductions or patients, in XX% body profile with criteria of XX% FG-XXXX those of in observed were of least duration patients. at RECIST an conjugate in with evaluable drug observed tumor of response response anti safety an with For of demonstrated XX% PSA with to partial months. median XX% met reduction the baseline

totality publishing to the Phase I in the of into advance a clinic. further the forward data as in the manuscript program coming months look We we the

in and geographic believe limited MCRPC PFS endpoints clinically shown a not clinically Other PSAXX activity that radiographic versus which has meaningful PSAXX same results early believe have We data, progression-free metastatic meaningful but a signals survival very clinical of X.X cancer. as existing setting. castration-resistant of space mature standard PSAXX survival of such is by objective in encouraged We versus patients for a rate. compelling are in in shown as only care early-stage response and is number these we yet in findings, of other signals, data months and constitutes the endpoint prostate

FG-XXXX a them Moving Clinical also that signaling in XXXX the to at we combination is based portion There [indiscernible] at demonstrating receptor UCSF. from study with the excited X. The sensitizing that to FG-XXXX. dose on remind preclinical combination second-generation to upregulation potentially with this everyone announced Slide interim Society to treatment presentation with is American June Oncology being on tumor selected cells, poster therefore, XX. combination Meeting for for data Annual was that I'm currently escalation of data CDXX the in of trial is a exposure and enzalutamide post rationale run for inhibitor, of

the II of enhance potentially meaningful optimization patients patient and biomarker proper high by dose for trial screening in to derive to therapy are enrichment in likely from target benefits. benefit selection able be FG-XXXX. This Phase a The be is at treatment receive FibroGen. select Also, the with CDXX develop biomarker sponsored our to the of most assay a is clinical UCSF. to trial cancer The and screening will the progress PET with XX monotherapy could for expression part to who patients ensuring prostate radiopharmaceutical goal selection

the with third the registration-enabling upon with design, the study FG-XXXX anticipate II/III on to discuss planning Phase metastatic agreement optimization of castration-resistant are meeting prostate program, trial we quarter FDA we quarter the details of Lastly, the FDA the a reaching initiation the in in a development cancer contingent XXXX. dose in of the and fourth

cancer payload. the look XX. prostate oncology enzalutamide to multiple cancer opportunity pairing studies various castration-resistant with novel efficacy, validated they FG-XXXX, a FG-XXXX not unique potentially with novel opportunity first-in-class safety against Finally, and chemotherapy a in FG-XXXX that prosect shift combination only beyond tumors moving and presents. a presents a novel potential in treatment applications progress. on but represent also other of offer such to an in lines FG-XXXX to paradigm want with summarize cancer colorectal mechanism forward the Slide metastatic action of solid updating offering antibody of potential mechanism and promising We across a FG-XXXX you could action, as types. as cancer. a We target

I to to will call company's Juan? Juan financials. the now discuss turn over the

you, quarter our performance begin Deyaa. to remarks I subsequently for will finally, OpEx for welcome the and the our my and China cash details up of outlook. with FibroGen. China with operations financial with again, XXXX, revenue for XXXX a summary And first business on Thank I will wrap providing quarter results guidance our along

million $XX.X first for million quarter in XX% to the revenue compared of total of XXXX, For year-over-year. $XX.X XXXX, was same increase an period the

to to continued representing of sales The In by versus for $XX.X on of was recognized of to the XXXX, provide recorded Rest volume increase World roxadustat will U.S. last year. driven quarter product I compared to the now was the quarter first net AstraZeneca XXXX, China growth. XXXX. agreement. of million increase Roxadustat development XXXX, of driven in in increase increase $X.X we results, in during QX revenue $X.X an of in are first in delighted due million further we quarter year-over-year. China the total recorded of first the by we net by of compared product $XX.X This strong the this deliver million performance XX% detail continues and revenue XX% a onetime China termination million revenue. revenue and revenue revenue In product drug

have last agreement, development decline that revenue U.S. year. our versus AstraZeneca World XXXX to in the Rest terminated Now of expect we we

$X.X drug XXXX. QX $X.X $XX.X expect forward, product million year. first As during million of to In be revenue to the we compared we we below move XXXX, development of the for quarter million the of revenue quarterly recorded remainder

the $X.X termination Of the partially recent a Astellas, million, drug collaboration Japanese As of by weakening territories, of to million of World Rest products direct our of revenue the our $XX.X with the quarter. driven partner, roxadustat in reduction in AstraZeneca product sold primarily the for yen U.S., we recorded a onetime of result bulk by the offset

detail performance move our now in financial further provide China. will to on I

mentioned value previously total sales increase roxadustat Evrenzo FibroGen of joint first owned entity by As compared China franchise pain, to strong XXXX, the million this distribution of net performance and the $XX.X $XX.X the was an AstraZeneca continued while the by million in in quarter quarter JDE, from or XX% year-over-year, achieving also highlighting of million the the share $XX.X to at roxadustat from our in the price an million the transfer the FibroGen's net China, category. launch sales of highest XX% quarter $XX.X XXXX, sales quarter increase sales JDE from since to first of first XX% year-over-year. From for total compared of was net in

received Net roxadustat in transfer China. of portion of cash price FibroGen's best the is the from reflection

$X.X released deferred also from revenue. we quarter, million this During

$XX.X recorded sales $XX.X GAAP revenue the of to FibroGen and sales net quarter on distributor FibroGen of $X.X result, roxadustat direct a totaling a China, JDE the As to from U.S. million basis. million for from million

highlights Our roxadustat robustness and in and the of adoption physician China. in revenue growth continued patient execution

million to $XXX which reiterating U.S. on to we forecast to China are between full million. a million from $XXX of an in our to range For basis, GAAP be sales net forecast product year underlying $XXX roxadustat FibroGen for XXXX, million revenue assumes China $XXX

part to Operating XXXX, million compared million of the quarter quarter $XX.X million for moving of mentioned $XXX.X the $XX of or World Rest revenue for Cost $XX.X of first U.S. statement. the Now XXXX earlier. the was to quarter related first for were the agreement costs year-over-year. termination of of expenses $XX.X income the debt decrease which and sold the a million XXXX XX% as AstraZeneca recognized includes down million, first of

$XX below Excluding guidance, expenses goods of of onetime our came operating charge, in expense million to quarter. such our cost total for including $XX million operating sold the somewhat

XXXX, well trial quarter in XX% pamrevlumab of million $XX.X million to related in reductions approximately the infrastructure. or support R&D development of roxadustat in expenses X% primarily allocated the $XX.X for directed as activities. our spend compared million was pipeline other Of were our million XX% remaining early-stage first pamrevlumab, first of XXXX a R&D year-over-year, $XX.X expenses, to decrease quarter the R&D towards and reflecting XX% clinical and $XX.X as to

for of primarily million the first XXXX decrease in expenses infrastructure. SG&A million XX.X% $XX.X to leaner in were $XX.X quarter XXXX, driven quarter and year-over-year, a SG&A reduction company's or a the of compared by efforts, the of million first resulting $XX.X cost

During and diluted compared a XXXX, loss basic or $XX.X loss the and net share of first the or basic share a first both quarter quarter we recorded diluted million net loss $X.XX $XX.X per to $X.XX for as of net of of XXXX. million for

the total of We cost forecast expenses, of sold our $XX reiterate operating goods including $XX XXXX. for million second between quarter of to be million to

outcomes of pamrevlumab half by our operating trial XXXX expenses the be the pivotal pancreatic in second cancer. for of determined clinical two will in readouts Our

Now shifting towards cash.

As we and in accounts $XXX.X recorded of XX, cash, million investments cash receivable. March equivalents,

approach, Thank equivalents, be as sufficient maintaining receivable expenses cash, cash plans fund our operating operating and expect in and to our previously you. XXXX. into allocation reduction a communicated, the we With accounts investments disciplined to capital

over would the I Thane. now And to call like turn to back

expect Thank you, In value Deyaa Juan, line potential for top we pivotal updates. financial we pamrevlumab clinical excited two prospects the and the from recap, To to near-term data studies. your they and following provide and closing, stakeholders. about are our

trial locally the Our our And metastatic and of III the quarter continues half pancreatic this with LAPIS chemotherapy-induced approval in cancer Phase in in in for sNDA well markets. third Precision II/III trial an other Roxadustat Phase where network in the year, of second roxadustat and mid-XXXX. China of anemia decision commercialization action advanced partner Japan in expect continues Europe, of very pancreatic XXXX. cancer we the pancreatic Promise ourselves indication in cancer our perform to

castration-resistant regain AC lower-risk to our been metastatic an the roxadustat patients anemia prostate pipeline, rights totality monotherapy Phase MDS. for top compelling territories in from line and the upcoming and in data reported recently With exploring with from study excited manuscript. early-stage cancer publish Phase are opportunities I will I for in in FG-XXXX we partnering U.S. ROW of we the data of Additionally, have potential

the Ib data of Annual FG-XXXX be We monotherapy initiation American Phase our anti-CCRX study of filing our will dose our Meeting June. second IND of Phase II FG-XXXX presenting anticipate anticipate escalation in of with from antibody FDA dose antibody of in anticipate our an enzalutamide We near Clinical term. XXXX. study in clearance We for XXXX XXXX. at and the and top line in anti-galanin IND the of Oncology optimization in in MCRPC the in we MCRPC FG-XXXX, combination FG-XXXX, for Society half

a strong said, into as fund balance position, operations expect and Juan Additionally, have our to sheet current we cash XXXX.

In thank roxadustat would priorities to against in more we continue strategic the turn our and I employees I now call the of like Q&A. to to all pipeline summary, will strive to their sheet. operator few strong like over for balance for hard would over resilience and last the FibroGen our current our work pancreatic cancer, to the we continued months. near-term attain believe reflective we readouts as of is valuation revenue future that and oncology our pamrevlumab a execute stream,

William question from first Our [Operator Instructions] Andy Hsieh Blair. comes with

Congratulations on the progress.

as pretty What's you and is I'm intrigued There jumping you follow-up. Can of comment guess, Could factors on ones, third study. as share. to of value mentioned, is the the up us kind that I quick is? you in uptick the roxadustat. that explain have your a two readout to why slowing So market rates event uptake? about of why nice quarter uptick, terms I the by leading also driving in you XX%, educate and wrap back to a LAPIS

questions. Yes. your Andy, for thanks

event and just these the accrue OS are events. patients who there where remaining events. alive we number thankfully, a fewer need a that a rate, power that the that are trial, accrued patients. you additional with are number it's fewer We articulated last And of LAPIS the to but had accrue prespecified the number there where enrolled of in slowing OS that's OS so still patients patients events XXX to the of to are, of On then as accrue hit OS and There to certain math. SAP be are we our really events, part

any in And trial an just trial type. occurrence event-driven common this event-driven oncology of is this a or

events we keep trend we earlier then be we're but to updated then once number, and of -- lock -- reach week the We're opposed we of expect to and number events. looking that the continue close us number the once we getting I event last you recent allow reflect prepared to wanted the remarks, we OS to update results. like sense? said, top database, anticipate And we rates. just so most perform time in say QX of we'll that to to in then QX, on was that said, release every sometime And receive line QX, analysis prespecified in OS to that our the power would prespecified that will that to at to as remarks the it which that be QX. as Does in the very make reach the

Yes, that's very helpful.

addition, team. over XX% to And share the in I'll continued and FibroGen value AZ with Okay. to comments. it then to Bina for excellent the roxadustat for -- China respect turn some additional Chris execution by the obviously,

local group we forces X%. about cuts team optimistic are the really seeing One factors for experienced that NRDL any There outlook. look this Andy, that we in can is up. all two market in fundamental changes is not price the

in believe you sensitivity, helped might have that price little if a bit. So

a class. is installed introduction second of became push The the second And factor we a is for bit we new a have of the of which [indiscernible], the that, base. think an entrant hip because little

strong very very, it not outlook, but market the believe in reflects we this change force. market remain little bit. the helped force. overall, a a We outlook in optimistic us any have we fundamental sales do actually But about think We

And experience since performing like I base it And momentum think, like provides of a Andy, for and installed gets role once patients prescribers, that on it momentum this the you because and China, you installed has establish base is positive that done roxadustat this it's on -- like create launched. it patients this and of been really reason of clinicians. the in is it's

And the extremely self-perpetuating of level. a at to so well it's just that the continue just we drug see because to patient expect almost set performs momentum

options there Jumping PARPs. it. out across XXXX, to I the Got for guess the looking guess, I is it. That's Most Got prostate helpful. of cancer. exception paradigm of the monotherapy, with

the of your there or As based what the are reduction, Is success PSAXX Just to [ of a for response doublet on you KOLs, looking ], our XXXX into rate like think enzalutamide PFS bar plus the for? kind in heading about discussions terms ASCO of kind expectations combination RECIST? with they set readout. up in the

question, great turn his to for Andy. Deyaa going I'm it to a thoughts. over Yes.It's

Thank answer. the me let you question. So for

with study First MCRPC from in include paradigm. dose all, and it and setting escalation first prior will combination patient to in populations receiving of the docetaxel the second-line a it's enzalutamide,

prove we patients said that, looking having exposed previously are that to to ARSIs been truly are here overexpressing second-generation have hypothesis CDXX. who the So

the of this So is. what is objective trial the

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of Jason Bank from Gerberry comes question Next America. with .

on on quarter. the is progress Jason. for this Congrats This Dina

Like just data half I this the Could on second with because that supplement there II FDA the of year? the the kind dose for you're Phase you're optimization of trial. us FG-XXXX. explain Phase of ahead from like it you reason one on Just this Phase more study necessary sounds initiating II is meeting the in to planning optimization launching dose

will it inform Phase your So just trial? curious II/III how registrational

question, really Dina. a Thanks It's good for Yes. that.

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Thane. you, Thank

in Project your component design Phase offer the patients that grows forward recommended lowest III that that across have will benefit this question, maximum dose the with of purpose has be is later dose. terms the identified adverse of answer in board further II the initiated So development having of XXXX, risk Optimus you Phase essentially, the is to it drug sponsors this dose in to Phase clinical will FDA right backwards if And II/III ensure the and the on moving optimize the called to events. go

the So the the dose we trial. requirements Phase are to III optimize FDA registration essentially complying start with before we

our this So optimization. about dose thinking is

Dina, also plan the the addition and to articulated, one with this response biomarker all optimization to FDA, Deyaa again, with dose is on, as patients post of And final to hoc a correlation and plan the treating concordance the on analysis comment, doing we then PETXX then well pending what ADC. expression CDXX in in phase assess the

the And that's optimization design. part important the component of of so an dose also ongoing

comes Choi with question next Our from Sachs. Paul . Goldman

the to dose with the monotherapy question Just prior to on regard II follow Phase up optimization.

curious to dose doses that Phase time China. line in XXXX. time II your just able anything question in if you particularly for if the . My that the accelerate second at Evrenzo of Your data to insight from be line optimization. calls monotherapy for -- regard portion, there's I'm might potentially in just terms is higher with the

calendar NRDL no But half year. timing updated would this than your of for for second for CIA maintained inclusion confirm XXXX. the just the in expectation to be your You've for earlier indication

If that, would you be that could confirm great.

Thanks, Paul.

design that time more step Regarding we will we've now the we've and back XXXX for done that line thinking FG-XXXX, a kind discuss FDA. Phase around of the that this a lot taken proposed with II/III the

bit the would totality a probably to see It's data about optimization set. when dose premature we talk that of

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possibly Deyaa, to so get as plan add our And would you that? quickly to would as be execution can. to anything we

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then I'll timing updated Great. the on CIA guidance. to Paul, comment And ask Chris

the of of projected So timing frame review the at based the updated Paul, filing. current time of on the approval the CD technical the we progress

projecting are a XXXX. second We half

need mean not Although we your right that in answer specific yes. reimbursement not half. To qualify indication comment second review to starting January that a have But the XXXX, to regulatory answer be January now, The to process. be moved it the for XX. XXXX approved would by for in of XXXX. position June we would is on conservative, for to we question, us to X, we're CIA X, NRDL would order until

Yes.

timing able approval have hit inclusion that very believe team the the to a there's a we'll right? our important to closely still CIA point this Paul, to we And It's be so that please handicap allow for at really work goal chance on would with not whether time in achieve just us. But it's know CDE deal us the in XXXX, that the or do to to the indication premature review. continues to be And for so in able that.

over I closing Thane Wettig would to turn now for like back call the any to remarks.

your Enjoy interest and day. the Yes, you your appreciate we FibroGen, for call today's in of rest questions. participation investor your thank continued in the guys, and

for Thank you. This your participation. concludes Thank you conference. the

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