FibroGen (FGEN) 8 May 232023 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to FibroGen's First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

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

Thank you, Relations good of Eleanor, and Corporate Vice Michael Strategy President Tung, and Investor at afternoon FibroGen. everyone. I'm

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

AstraZeneca The the but prepared forward-looking limited and guidance, and to Juan results include made format regulatory activities; are our not to remarks matters. from enrollment, our the clinical after, results other which certain remarks research Astella’s today's call strategies and and include our call of for includes collaborations risks financial business Q&A. our initiation, statements development of results; like Enrique about we with call would that related today's conduct and will design, to I FibroGen. operations; you business open trials; Such and remind on results may for commercial statements potential regulatory and

XX-Q. FibroGen found is statements undertake result the filings forward-looking with future new events in more could a uncertainties events risks not SEC including and to actual our does FibroGen's of or Form Form results obligation of these in those cause description publicly complete risks and as statement recent to most any whether any and be update that material otherwise. forward-looking to Each information XX-K can from subject materially A differ that projected statement. other and

be of call results Investors our update and reporting FibroGen's and website can a release today's webcast on business www.fibrorgen.com. of section press the at financial conference found The

would like call over I the to Enrique Conterno, CEO. our turn Enrique? With to that,

summary afternoon On Mike, and will call after of we and call will I'll good. you, to in thus financials, a for then call. review far Juan earnings good CFO provide today's questions. first the developments XXXX. quarter through our the your everyone XXXX welcome Very important open and Thank Graham, our which accomplishments

Starting to unresectable areas first, for Phase in executing focus; pancreatic positioned delivering by is value dystrophy, X idiopathic advanced X. with muscular create shareholders three and three cancer. of pamrevlumab patients pulmonary pivotal on indications; slide and high-value fibrosis, Duchenne FibroGen locally data significant

our for increasing by innovation productivity novel leverage expertise opportunities. additional research that internal Second, advancing and access pipeline programs external

continuing roxadustat in commercial ensuring patients third, China. approved, with chemotherapy-induced anemia chronic where in of studies while the And the success kidney disease

catalyst third Moving FibroGen slide scenarios, expeditiously top outcome deliver of an these on data and include trials an and mid-XXXX. are X. filings represents trial for additional ultimately to launches we Operationally, from two various therapies by exciting quarter clinical year well-prepared to through could multiple X Phase the line patients. rich regulatory expected this which opportunity four with to

two progressing we addition, In preclinical to are including potentially near up INDs year-end filing pipeline XXXX. our

focus our strong financial steps discipline. have position our We continue to taken financial and augment on

line data top the treatment syndromes clinical lower-risk to or for of On study from patients myelodysplastic roxadustat transfusion-dependent in announced May anemia Xth, Phase on X. MATTERHORN Moving with we MDS. slide X of

roxadustat who placebo did achieved of XX.X% with weeks endpoints. meet of proportion primary arm the was p-value the transfusion The to not XX a independence study its XX.X% for first compared X.XXX. Towards disappointment, blood efficacy patients in red the cell for

be findings. Safety was roxadustat consistent will with preliminary profile further The was observed analysis study adverse event safety completion. or at evaluated previous in the generally that

line roxadustat, of data study with shortly. anemia anticipate Now at Phase in top we Slide X China let's clinical time a to patients Starting move Slide our on from trial X chemotherapy-induced bottom X. with lines the

Track Fast remind dystrophy lives and to want both muscular improve significant pancreatic potential idiopathic of FDA and of Disease Designations duchenne represent FDA diseases the fibrosis, and indications unmet are the with locally opportunities Moving now I unresectable to developments. Phase all Pamrevlumab. meaningful pulmonary in to medical needs that X Orphan advanced everybody three for have patients. cancer we each

line Moving in chronologically, non-ambulatory ZEPHYRUS-X, third Phase study XXXX. ambulatory in from with we LELANTOS-X, Topline in DMD LELANTOS-X trial from data in expect mid-XXXX. quarter in the second from our of X in top of DMD data XXXX. Topline pamrevlumab of X Phase the the quarter data our trial patients the IPF

XXXX. of from in in patient XXXX for of in the out X LAPIS next mid-XXXX. Phase quarter the is which with top study first first line cancer year, Phase locally data the ZEPHYRUS-X, line data IPF, completed expected the Looking pancreatic from expected in Top half unresectable trial advanced X enrollment

not pancreatic Precision Finally, slide, of networks cancer with adaptive platform, to Promise with evaluating the metastatic trial in although cancer the pamrevlumab care patients pancreatic progress. on action standard for combination continues

pamrevlumab the organs. LAPC A DMD fibrosis, pathophysiology diseases, with we read-through and common any unique is different there's very three each trials. common a feature question of receive different are affecting but through all a IPF, across with whether

tissue a IPF, rare characterized in the fibrosis disease damage. an the progressive In which indication by in LAPC oncology muscles. lung irreversible associated fibrosis key pediatric the causes and genetic disease. in fibrosis feature tumor is is a DMD of is

conditions pathology, no of these we disease efficacy to in is believe or differences there read-through from limited another. one these Given

to and the FibroGen my gratitude in I has transformational year for we patients to as adverse like a dosed to investigators, will for pamrevlumab years. colleagues patients, of forward FibroGen. sharing in studies. seven caregivers for well side, have be who And including X,XXX my XXXX studied favorable over look a patients the and has to safety as the results their to up and been been On profile, commitment. extend these would safety event demonstrated

our our Japan, opportunity as IPF China IPF billion $X significant revenue a net a I'd over approved commercial IPF we opportunity two pamrevlumab, Slide generated prevalence across XXX,XXX together monoclonal the the spend view now opportunity, with with of few approximately current large growing patients a diagnosed and therapies in highlighting US, of detailed global antibody. significant like represents X XXXX. the of minutes to the see in EU, and a wholly-owned commercial provides perspective

Despite remains of important the are characterized with approved continued progression IPF need challenging tolerability. which the there growth by medical and unmet size disease and therapies market, antifibrotic the

treatment There a current is become sentiment in believe the community IPF. IPF product limitations therapies to has we potential patients for number with and of a of the sizable the and pamrevlumab the of relevant help

slide where lung high function the morbidity tissue and fibrosis progressive in that loss lung from benefit patients new As IPF to we reversible resulting options. mortality. of we highlight on a disease in IPF eight, believe is could therapeutic leads

median diagnosis In only is years. fact of survival following IPF five three to

the slide are of treatment rate as depicted progressive of on limitations modest The side options with profile. loss current characterized of along challenging effect function, lung right This translates low tolerability on the having slowing eight. a a into treatment well a

In the with year. XXX,XXX prevalence estimate XX,XXX Of US, a there patients these with that diagnosed antifibrotic. patients of only is patients newly IPF patients about we each approximately with diagnosed third a are treated these approximately XX,XXX of

severe and for usually in US two of results being this diarrhea, Of approximately start antifibrotics the of XX IPF treatment patients include treated due in months progressive side a fatal to the and XX photosensitivity. which one discontinue year, diagnosed a this This in condition. nausea, XX,XXX effects not that to roughly large given first patients XX approved proportion

unmet and of due our has treatment likelihood with to believe including challenging treated Because to confidence antifibrotic current diagnosed patients stopped to our to Phase pamrevlumab been significant this have who success X an IPF be on patients optimism program. not those the options our need, reiterate and I PRAISE want the patients, of result antifibrotics, of tolerability. ZEPHYRUS important in potential we have existing the treatment addition newly who

left to with locally to column. help advanced Both and Duchenne significant muscular nine. Moving pancreatic in represents cancer DMD unresectable Beginning slide meaningfully patients. dystrophy opportunities the

relentless Given therapy. disease, nature of the and the LELANTOS can the program of devastating needed lead the definitely a hopeful that approved DMD Phase are to X we progression

have they the meaningful produced dystrophin targeting for yet muscle improve skipping therapies proportion progression. automate the currently increase improvement downstream of approved [ph] by exon a changes There and demonstrate clear to disease that only can pathological an or function. a clinical disease symptoms a need to in While DMD small is progression therapy in levels patients DMD target

mechanism pamrevlumab families. We and may are a the be antifibrotic hopeful treatment these their patients of that help can

and XX patients DMD the we upper elbow and non-ambulatory more shoulder advanced top quarter. data primary expect endpoint measures and this wrist enrolled older the The disease. line hand performance the years which functionality of LELANTOS-X with limb of is tests

this we old LELANTOS-X Assessment six which endpoint expect patients data of Star enrolled ambulatory to third less quarter the year. the of function a measure is disease. with ambulatory in XX and Ambulatory North primary DMD years is topline The advanced

right-hand represents snapshot locally diagnosed largest opportunity. patients five-year over major approximately pancreatic cancer of regions one prevalence In across a survival XX%. low advanced XX,XXX the cancer disease-free with the a we show needs rate the a unmet column, the and of Pancreatic combined in of oncology of

and we the believe been evaluating the stroma is survival both significant this with to survival. pamrevlumab meaningful potential if advances have effects treatment direct We limited are cancer. metastatic antitumor and effects on had pamrevlumab over LAPC that why and both pancreatic failing improvement two a current can overall demonstrate over opportunity therapies in demonstrate This last commercial a benefits creates immunooncology we the for decades standard-of-care. There

LAPIS study first half in line XXXX. top our We expect of data the from

I want XX. take our to comment early moment Slide Moving on on a do stage to and pipeline.

solid progression directly its expect preclinical end antitumor near characterization and T in leukemia, death reverse this GalX-mediated many leukemic acute that cell antibody for cancer is immune of developed shown to target for year. AML. in tumors immune cell two are cell FG-XXXX myeloid up FG-XXXX undergoing subtypes the file We inhibit ability is has and target-driven responses been to to anti-GalX prevent INDs of populations. to resistance to an critical

FG-XXXX and immune death deplete antibody regulatory broad selectively tumor anti-CCRX an is affecting T in designed to induce without cell homeostasis. peripheral cells cells. tumor reg micro of disrupting activate without the tumors has FG-XXXX in potential environment T responses normal Use to solid suppressive immune

in development leverage expertise our we have biology. addition, preclinical In CTGF undisclosed which and HIF programs,

XX. we Moving for Today announced license into to with FibroGen Fortis Therapeutics exclusive the enter an Slide FORXX.

most and FORXX targets tissues. on which in CDXX, on Fortis' antibody epitope present This normal cancers, prostate a is including but cells, conjugate lead drug drug first-in-class novel cancer certain candidate absent a potential opportunity. colorectal represents

is and FORXX the X Phase cancer for development other treatment metastatic castration-resistant cancers. of CDXX in expressing currently prostate

the continue develop selection. a part biomarker a FibroGen the clinical of strategy, As of to utilizing radio-labeled development will version patient targeting for antibody PET-based

and Under of the FibroGen FORXX PETXX. conduct future fund development and there no terms of research, is will the upfront agreement, and consideration. manufacturing

option $XX for four-year during the acquire have the million. to evaluation period We Fortis

Moving now grow nicely to Slide China. in to XX. Roxadustat continues

compared million roxadustat FibroGen owned $XX.X jointly XXXX, the China sales total of to quarter by by over of million entity growth net in in $XX.X FibroGen quarter increase volume distribution of driven increase by an First XX%. AstraZeneca an and XX%. first This the was and in was

for financial net first in XXXX U.S. in Juan roxadustat update. was of GAAP the China product portion FibroGen's $XX.X on will revenue quarter a provide detail more million basis. of the

over CFO, I for our call Juan update. will to financial Juan? now Graham turn the this

Enrique. note many you, started XXXX on a strong on Thank has fronts.

Our pamrevlumab in for trials continues have a EVRENZO our to clinical enrolled. strong at perform pace. franchise been China and All roxadustat Phase X

early is early-stage Our members. these work are of want And elongating time None and I the our funding the of without so efforts us and continue recognize to our pipeline while take to to hard enabling advancing. achievements this this team our year. our happens leadership dedication growing in runway. operations financing

the we about quarter our path this by As ahead we more out year optimistic We're two pivotal forward. both through clinical third look four and trials reading and of have excited mid-XXXX.

Moving into financial our results.

revenue that approval to regulatory $XX.X total period million $XX million the $XX.X compared Russian to of EVRENZO Federation. or worth For the XXXX prior received XXXX. year includes first was for a due in same roxadustat in payment noting of comparator, million is the quarter onetime It a

an of to sales increase As of of compared $XX.X first year-over-year. net roxadustat We in $X.X QX This recorded in XXXX. XX% million the revenue is follows: quarter or million XXXX of sources $XX.X revenue product for breakdown represents the China of as million

quarter development associated quarter efforts million revenue of partners $X.X the XXXX. with roxadustat recorded co-development as of compared first for $XX also our to million the we During with during

be stated, revenue expect to previously the million to $X of for we of XXXX. to per development million range quarter we roxadustat the with partners stage As due co-development $X our in of

from payments We program also associated million of our milestone license revenue recorded the $X with cornea biosynthetic with Eluminex.

US that related million recorded GAAP. as first active Comparatively shipment made in And to finally change XXXX for sold we drug in Astellas quarter shipments per related these a roxadustat product primarily our $X.X product based product of estimates bulk pharmaceutical to revenue revenue $X.X in or during on the ingredients was the to drug the quarter. million drug

commentary owned from financial the a or the roxadustat Further in China. of million and distribution in was sales Total joint for by year-over-year first of $XX.X net performance franchise as is the the XXXX quarter AstraZeneca FibroGen this China $XX.X in million performance strong follows. roxadustat increase JDE XX% compared substantial entity jointly highlighting quarter of to EVRENZO

net sales from sales roxadustat JDE China net for was in total FibroGen's $XX.X the transfer price quarter. to million From the first

quarter this due as our from to million in $X.X change previously recorded balance we GAAP. During future an additional the per estimates deferred the U.S.

FibroGen the revenue and $XX.X result million $X.X net in JDE to roxadustat sales China. direct for quarter a recorded FibroGen the of sales As for million to from distributor

statement. income the down Moving

in associated pamrevlumab million with for XXXX were $XX.X million $XX.X $XX.X million for our reduction XXXX. clinical $XX of first to trial the of expenses was quarter R&D lower expenses programs. quarter to year-over-year. to first first compared lower million XXXX R&D supply operating expenses a of compared $XXX.X million The for were $XXX.X Our of costs million and quarter to reduction quarter first due costs drug of the and the XXXX related costs the

allocated the first development pipeline US Of $XX.X pamrevlumab activities development to CMC our quarter spent XX% XX% roxadustat to roughly and in directed China. dedicated XX% million remaining towards in the activities early-stage and the the and support was

were of first representing in $XX.X driven expenses. compared a other $XX.X by employee-related increase quarter expenses XXXX, to million XX% quarter SG&A for first primarily XXXX the and costs year-over-year the of million

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

structured make to Morgan million reference our with Value events. completed to tranche of funded. million. for X initial financing Tactical Stanley $XXX been efforts $XX XX, Slide to loan financing May I we With reference regards a on I make want On that to up agreement The has

The second third development certain upon of million will of in of funded $XX.X quarter clinical XXXX achievement be milestones. the tranche

up option has to in Tactical Stanley million Morgan third of to the Finally a $XX.X Value the fund XXXX. quarter of third tranche

participation proceeds Secondly, QX, accessed during subsequent long-term million $XX.X to of investors. facility high-quality net and of we focused our ATM existing with raising

sheet, our the pre-commercialization pivotal pipeline. our of and all R&D operating pamrevlumab data In these plan balance addition Phase support and to X including expansion initial strengthening of financing advancement roxadustat events funding readouts, pamrevlumab our activities and

allocation to receivable. which financing $XX.X and reported through through capital With be we efforts now to investments a our our equivalents cash XX. XX Moving proceeds At operating cash in Slide approach, equivalents of current cash, and million $XXX.X fund cash, includes net plans our we ATM sufficient disciplined investments and accounts million receivable accounts facility, our to expect maintaining March XXXX. raised

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

I XXXX. like confidence through to reiterate closing, In Juan. as we you, our progress Thank would

X line top Phase shortly. expect anemia from pivotal roxadustat in study data We chemotherapy-induced China

three expect XXXX. through in in studies patients LELANTOS-X data We third patients pivotal XXXX. pamrevlumab for Phase of of second quarter LELANTOS-X the DMD XXXX, ZEPHYRUS-X IPF with quarter non-ambulatory from DMD ambulatory with of third in the the patients in midyear in and X quarter

also two to XXXX the INDs The FG-XXXX FG-XXXX, focus Roxadustat oncology. to Europe properly roxadustat through operating we X both very our financed Stage additional and clinical file believe anti-CCRX cash we antibody our XXXX. continues bolsters and for oncology. antibody the Astellas and pamrevlumab Fortis pipeline continues and well through perform near line early to we expect key able to in transaction early the up and financing our in expect In year-end After data its releases Japan. our are plans in commercialization partner China we of to top in be initiatives, with and our fund anti-GalX

Eleanor like now our for operator Q&A. would to I turn over it to

time session. this At conduct Jason [Operator of Our Thank question comes Bank the America. the line of you. Gerberry of from first we Instructions] question-and-answer will

Your line is now open.

my for for Thanks couple guys. Hey, A me. questions. taking

PRAISE on pamrev for your Xb study question Phase IPF. Just a

primary actually the final the of proportion received at assessment XX observational SEC due could On patients of the analysis What dropped week characterize their the who XX study patients per to discontinuation? you efficacy out analysis? those

do the mid-May missed top-line when to doing lastly or then And refined have know it on any you this before I you X data mid-August. was other And care Phase ZEPHYRUS-X? but may plan an ZEPHYRUS-X I you about? observation-only regulators sensitivity that then basis, your results, analyses provide for range you on will the if

time if range? Just wondering refined that you

question. you thank these if Eisner for Dr. of -- and very questions Jason, some your good. this questions going to address I'll have much your I'm respond necessary. Very to complement

It's Thanks, speaking. Mark Yes. Jason.

So many contributed all analyzed visits didn't complete for so was week earlier there the up PRAISE you study to of all study. patients the The data and intention as study XX completed treat FVC used available analysis. who of by mentioned the some to to follow-up points time the were were But data XX. those in

of to terms will the test on from just practice what the with we sensitivity robustness methods analysis of will you standard provide Enrique, ZEPHYRUS-X of a analytic and aligning FDA variety course look on question. the we're the those analyses and the like. primary In results data as the to a top-line used back maybe of

Yes. Thank you, Mark.

there's think -- I was midyear additional question on refinement that estimate have. On whether the your the we

readout. midyear. look right are to for we the basically continuing at It's I this on think midyear

the characterization so And that we are with sticking timing. of

guys. Thanks, Okay.

question, One our for next question. next please. you. Please for standby our moment Thank

Blair. question next line the of from of comes Our Hsieh Andy William

Your line is now open.

questions. my taking for Thanks Hi.

my for excuse voice. so cold a from recovering Sorry,

for with don't think do One treatment? Two eligible question of mind. if will you what is proportion has patients you First [indiscernible]. to parters, be the do

the used what of number And what's for in the portion will plan radionuclide study or question And number for sponsor is imaging procuring metastatic a we any be procure about in second two, if it part, pancreatic the -- X.X basically stream think little investigator plans one. Question the of to just the for is stringent? development that's interim efficacy plan? there analysis? cancer. your so bit how an Is should more HR And

Andy. question good. I'll and the address I Hunter address metastatic John Thank on your you, trial. then Very FORXX have have Eisner Mark cancer the question on will

up a questions. Andy. broke Hi, Thanks the for little bit. It

to I me. veer a So expect biomarker start set but very this to-date who be the based please with say if seen from of we have point. on of to for only imaging patients we percentage to work in we correct terms it question But away we've the with data eligible over would would small XX%, be what at FORXX

refine hoping we're and the the it the... regards through with trial to as analysis also just get PET to patients get imaging And So more as then, online. we we

radionuclide for agent. the about imaging the we're Yes, curious used

So the using is and is yes, XX right clinical imaging. that now, I for zirconium the the imaging, what's plan worked believe they're being up for that --

address Precision you question And trial? could Mark, the if Promise the on

Sure.

versus one from So pamrevlumab on is There criteria. of conducted metastatic which a graduation stage X for of pancreatic futility is stage stage stage were X. and X the of on then pre-specified are a chemotherapy stage X, backbone there the placebo to two a trial and based top on series Precision Promise analysis stages; there cancer,

because unblinded study are is generally we is study design, by being further any by the the the because and to because not information, study conducted is PanCAN. Now ongoing its privy

that's can now about we status say the the So trial. of about right all

Okay. Great. Thanks.

Mark. you, Thank

for question. our Please you. Thank hold next

of comes James. Danielle from Our Brill next line the of question Raymond

now Your line open. is

the pamrevlumab. have evening. Thanks to relating question. couple Hey, guys. I Good for a

I combo? also is you thinking for assumptions First, combo should the or in about ZEPHYRUS-X? you terms your if reminder more then more Thank what also will standard with curious And you. us of one is that unlikely of in but expect to generate we that your consider just PAM we And data care? know these the in incrementally are then efficacy? discontinuation set I need, how would in complementary tolerability limited, curious rates remind it what be combination be I'm can therapies, should

I'm I'll Danielle, Yes. his have you. Very going good. address question of your to Thank Mark complement some answers. and

Sure. Thanks, Danielle.

So, necessary of if are ZEPHYRUS trials start just that standard the starts, study background placebo, monotherapy trial therapy. background naive. study. care patient be or versus of the care can on any when to to of pamrevlumab to remind patients they're treatment not either it other They be the experienced therapy, are physician But allowed treatment taking the on everyone deems

formal of versus difference of will of of the won't not and design really of we trial. Esbriet So, Ofev have they've for placebo seen those really That's standard alone. we in have pivotal test top the care But pamrevlumab care standard placebo-corrected of PAM versus versus on trials. indirect comparisons what our a

did tolerability, of PRAISE safety primarily or have PAM to that a we well small terms either and combination adding was of In Ofev looked arm tolerated. Esbriet

issues tolerability anticipating not there. we're So

and them use specific very monotherapy design they combination as would fit. be will And we're who could speaking you of in if clear understanding set label data be the then from to physicians go to very, have. more our we patients what see generate monotherapy to detail that But finally is the like, a that, take enable pamrevlumab to we IPF going into the this for in as care or

the So question. part that's of your first

question discontinuation for rates of to your has part second the The ZEPHYRUS-X. do projected with

for all big but and every both pleased We with haven't We're how been on disclosed going. making patients effort XXX focus that's to this for study. keep XXX. we're us publicly, a very and It's

So the robust at we the of data a are very end anticipating set study.

Great. Thank you.

Mark. you, Thank

Please hold One our for next question. moment Thank please. you.

Paul Our question Goldman Choi line of the next of Sachs. from comes

now is line open. Your

Two please. Hi. Good our for thank us, afternoon and you taking question. from

stated PRAISE should study. that file IPF you succeed based on that could believe [indiscernible] previously ZEPHYRUS-X study the that First, past Enrique, you in think the I you've that plus

terms on of regulatory of us remind previous gotten terms Is in your agency what in something point? this you've interactions? discussions Can your that said have written confirmation you the from

good question. Yeah,

Just recap. to

with ZEPHYRUS-X's results to ZEPHYRUS-X believe us that a we is utilizing FDA in said position have we to in I the for will be if that those have results. replicate we file to were order to think we discussions able good PRAISE, be what that, the

add results yes think this alignment I moment the type Clearly, point can be very we any a us. to or of confirmation have those think until PRAISE that for don't we from we could that. results, in get I will time And exciting I FDA. the At think

Got Juan, Okay. is question My cash guidance is of it. the Thanks assume through from that. financing exclusive additional for Does statement for just tranches the tranches? your on recent second XXXX. there runway your additional or two that with those MSTV,

Yeah, for basically the upon the contingent MSTV deal, thanks And financing guidance achieved. tranche includes or I the question. the cash Paul. Hi. rest for being that the certain clearly the are mentioned basically milestones initial initial

Yeah.

I that cash mentioned, in including MSTV, are from not And and our more that, And we of projecting investment as second particularly Juan will larger think we but understand million are plus or XXXX. runway, we about the runway that part first needs Paul the our to as the it's have one one. think as this important $XX studies. positive therefore, tranche,

Got it.

back Thank in very much. I'll Okay. you queue. hop

One question. for next you. our please moment Thank

line Our next Yee of of question comes Jefferies. Michael from the

is line now open. Your

guys. afternoon. me? Can Hey hear you Good

can. We

questions, Good. quick thanks. Two

there some questions dropouts. statistical First earlier were on estimates pamrevlumab, about methods and I know and

XX% completed XX% various or some looked imputation, people know that use that say, you study people have of let's there's versus just investor around really in Can of the the people, for at of fully the of the XX% around fears questions the the investors comment that data just those I actually the of XX% estimates strength but been of dropped estimates that or the on consternation data. of that the and out

that estimates or imputation about you're using And the comment about how feel So maybe just whether you in that. X? Phase and

us And milestones related that is for a these two you based specifically data little question are help studies, actually out to second some on bit in you. know comment? of positive that there two maybe just you I optionality. follow-up and different a then just having or my financing. Is Can on tranches tranches. Thank the fill the that mentioned

second question and that Very forth? the and question. patients good. this address on first address provide XX about discontinued color will whether so question question feedback you from Mark and could please your PAM your some on about additional investors Juan the you can Mark,

Sure.

there's in contribute data. the think I XX unfortunately propagated a that So didn't patients out who and dropped that's misunderstanding been they about early any

it was analyzed intention was PRAISE way to treat. the So

all So were the they provided. included terms in patients data of

for a will study baseline out their data week dropped So, well simply XX severely an until week week estimates. all XX the if those out was in throws analysis used. XX, and incorrect example, have patient And week patients and at just week that XX, been would XX up be biased provide

I you disease So you're counted a with You is check you what early, progressor. analyzed think just as or look death. of I right? out saying, approach. decline responder a are they're if trials want I'm counted And definition you And gut which more how to intention or can or either at mean I endpoint if that predicted drop we you a have don't clinical FVC if you're agree analyzed, to according that's problem. avoid think to look don't. And progression rate, typically you XX% percent treat to that of the at as of progress kind

that So require any doesn't simple way allows of into patients that it a very analysis statistical methodology. the fancy incorporating really

think up, time on that in analyzing patient points data, include have we we analysis standard all So data which similar all of the sum And just that at PRAISE the the way that our will points. FVC it something of done the to is be to followed ZEPHYRUS.

data are response. a favorable that at with the for rather actually imputed If they along the the dropouts view were kind I do included actually estimates the dropout included may imputed when of but than a could with not And all. included or drive supplement that estimated growing the estimates ask is I more follow-up, data that that the the That's thing?

So, analysis. that's the for the efficacy there done think was they again, at XX I patients imputation dropped a primary no misunderstanding. endpoint point out, The

then Got it, financing? And okay. the

Yes. Hey, Juan. Michael this is

think I question point, third is your related your Specifically second to tranche. and

upsizing the second tranche basically available be million of over would certain development milestones an meeting the XXXX. endpoints that $XX.X upon On clinical of or is course

well are discretion disclosed has of those other Stanley clinical haven't as tranche this new Morgan milestones at to their We million then is items. Value such and upsize basically up Tactical $XX.X what or point? again to at upsize with this basically no a And any the third option

Got you. Thank it.

Thank our you. please. moment next One for question

question Annabel Samimy line Our Stifel. of from comes next the of

now is line Your open.

PAM the talk questions, any I current to PAM of further capacity. or Hi. differentiate exploring exacerbations on additional care standard worsening maybe of that for taking a be about to few have Thanks total time can could I lung you that from going secondary clinical and you're first, like my for endpoints IPF. guess, or

in crowd? a has to you're scenario in PAM Just where event safety, better but of efficacy maybe from trying the separate sort equivalent the

study, following mentioned you on And know patients I could while then that just not up some from be earlier they're the but some offered in questions. standard-of-care, of care. starting standard

for efficacy when know you will going safety, on disclosing you done. it? standard-of-care? but you. is treating wonder said data combination of And I that any it details So, guess, I how was have you're any the Thank all of to you data? and And have and any be be do I that do further PAM

you have two questions. I'll Mark, PAM address the

Sure, absolutely.

pamrevlumab. with I profile analysis and agree we efficacy So to meaningful important do endpoint delineate important progression be think disease or efficacy the with to a secondary clinically And FVC One decline the of will the this is clinicians is going pamrevlumab. for you, for first of because be XX% efficacy, this question to secondary death, full has patients. endpoints

exacerbation or time time hospitalizations to and IPF as or progression, centrally to death for have do disease we hospitalization which exacerbation. is IPF defined adjudicate and IPF We the

be rigorously cap endpoints those have try although, efficacy We're have numbers the also they sufficient we'll fully fibrosis lung to well the full to going of should score. a of trials are defined. to course, And statistical in not variety of secondary But have out have IPF flesh mortality power. So quantitative to PAM. we'll death as typically or of

able be standard-of-care, on prior by of prior terms to start the In of both we'll who we terms history patients so by standard-of-care, study. analyze in of and stratify standard-of-care ZEPHYRUS-X studies history ZEPHYRUS-X so

distinct patients expect of start will study. We the start of on patients. standard minority later And of those care to the those do be who this many

are aware And work standard-of-care quickly. as you the well doesn't

going intention on anticipating have just clarify we're best rigorous PAM primary endpoint. clinically way to of to actually on And study whether study not the the the that of effect of the study, analyze it on placebo of to by will placebo is is start or not should patients drug very the studies. have efficacy versus pamrevlumab remainder PAM whether end versus placebo. they an or of the So the But assignment the we standard-of-care so much treat this at a evaluation to that's for continue

other Okay. And than the be data prior other standard-of-care PAM with will tolerability? you and releasing any

Right.

data. provide upfront And read to So on substudies run any real out. really, the we're time. going have wasn't you're referring of efficacy how we're this a they really ZEPHYRUS-X. of And or were anything of quite releasing the period there cohorts designed point, to given to Those At not small ZX inadequately planning powered were soon PRAISE. short for

Okay. Great. you. Thank

One moment please standby. Please for our question. next

the next of Our from Cowen. Yaron comes Werber question line of

now line Your is open.

I potentially taking have for couple. you. for question. my Thanks a Mark, Great. also

the a CTGF dose supported PRAISE by And on The you models. first as is and a in radiation data animal unique study prior target. bleomycin-induced noted, one, obviously, positive it's was

if opposed kind Some and of is know share how of any KOLs more sense, of downstream as about don't the the you talk about an central so CTGF to any some intermediaries, upstream upstream? signaling go also of can other I CTGF information

noted Z-X January to be endpoints endpoint initially for for recently were just changed you secondly, is that the of then Z-X primary and keeping you. sort there's And important that is originally outcomes wanted aligned composite was the now to That And was secondary to outcomes. and studies. which in aligned a two just he not why the study. a sense Thank in primarily obviously Z-X as get I

the great questions. Thanks Sure. for

step first fibrosis also it's important IPF. a And lungs in in events CTGF, point is the there thought key transition a pathways which IPF. of mechanistic which in in the to from CTGF is with of are around that number downstream of driver is So where deposition including to mean the cause and the of I an of fibroblast myofibroblast one you're IPF. and of pathophysilogic patients matrix T&L, fibrosis But downstream be cascade the fits the right extracellular

complex a biology. is It

to continuing are We study mechanistic point it about and a it from think of view.

that are question So primary of XX% regions on ZEPHYRUS-X that FVC primary health to We endpoint translational FVC the the world, X, the Phase in and two most and information I about of endpoint that you the death. to correct. global the studies information EMA decline biological your Initially decided think endpoint authorities. for other major primarily change and very, US design progression about this about more has forthcoming standard and regulatory the or in clear the clear there certainly will very or FDA harmonize become CTGF. was it's FVC to more be disease second the approval very point more And that

very thought just that it endpoint. to we be secondary that progression and is clear just the better it will So important FVC make endpoint primary disease an was

Thank like you. turn remarks. for I Enrique to At time, closing would Conterno this it to back

rest your Eleanor, investor much your you call interest appreciate you very Hope enjoy FibroGen. thank very in today's Well, your the participation in much we of and day. and

participation the for your you Thank conference. does today's This conclude in program.

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