- Earnings call transcript Q3 2022

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Operator

Good day, and thank you for standing by. Welcome to FibroGen's Third Quarter 2022 Earnings Call. [Operator Instructions]. I would now like to hand the conference over to today's speaker, Michael Tung, Vice President of Corporate Strategy and Investor Relations. The floor is yours.

Michael Tung

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

Wettig, the will and for Senior includes today's Joining me Officer; President our on prepared and Executive today's Thane design, call be John our Investors open And over call research FibroGen's found Enrique? new are Juan, cause you Enrique clinical limited information, China include to a Scientific call results to in The enrollment, can Chief business business at related of FibroGen and statement results or turn results not remarks subject with any for conduct forward-looking forward-looking certain that XX-Q. risks Mark complete on actual to that our activities, financial Chief would differ Officer; and update of SEC, statements, I Commercial Officer; and regulatory any as risks our section may call events could and Hunter, Q&A. Form www.fibrogen.com. to of like our Conterno, forward-looking and our I press Officer; our other matters. Enrique remarks results Conterno, Eisner, call obligation results, Chung, and including Astellas, Officer; materially CEO. are result these results trials, Chief financial the would is but to, to A Enrique conference Graham, Medical like Juan from after can our call our we recent Financial our not Dr. uncertainties otherwise. statements and and which filings to whether publicly events to Dr. today's projected today's our with Operations. the of Such regulatory XX-K our and Chief from and business of development Each Chris and those Vice The potential format in description and commercial include, FibroGen's a that future the of the remind statement. be our collaborations more webcast that, operations, release other undertake website strategies guidance, of material Chief statements on with initiation, FibroGen. found risks Form most does reporting about made AstraZeneca update

Enrique Conterno

the and third Mike, high-level provide On and call. you, will our open will X. additional with welcome NovaQuest quarter then our afternoon, for I today's our non-dilutive the quarter strengthening Thank good call summary XXXX. which, a and XXXX a Slide Today, Capital $XX will financials. announced with million everyone, your of royalty review monetization Juan we After sheet. the to capital, questions. developments balance call, securing Starting in of transaction important accomplishments Graham, of we Management, third most earnings CFO, the

of XXXX continue pivotal data X We well X roxadustat, early-stage development the our support studies first we Phase and through proceeds late-stage additional pamrevlumab progressing our mid-XXXX, line III beginning priorities, half from advancing strategic anticipate top will use where from our to as programs, pipeline. X in from to as

in press release earlier read transaction our about You published more today. can the

leverage productivity DMD, outside data Number pivotal three, to create to CIA. and as with anemia X opportunities. of areas U.S., our syndromes, significant that the by chronic delivering advanced and patients increasing or pipeline in internal in ensuring access Number data indications commercial Number additional with LAPC. dystrophy X III III or Slide well roxadustat FibroGen Phase external programs cancer medical innovation pancreatic positioned focus. unmet chemotherapy-induced MDS pulmonary idiopathic or need, IPF, is X. to Phase Duchenne expertise for executing shareholders two, our locally unresectable significant the patients Moving delivering success myelodysplastic research on or value disease and muscular pamrevlumab in of and advance fibrosis for as novel kidney one,

on made Phase trials III mid-XXXX. clinical significant of data trials Throughout X. our enrolling to first through very be we the our readouts X in have pivotal Slide progress XXXX, studies. to in exciting move starting Phase XXXX from III Let's anticipating It's half

ZEPHYRUS-X from Data patients expected pamrevlumab of Let's III our with in to from in second of is the expected XXXX. XXXX. of begin trial trial with expected is pamrevlumab Phase pamrevlumab first of trial half IPF is of in LELANTOS-X DMD read non-ambulatory ambulatory in in mid-XXXX. patients patients The pamrevlumab. Data LELANTOS-X, Phase in III half with our out the

expected Phase of pamrevlumab half in LAPIS patients is III advanced pancreatic we III patients XXXX. first are in to out that Phase to announce cancer locally the study today out IPF our Our report trial mid-XXXX. of of pleased expected And read ZEPHYRUS-X to in is finally, pamrevlumab with

these patients from in these on significant disease the with need prevalence approved revenue in patients approved study our diagnosed FibroGen gratitude significant and like pamrevlumab, U.S., see roxadustat anemia in IPF almost myelodysplastic the with will XXXX be X And approximately look III in limitations wholly-owned commitment the our colleagues patients highlighting my potential note, X billion studies. sharing investigators, the potential my China with as of to in medicine a of be pamrevlumab these minutes I'd can therapies program their like represents commercial expected a you number Phase the community as of perspective patients. would to XXXX. year by we With readouts continued net our III well from first characterized in therapies Important anticipate the beginning as of middle the sizable the therapies of IPF a to a in We disease on opportunity for results Phase to relevant with antibody X, a In XXX,XXX for trial and few and IPF program. significant China with opportunity. believe to IPF studies. DMD across FibroGen, monoclonal spend There column, help to current options. roxadustat extend mid-XXXX. therapeutic now additional caregivers desire Japan, progression with and forward patients, we each remains in of to areas I for roxadustat patients opportunity is Slide syndromes and are challenging the very X a IPF. MATTERHORN anemia look to the the with half -- the a and has see sentiment data of of with tolerability. transformational EU, for $X XXXX. Moving of chemotherapy-induced We generating the unmet there a the

that DMD that nature desperately the progression Given LELANTOS of relentless III lead an disease, the program the devastating the community. DMD of approved by and therapy we're to Phase needed is hopeful can

the pancreatic we improve unmet yet that the DMD the approved small Pancreatic advanced be And have While of function in patients that antifibrotic a third need patients. needs progression in and There at of wrap mechanism believe column, with meaningful in up help proportion a solution an can cancer snapshot the disease demonstrate can exon-skipping to ambulation. largest downstream progression. clinical therapies changes represents We increase current automate the by cancer opportunity. locally is the produced finally, a of oncology. and these disease a one therapies pamrevlumab symptoms improvements for the targeted a they're in levels, to clear may muscle pathological prolonged dystrophin or of targeting

benefits the There around patients therapies Given commercial which survival XX%. a survival. prevalence LAPC for low failing demonstrate significant decades, creates a XX,XXX activity improvement a major meaningful limited with standard treatment rate the in in a of disease-free opportunity the pamrevlumab to development X combined diagnosed with over in non-metastatic regions, pancreatic of in also over demonstrate we advances overall the over current immuno-oncology of limited have setting last X-year across the There's survival if care. can with non-metastatic -- cancer, a been late-stage

In the metastatic pamrevlumab adaptive Promise cancer combination Action Precision of Cancer care with in progress. standard addition, patients Pancreatic to for platform, trial continues with pancreatic Network's evaluating

Now let's roxadustat Slide X. on move to

treatment it chronic further treatment believe coming with clinical EU kidney disease in syndromes roxadustat We recently is patients. countries other launched in Japan of of for the roxadustat or as numerous Europe, the continue anemia of treatment in CIA, the the Europe with in and in myelodysplastic was anemia countries in Netherlands We United approved the over anemia The in markets the the MDS Kingdom, China, Roxadustat patients Germany, chemotherapy-induced the anemia accelerating for CKD European the is in commercial for months. Nordic trials and of China. activity the U.S. significant. the launches opportunity and major expected Europe, is and ongoing or with

roxadustat health you from see Slide expected, initial has EVRENZO And than slower continues Our performance positive. EVRENZO the to you feedback moving can providers and quite has its where launched, as X. -- uptake has China, strong early prescribing been on been care

despite We reporting joint quarter of quarter third million This China to and sales entity total roxadustat increase X% to This in the XX%. of reduction the the distribution third net renegotiation FibroGen million $XX $XX.X price XXXX. of by by increase in in are driven growth of over an compared represents dollars volume in the and NRDL impact an U.S. currency. the was of

the in portion third net expect product China full Juan of significant China growth We basis. update. in for continue roxadustat driven by to $XX.X on quarter year net FibroGen's a further million GAAP XXXX finance volume. was the growth revenue in for will the sales in elaborate U.S. roxadustat

anemia market in to ESA be share the for roxadustat. treatment data now by and on CKD continues category, #X which Roxadustat the X. branded measured includes as updated all to value Turning products the external Slide

volume this at as pace. roxadustat grow fast category to leadership expect to continue We a continues

December I in driven slightly is the market up, expansion Slide right. the significant growth where leading NRDL indexed update. roxadustat, has CFO, left, year-over-year CKD Of chart call turn the anemia note, ESA been table as over brand XX of now a to roxadustat unit the reflecting our the growth XXXX as by a this XXXX. listing well the on is as of Juan since Juan? unit roxadustat growth in snapshot its to original financial for the will on on provides Next, Graham, that the

Juan Graham

Thank you, Enrique.

our the our United and States their China jumping financial the on priorities. I colleagues in executing thanking would by to for in focus leadership Before begin into remarks, strategic like

X have in roxadustat and monetization X have our royalty of NovaQuest also communicated, with the in our enrolled supporting strategic As Capital balance XXXX. fully further Today, Phase announced we're to will starting half trials of pamrevlumab III pivotal transaction continue first sheet which with our priorities. readouts a strengthen Management, we we

$XX.X anemia symptomatic co-development with $XXX development. roxadustat patients is substantial represents of payment It associated with change important our XXXX. Breakdown a Now completion for milestone XX% the million to adult the the as compared period results. revenue roxadustat revenue approval in due versus getting is $XXX was revenue to two, Astellas, the the the CKD, net the in XXXX, in million million the period $XX.X sales of of drivers million of for one, partners financial to third of related in which $XX.X for are: from in increase note same our product of million of recorded partner, revenue quarter-over-quarter. European to our Total quarter follows. last sources into a We treatment quarter Commission which and third compared for year quarter main the of a million China to XXXX, from $XX.X decrease EVRENZO

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

results. Given remain expect to revenue range going as we and to in development anticipated forward, communicated, previously the of stage quarter's co-development roxadustat this and

million to as Astellas. shipments change the depreciation a active driven drug for $X.X estimates we per GAAP, reduction versus related sold our dollar. in This product roxadustat reduction due drug ingredients in to primarily Japanese U.S. recorded Finally, to U.S. by bulk the was of currency or revenue pharmaceutical yen the the

was the This quarter of XXXX. quarter shifting focus X% the a of is owned the China. entity compared XX% $XX of and in for an JDE performance million joint XXXX. our represents of million versus the currency FibroGen increase result third This NRDL AstraZeneca $XX.X from price roxadustat jointly Now over our the third into volume reduction Total quarter distribution despite impact net in of this sales increase results by significant the and of roxadustat business operating headwinds. to sales or

our sales. by in previously strong have to growth we our continues line As communicated, experienced with be the expectations year-over-year China of growth operations and in

the million have to was Moving roxadustat to guided. for XX% which the $XX.X consistent the in price from JDE's net China, net continuously JDE third roxadustat quarter, we net sales FibroGen's with transfer from of XX% sales sales the range

estimates $X.X in million estimates. U.S. quarter, amongst our impact we due driven change GAAP, renminbi to by the other per this future primarily currency in revenue unfavorable deferred During as

past, based we China on the balance of revenue. As future management FibroGen fluctuates have communicated in revenue estimates the deferred in

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

research of support $XX.X million was our expense P&L. efforts the development to to with cost and quarter directed million and down XX% supply our and in Diving future pressures. $XXX.X in by activities, pamrevlumab early-stage pamrevlumab trial roxadustat $XXX higher $XX.X CMC dedicated Operating into increase clinical offset our development. to to way is support management costs to operating Of our $XX.X $XX.X our or costs expenses, lower inflationary the expenses R&D million operating the by despite to our were deeper our third compared making programs infrastructure focus remaining dedicated XXXX. towards Now million with overall development. growth funneled drug and capital for This the million million in pipeline driven $X.X costs associated million, in roughly and continues be expenses

equivalents, was cash, During to our $XX.X share net $X.XX and third at accounts today's our further in quarter discipline, million. share strength the investments loss $XXX transaction XX receivable our year. compared -- financial and net million or to we net Capital of royalty cash in along our of third diluted to Slide will as equivalents, royalty monetization cash per quarter enhancing $XXX.X The presentation, the of cash On to our transaction, provide our support income monetization and of to we the accounts Considering and XXXX diluted XX, loss receivable. basic for $X.XX XXXX, last our million million additional make Management, the focused million investments sheet, on to per reference cash, $XXX reported announcement $XX.X we with position or range that NovaQuest cash with basic be estimate ending balance balance September of organization.

we have variety like we're able sheet. to over strengthen call to to balance Enrique. of be a to consider options back And stated, I Finally, to would our previously Thank privileged as the now continue you. to turn

Enrique Conterno

quarter Juan. third to you, And I Very closing, would good. Thank like our in reiterate developments.

transaction, which us strengthening Our financing our of capital, transaction, further $XX our balance million royalty monetization gives sheet. non-dilutive

indications Our advancing a commitment pamrevlumab significant medicine Phase unmet to as potential needs. first-in-class in III developing with in medical X

data III in DMD. We from in well X LELANTOS-X very line to perform with pivotal Roxadustat in continues expect in pamrevlumab DMD, ZEPHYRUS-X and in IPF top LELANTOS-X XXXX studies, Phase patients ambulatory China. non-ambulatory

top in in over and of to with CIA, read respectively. out Our mid-XXXX, the with data China market forward of trial expected the anticipate trial in pivotal commercialization half MDS X partner, in Astellas, launches EU roxadustat XXXX further moving are studies, XXXX Europe which and We EU first reversal decisions markets global from coming in X months. -- the X Phase line is roxadustat major and III expected the

million We XXXX, with cash. end $XXX financial continue to year with strong of position the December in cash and expect XX, have in a to $XXX as million million to $XXX.X

operator would I We call And our consider questions. our continue ensure for to strengthen to to options back further like balance now to sheet long-term the turn to success. have multiple to the

Operator

[Operator Instructions].

from Bank Our first America. Jason question of comes of Gerberry

Jason Gerberry

or sorry, enroll rollout PRAISE severity of on kind PRAISE you I'm medicines. new IIb I were was A you patients subjects confidence which trial? the for conducted, to of Just of to specifically underpins speak couple of that IPF is the opportunity. think -- seeing when just market care me the the standard similar what your Can can Phase IPF

and if just an is market on wanted successful running trial. thoughts they leader an ZEPHYRUS your that? the get to that get programs, the your trial, on secondarily, thoughts BI are wanted So then to in adjunct running And adjunctive given

you you're you that think program or pamrev important competitive is can that so highly as the running? do be to how do a think do with And monotherapy the

Enrique Conterno

your Dr. going you, Thank for here your Jason, to questions to Eisner. pass question. I'm

Mark Eisner

Yes. Thanks.

perspective question about the we question generalizable of have. in severity I'll enroll similar And your my IPF of range mean, colleague, a our start, your and the population confidence might program. of patients second adjunct combination and ZEPHYRUS yes, cycle ZEPHYRUS range very at PRAISE, patients, confident. severe, commercial any Wettig assuming more or So positive. of that are then patients are I certainly looking ZEPHYRUS can expect including sort program have of then we we to of options, first the population we're a a patient to enrolling broad kind trial, a in going highly for are that of turn Thane I'm to our trials life around But to he we

could We options will several of one be them. looking at be that

I we the data the placebo us signal design very will of to really safety will ZEPHYRUS the very be informative -- and monotherapy a believe to very think program clinicians. efficacy that because actually be informative will our compared give highly clean

So your about what more thinks of market-facing Thane potential some of me let question. the see

Thane Wettig

Mark. Hi, Thanks, Jason.

a additional scenarios, standard pulmonologists have on of needs Ofev combination, with back consistently consider that and that share the if back if they that perspective, somebody terms now reaction speak care. our with of further have say, replay when Phase data pamrevlumab long they don't we data, then And to in to then Esbriet, we efficacy us to just and further get then a top care. speak is key see of to along have I natural of on tolerability monotherapy play they is about a for inclination options believe use even with without they They have just profile questions continue the of about when how I'm product the as data Esbriet, know we want together. they combination hey, or understand PRAISE I Ofev to strong -- confident them. pamrevlumab they them the have or then either we can them about to highlight us efficacy who one add an they you understand and able be go trade-off program III inclination the standard the as they a as pamrevlumab is as they back to they ask current of anti-CTGF, press and of profile, mechanism the either have potential of product, to pamrevlumab issues how your label perceive that and that the we well tolerability we we As what from is in And any hear them what right natural don't with then or to

thing again or many for other a disease step same areas, for natural with so not physicians we've or very this do. Type we just Esbriet, say many or payer thing you physicians areas you And or -- heard X these other research unlike pretty that it's we Ofev confident about add-on it's have then unless that disease U.S. will with them. over pamrevlumab there. cannot pulmonologists therapies, diabetes and go think it's where And we're hypertension And the in over restrictions use It's as common a if to that next

Enrique Conterno

ZEPHYRUS-X I let will a will there data, just in number add Jason, opportunities with front Clearly, think that us. one more be of point. Yes. positive be me of key

them, would to I is internally. the those you have be consider the some course, have frankly, but to of at for opportunities that of not top we us. opportunity outlined described here look quite We one of What data,

including additional what of where So would to believe adjacent indications number IPF, we to call going opportunities, I'm the work. product a some

data. So the now have to we just wait for

XXXX. our We having look are, and press given on we enthusiastic of highly the that conviction course, forward an have we based to incredible results,

Operator

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

Jack Padovano

calling Jack for is This in Annabel.

tolerated that understanding now, is So patients who enrolling trial think current treatments. not been PAM and about my haven't have IPF, eligible who right the or is

current percentage of you're the successful the also paradigm expect and versus there offer after? in shift? who ineligible? treatment or designed do or first-line how Esbriet indication a fibrosis IPF potentially Ofev before reduction, is do therapies sense to If enrolled position you Is of the you are of have the And study naive population to some a to

Enrique Conterno

again Very going once Jack. to Mark your respond have Eisner good. I'm to question, Dr.

Mark Eisner

thanks for question. no, your Yes,

who So both just ZEPHYRUS standard standard to have clarify patients trial. naive have into the discontinued and to of program, we on been prior the are care in entry care of enrolling patients previously and

is for patient expect broad we patients. And about we're going naive reflecting broad So that have experienced that the thing patient population a treatment population enrolled. would to very of label we good includes that a both very and IPF the the

their So clinician to they we on the they that have expect good of of a IPF. point the based profile all view make also information need patients for for will risk from pamrevlumab decisions benefit

Enrique Conterno

he I the about percentage. also asked think

Mark Eisner

Yes.

reported We ongoing mean, those publicly. haven't trials. really percentages I they're

the we moment. you right at data don't for So that have

Operator

Our Yee next from of question comes Jefferies. Michael

Michael Yee

in Phase seen have we're on previously II? had have up you lot IPF questions. to is on or or whereas that I either because to what versus to the in wanted the for reason ask that following the questions, intolerable assumptions in II, And it seeing the understand Phase that and part One, failed at of in patients powering the the all. what how designed had orals, idea that us drug terms never remind III related of Phase We they of two placebo you we a

idea And referred as there is patients are you so to. the here sicker that

II? triangulate So the population it wanted to powered based sort you what on different for seen here of just Phase and

Mark Eisner

question. Great Yes.

I studies robustly have to of effect a detect to powered mean, be versus placebo. terms treatment in very the pamrevlumab able power, So we of

too we're for more learning is it's group, progress what versus perform next or to patient is to be studies think part from who power statistical expect clinical to much labels than I how patients particular, then other on individually, And the based for you So pretty into we other interesting ZEPHYRUS-X. trial ZEPHYRUS-X, And would continue more in in Esbriet pretty would placebo year, the should go the an Ofev. that around you each in are treatment because naive trial. experienced trials interesting adequate anticipate than the a over of your experienced think that's question

well, actually do Esbriet best and progress, trial and even if you're you they are really they in discontinue from And disease. that it are Patients are be -- doing patients discontinue is the or enroll patient you're if are the why typically patients trial. just enroll good well, in therapy enroll patients you're So that to to on Ofev progress trials the continuing and who naive theory not in about symptomatic you're the the a are. would as who going to doing

actually on despite care the standard of they've in So trial they perform past. been they the -- progress actually fact on

providing So opportunity naive us I group, the on show or the thereby whether trial to benefit. that pamrevlumab expect a the they're think experienced, in with those to we placebo treatment progress patients

Michael Yee

be Yes, second could population in that. combination. it both But the good just or be thing to relate other the difficult interpreted to more for a follow-up a in you general. Thank also question, has which could a placebo, faster

was about that do made particularly fairly if some course, of which recall attractive, good combination think, And there previously, therapy, works. you combination study, I sized. comments So is nice I a it

you that? Can I from us what study learned positive, and from combination was any was your safety never just the of never you remind but sort think the there takeaways presented. was information

Mark Eisner

draw it think patients of more acceptable. Esbriet combining safety or of was very, tolerability very you summarized actually but the efficacy number there's to pamrevlumab quite I I Yes, was it well. any able mean really the and not with than certainly Ofev small a conclusions,

Operator

Danielle comes Our James. from Brill from Raymond next question

Alexander Nackenoff

This is Alex on for Danielle.

another the considering on same. IPF Just one

baseline to vital of is capacity of lowering enrollment as down of Just needed that trial? curious Phase capacity you Just kind to to curious at if efficacy these include screening the not changing vital the makes III XX%. to going your still the expand? I'm cuts of data forced you forced criteria seeing capacity? that of any curious II Phase to evident, kind failures was kind post-hoc Were vital working a it on confident just there thoughts hear low pamrevlumab function the in that was harm the forced and

Mark Eisner

Yes. Good question.

No, looked first. interestingly, analysis at wasn't tell there a been both Esbriet predictor question efficacy trials. post-hoc less in question Ofev of Ofev second has and the as greater is in or trials or So severity, not And really higher can I thoroughly at that looking predict those pivotal FVC, Esbriet there you efficacy PRAISE. lower pivotal does agents. no -- FVC a was of or in What

expect So trial. ZEPHYRUS in FVC we would and of reducing couple trial. in failures reasons. did important XX% XX% enrolling PRAISE key lower the the a to you We for similar program. from in really our Yes, correct. you're One to That's screen the one mentioned, it's

on point my virtually and adverse including have If end the effect Phase don't III spectrum. some slightly the anything, we in that comments, harmonizes it IPF with on conducted on been being expect any other in programs that patients based all the that to the severe we advantages of And are conducted think more now. past there's the really is that, Second pivotal have trial. the

Operator

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

Andy Hsieh

Congratulations on done. getting that deal

the question quick So just . on its regarding deal, a

Astellas question also that, do will from we a Also IPF. are on of So know royalty quarter? you future related estimate much getting also wise this framework roughly how to count per first have the within deal? milestones we is, And

one you mitigate kind about of if China that XX-Q, have a is in is quick between you in the context IP timing the earlier a just further shrinking I'm the guys I just time? little of timing in kind market mentioned the trials the difference on noticed strategies about to that terms is are apart readout possible, but difference there dialogue Difficulty] X of obviously, company, of So of Phase in roxadustat. bit engaging of the whether exclusivity? crystalline in the of in the comment Third maybe about either kind this one. probably can curious [Technical a year not you

Enrique Conterno

Sure. the IP actions. and and on could and particular, I'm deal, position to and do then our comment Chris the to questions your in And Chris, to have that on to discuss forms. question the and we the between or crystalline it strategies IPF to Mark, respond going trials exclusivity on timing Juan I'm going give the

Juan Graham

think basically Juan. context you to it Andy, think in to I this the your generally with been With XX% have as entitled would regards launch in we're of royalty. Europe. we to Clearly, a that mode way we're think to question, the are the more royalty, be I under following, probably is the deal, about Astellas regards

it's to enable, time. numbers talk and Europe this in So of few months point key the there, our months territories royalty. the in clearly, about But in growth therefore, reimbursed to we fully or in next expect next obviously, will the revenue difficult which in couple be growth at in

So that's entitled around piece. way royalty to know think I XX% And to but that we're mentioned, that transaction. think I about think from the don't I I if

in be think And sales-based of terms milestones, that would yes, there this I be future. portion in there here milestones as are out attributable well just future transaction. would In the a

are So the I X think those components.

Mark Eisner

Yes.

readouts IPF the of between ZEPHYRUS-X, about question the and your So yes. and ZEPHYRUS-X difference

-- potential filing So the the data FDA ZEPHYRUS-X to them in with the strong the communicated continue that we ZEPHYRUS-X are we discuss compelling That that filing trial, trial. we've and the and and for case would is one we'll both positive assert for to if with previously pivotal U.S. said, go and ZEPHYRUS-X need base

there's a think that like severe disease precedence for I IPF. rare in

to one case, X but discuss possible base could trial for trials, approval. whether do pivotal FDA suffice we So everything with

Christine Chung

to exclusivity, have respect a have market including crystalline patents of avenues we of China, method our multiple robust and other yes, to exclusivity. patents patents. protect are, course, where to matter form one composition we exclusivity, In portfolio, with and And

So this form exclusivity. is just one of

form round, We crystal [Technical innovative round the first We invalidated, and invalidation during a exclusivity the yes, by administrative crystalline regulatory China, to patents with is respect rate X were With information the as is Class the virtue publicly about hearings. first being patents, drug. XX%. question also the is had specific invalidation of of have X context which in this available expectations the Difficulty] domestic that consistent

on So courts. appeals through X to of There are we now rounds go appeal. the

that years get take years to to to expect X X resolved. We

still we're early process. in very on So that

Enrique Conterno

you, Thank Andy.

Andy Hsieh

just follow-up. a Chris,

in the enforceable are all the just of patents process the like still U.S.? During appeal,

Christine Chung

included. They remain they effect the process appeal are. are in is They until --

Andy Hsieh

Got it. Got it. Great.

Operator

One moment question. for our next

comes next question Our from Choi from Sachs. Paul Goldman

Paul Choi

that and limb moment have just what on prospects the you feedback ambulatory for been I assessment, on endpoints? And the DMD. here non-ambulatory the on the on population understood that that endpoint? a switch can I case to somewhat in I for regulatory little maybe for other the you've to us with trial. it's want the maybe historically to been cautious regard approvability it upper hits But know particular well drugs relative to has of remind instance less a the think filed gears

Enrique Conterno

Go ahead, Mark.

Mark Eisner

And could a therapies a this believe support need. Paul, are either medical it's the endpoints. available that regulatory The for a unmet really dystrophin based biomarker. currently approved therapies are very or is clinical ambulatory approved We filing. population non-ambulatory with positive Mark. clinical data question, on There Good no high LELANTOS-X, disease population the on LELANTOS-X,

believe support filing So by itself. we that trial either could

we be to of would based that, the but would have course, assessment. discussion on that's FDA have data, a the our current So with

Paul Choi

Okay.

Enrique Conterno

regulatory on the think to endpoints? the also interactions related he I asking Any about questions -- was

Mark Eisner

Yes.

right. -- So

draft for actually on a the other guidance And used and that guidance have or that has are trials. the where supported in have -- supported upper the in FDA but of that probably both endpoints So been for nonspecific, aware are population. guidance pretty population limb ambulatory they're you're these DMD non-ambulatory both the the North endpoints, there's the performance Star

confident endpoints. about the very we're So

Paul Choi

some to thinking And burn also of year, question did think what's paring end for rolling have OpEx several have or as I you'll the come trials Juan off. you Appreciate cash here. maybe burn I just for of financial about a year. remainder of guidance But trials ask to rate next to as maybe late-stage the you look the stage initial Okay. the these completion? wanted just the down on obviously how or

Juan Graham

Thanks, Paul.

But to a we XXXX, I back and come we're through, we're financial our think and called on, planning as you looking little of clearly, call all would as But the up happening in ramping rolling clearly, visibility. readouts. of activity on you as bit there's earnings well, at more will for processes, out with so provide off. subsequent pointed potentially we depending clinical potentially a lot in trials XXXX our as out going start probably launch

components like. over what and we're will we perspective think XXXX those I the looks further months to all coming currently of discussing, what provide So is

Enrique Conterno

Yes. you assuming to those expenses we -- are some Paul, some those trials bringing additional It's trial, conclude. those in market. as related expect, dynamics lower of expenses correctly one you here. side, have state, will But have also will we to can products as there On important -- positive trial

about that an many to guidance prepare of exciting we next XXXX. But need exciting some think type time so those coming be to -- have year, how exciting of of readouts time for cash to we to to in pivotal given for for an how data it's time, about as provide need it's dynamics. an we're we thinking So patients going FibroGen,

Operator

next moment our for One question.

Our from Werber next Cowen. comes from Yaron question

Yaron Werber

First, these is what launch just of or actual next is that study say reflection quickly processes slower the of And see little launch reimbursement also expected, can more there might opportunity European of WHITNEY some mostly contributing Phase And saw something when country to that the roxadustat. in dynamics? some bit of remind just it's II kind just if us of the that's a clinical really CIA? a with Europe about you or been study you negotiations on China individual we you year? commercial in than then efficacy report kind When data the in you of

Enrique Conterno

I'll performance answer Thank questions questions. have Yes. Thane the for and chemotherapy-induced answer you European question. the the anemia Mark

Mark Eisner

Sure.

So the dose kg hemoglobin there which head-to-head take population fact, X.X and that versus we And a the to and per selected study Phase we of X mg -- II increase what and a China is next at Phase forward China aimed WHITNEY in exclusively is will improve that design we study roxadustat. And III that the ESA, the excuse looked at is ESA, year. out study anemia, China open-label China exclusive was a is the can, the showed it's and that study and doses into versus market. read mid me, study, China non-inferiority the

Thane Wettig

-- EU Astellas date, and his And other remarks, Juan Germany France, reimbursement then expect in guided, end the and previous Italy the performance in said game, awaiting decision U.K. and than March. then year, it stated to in to Hospitals their of because related have to primarily the U.K., guidance. fiscal still the terms expected, in be as between would NICE end the as by reimbursement NICE markets through they then regarding and granted The which of being slower that has decisions July. those we is Germany as the still now NICE X it's early in performance in and Spain, XX reimbursement early in of adopt that's in have days the approval in was

of bit anticipated and been care been years, it's is replayed physicians ESAs just as reality that favorable. so a fact used Enrique still said experience difficult their using of for back I in in in the at care breaking XX that U.K. think into -- when than more standard so That are standard that very looking the a the Astellas, to we're have in habit. his been to early remarks, using And experiencing it's really roxadustat, that's we're what place of and physicians it's And what

has And drug China, clinical there's benefits about an so phenomenally relevance and the just ESA. well, the relative where no seen of to in doubt as the roxadustat performed we've

into perhaps anticipated. take longer to think I of a just little that standard care to habit bit it's penetrate going than we

Enrique Conterno

number in intent be research the a huge looking add, is reimbursement Clearly, countries tends we catalyst, high. European recently -- but to Yes, really, maybe at prescribe. of really just of we to prescribers conducted some intent to a market

And So to look Europe, very -- opportunity we reimbursement, to get catalyst. a significant. as need we think excited we the in about the for we that's critical is very remain continue roxadustat remain at overall the future, -- but we

Operator

to Thank Chief Conterno, you. like I Enrique turn now it Officer. would Executive back to

Enrique Conterno

to FibroGen. Well, thank interest you. and much. your day. thank I participation for enjoy much of hope your in want call you rest your Thank you And I in very very investor today's everyone the

Operator

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

may disconnect. You now

FibroGen (FGEN) 8 Nov 222022 Q3 Earnings call transcript