FGEN - Earnings call transcript Q3 2021

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Operator

Hello. Thank you for standing by. Welcome to the FibroGen Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speakers presentation, there will be a question-and-answer session. advised conference be recorded. is Please Instructions] that call today's being [Operator Instructions] to today, your like would Dr. the [Operator now to hand I conference over speaker Michael Tung. Please go ahead.

Michael Tung

third and Josh. President Vice Strategy at to afternoon, you, Relations Corporate call. everyone, Investor Thank FibroGen's Michael Good of XXXX FibroGen. quarter and Tung, conference I'm welcome

Officer; statements not regulatory commercialization strategies design, cause statements. of business; regulatory in include of plans, results our our conduct, trials; results strategy anticipated related may enrollment, risks, of could statements Mark AstraZeneca Chief on that China which anticipated opportunity, remarks FDA Medical matters. we clinical results; financial for made Scientific may Officer; regarding, market and Chief initiation, today's call remarks like Conterno, operations; and our to Wettig, Financial Such Joining for our our Astellas; Dr. statements limited Thane are call and those collaborations me research after Hunter, our from and up to Chief open includes Commercial and would differ development Chris Graham; the call on on the but from our and such Chief expectations. results today's Eisner, Operations. prepared The forward-looking activities; Enrique and certain forward-looking FibroGen's are actual our call interactions; and Executive to, Officer; format John Vice current will Officer; subject that Q&A. include Juan, Officer; potential Dr. our risks uncertainties with statements Chung, our Juan you President Chief and Enrique based guidance; materially remind and I Such today's business other to significant to Senior

today's business XX-K that, All could and X-K future affect Xth, For a obligation FibroGen not the results Forms as information, quarter in we FibroGen's and and to any of be financial call update recent www.fibrogen.com. fiscal release quarter Commission. publicly that disclosure does and file results at as other except most on events, undertake business, reports please as a With to business like a Enrique? to the XXXX information Enrique any on based turn fiscal call statements and statements, the XXXX, Today's update, reporting required discussion website webcast that available risks of conference to financial November our currently today's may I can section refer law. or release made Investors of whether by found XXXX our XX-Q, our third press our Exchange and reporting us, with forward-looking otherwise, are financial and and future these new and and on Form would our factors of update Securities result material our press to the CEO. results of Conterno, today, third over

Enrique Conterno

developments in the and financials. to welcome Today, and will I Thank good. also newly quarter provide summary you, recent everyone afternoon call. appointed third good introduce months. like XXXX who earnings a Mike Graham, of important like high-level to to and our I CFO, welcome Very our Juan review would and accomplishments would

to in XX to ensure through continued call strong include stage a private and who serve thank We years. transition. to roxadustat and an September XXXX at also update Executive in transitioned will down a as will your Today's our from status to smooth the will China. a public of of I the March from who Pat company. company for performance FibroGen development commercial-stage regulatory open Adviser and for leadership, then Under questions. stepped CFO his call want Cotroneo, as worked Pat FibroGen

the started EVRENZO European with we symptomatic So, started? for treatment don't anemia associated In the get disease. chronic August, Let's Commission with on approved kidney three. why get roxadustat of slide

Kingdom, launched and HIF has healthcare FDA EVRENZO providers important feedback the first-mover advantage has and PHIs. to roxadustat of an FDA Austria, is response from significant, in positive. relative in early United Netherlands, CKD The and received Germany, other completed is for letter opportunity the recent Europe Astellas for potential we we chronic The the of anemia CKD, roxadustat AstraZeneca, reported treatment of forward performance. China, have another additional major setback. a path strong disease, scheduled. of an of on discussions our anemia however, and we with and anemia are kidney partner, meeting represents We in in quarter the In a

XX Week AstraZeneca XXXX roxadustat related and the we Conference. Virtual CKD presented week, our Astellas last to at partners, on presentations Finally, poster Kidney and ASN

slide Moving and the now reorganization. to four recent

U.S., regarding beginning our strategic Given priorities in the are us that pipeline. which of advancing uncertainty includes developed cost enable the we reduction on a to roxadustat path development comprehensive effort and and forward a have pamrevlumab, focus would roxadustat, our plan, of implementation the of

for projected year of reduce the three by $XXX approximately to each million is plan Our expenses years. per next

approximately eliminating of in are to XXX existing employees contributions and FibroGen. all We were are open thank which their are We whose XX% meaningful the positions. the positions positions XX% US, positions eliminated for

idiopathic our areas roxadustat slide muscular three, in and to dystrophy. to the in path ensuring U.S. additional accelerating kidney the the accessing indications. pamrevlumab fibrosis, advanced to pipeline of of opportunities. for in with focus. exploring significant be expertise positioned value leverage continues with chronic innovation programs cancer, five, unresectable indications to significant needs, research for advance while with patients that internal of shareholders medical locally and by FibroGen and a on disease pulmonary our a patients external productivity into development U.S. additional pancreatic outside and Number unmet for Number two, potential expansion executing Moving create three novel the three Number success increasing commercial one, therapeutic Duchenne

and the million we're As in you total report $XXX.X quarter see distributors for million of pleased sales third XXXX. slide roxadustat on $XX.X can to to net six, year-to-date China for

China roxadustat the for product revenue million of increased third reported see net XXXX roxadustat to quarter year-to-date. $XX.X continue million We adoption. and in $XX.X FibroGen

of As on the on roxadustat slide market NRDL. see growth the can since has the inclusion you ESA seven, accelerated

over In growth meaningful in the same last the fact, revenue months prior has period eight shown over year. the ESA

Moving to driven is same Roxadustat the an of the share category ended XX% the expansion of eight market. August in anemia has and captured category Roxadustat XXXX. for expanded slide capturing months XXXX of CKD over the eight, period in the growth

ensure is roxadustat, products the the CKD currently months, number PHI includes that value within as slide recent China share most of branded shown treatment the anemia market. of eight on HIF segment for roxadustat achieving Finally, month on the in the only in for past the XX% nine, one and all ESA care a end, year the for growth and keeping China, goal which the of roxadustat finalize will expect we By our to patients. revised look lower, prepared price to of be are making forward to China roxadustat you We anemia year-on-year. as CKD standard in continued long-term updated we reimbursement treated in advance

CFO, now turn exclusive on programs for assets other we time options we Graham, to our to quarter. will agreement. the Moving XX. reiterating now under the development the program the lines financial evaluate opportunities Therapeutic progress license And and last Juan? our slide clinical Juan our available of continue reported are on over update. make HiFiBiO to Today, call I the to

Juan Graham

I the Thank join team. you, Enrique words and welcoming as appreciate the

Cotroneo I supporting FibroGen. looking by jumping start let developing his significant extend two areas want for stating also am to unmet decades. for my excited thanks of to forward in, of to delivering to leadership vision our value and Pat in innovative to contributions organization to organization be joining last to I'm and need addition the shareholders. medicines I how Before the and the commercializing in me our

into the for results Now, getting our quarter.

XXXX third compared the for to was same $XX million $XXX in we of As total as today, quarter announced period revenue XXXX. million the for

and into diving reminder, a of our sources revenue. Before four revenue performance we record as

license from First, being probable license revenue, or period. in earned deemed milestones earned of which payments and is the allocated

Second, development from other revenue activities. revenue, revenue which and other development and expense, from development reimbursement, is

revenue product includes approval Commission European sales with and recorded And quarter, recognize we In revenue, CKD. million $XX.X JDE $X to drug from to million revenue to Astellas between the for joint total price. payments for and a upfront the adult other $XXX out-license respectively. quarter, in payment from to which of is Eluminex patients allocated drug roxadustat direct from revenue. our million to revenue, China or or in from million we In and to revenue, which sales fourth, as collaboration distributors and related of development treatment transfer revenue, our transfer API the license license in distribution anemia shipments symptomatic partners recorded net third product of a $XX.X is at third entity payments development them. addition $XXX.X for related price as EVRENZO, This which includes made transaction million associated with amount milestone commercial-grade our revenue in the bulk Third, product

During quarter sales direct as the distributors. to million and net distribution recorded includes or for Enrique, sales China. stated earlier FibroGen made JDE, and we roxadustat $XX.X our in sales by revenue million million $X.X $XX.X joint product from the This to entity, of

share. for XXXX, by items. As China was entity paying AstraZeneca's we these jointly for distributors selling roxadustat in profit AstraZeneca first starting quarter of have distribution AstraZeneca's the JDE, and portion FibroGen, the to owned commercialization began the disclosed, FibroGen responsible efforts and previously and or of Previously,

its the direct to for which accounted business to for volume, growth of XXXX. through our XXX% To operating For roxadustat FibroGen's the over sales roxadustat quarter the sales was XXXX, sales third represents roxadustat distributors. of XXXX, the results to JDE our distributors, distributors third context net to for JDE the direct China's XX% million $XX.X including X% million with quarter the China total $XX.X remaining and the for sales, occurring the compared through FibroGen China, in third of of quarter in total provide sales

which roxadustat to $XX.X guided. FibroGen's revenue growth defer FibroGen growth net recognition encouraged performance this we we million the have revenue and are -- portion market U.S. with sales GAAP. After roxadustat net we deferral, expect in the our for net sales this quarter XX% to was continued for We JDE recorded previously of certain in China to million net quarter, purposes from the consistent the the transfer by future. strong for price continued third the range $XX.X sales the operations, the price, from a From to the transfer XX% JDE. of JDE's under

any related to for product not third quarter, the did Finally, revenue revenue. we record drug

down P&L. moving Now, to

FibroGen costs to this QX a quarter XXXX China this to by of the by increase context, third around between amendment is operating comparator expense the for versus and reduce put roughly This amount During co-promotion China the the unpaid quarter net $XXX and during AstraZeneca, was hence the of XXXX. XX% expense the amended adjusted XXXX million, totaled third of operating quarter, offset China. a one-time the by To compared of adjustment million million the expenses. driven In year expenses quarter China to of the or QX agreement, under $XX.X portion ago. the in historical third were related $XX.X owed charges variance $XX.X million driving FibroGen SG&A XXXX,

costs primarily by year, prior addition, Phase quarter, In R&D trial to clinical or the $XX.X increased programs. our in million costs pamrevlumab including associated X driven drug third with supply by expenses, XX% compared

third diluted for third the compared At shares, equivalents, million and shares per or million diluted $XXX or net last was accounted $X.XX cash we cash, the basic investments, $X.XX EPS $XX.X trade basic quarter, per $XX income in XXth, net to per and September for of and receivables. both year, During respectively. and million as respectively, quarter $X.XX income

million to savings that, realized back certain to the payments the primarily well like guidance to forecast, ending investments, in The our on this and of our XXXX receivables in With based would range estimate Enrique. call XXXX range as timing is latest to to I to as we $XXX expected million equivalents, cost balance of forward, ending cash the net attributable our $XXX of of $XXX over from turn previous million. Looking $XXX be cash cash, in trade to the increase now our be year. million one-time of remainder

Enrique Conterno

Roxadustat Phase our we needs, portfolio to Pamrevlumab reduce and and fibrosis, a medicine and expenses, on look very advanced development closing, pipeline. priorities China, continues cancer, In focus first-in-class X advancing of potential continue medical locally has unresectable maximize the and dystrophy. which is of perform unmet Duchenne significant to three well will with and in indications in idiopathic muscular pancreatic pamrevlumab, value commenced commercialization our enable our pulmonary development to strategic in us now in Europe. to roxadustat,

have to with cash the continue $XXX slide year to $XXX strong $XXX XX, on expect to cash. million shown As in approximately a million financial we million in position end with and

delivering areas to of goal We unmet innovation of our meet needs. are well-capitalized clinical to

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

Operator

Thank Annabel you. [Operator Stifel. Instructions] Samimy Our first question comes with from

You may proceed question. your with

Annabel Samimy

my that wondering and the have in I that, nonstarter competitors Hi, a picking for noticed as complicated since if the I roxa space the the are clinical U.S. of you. investing CRL, could on have was you? that namely landscape, are work that had willing that be they guess, the has questions. and any the you've well? you is would of enrollment that okay thanks the discussions guess, Thank therapies what drive the continue And AstraZeneca you studies, is And taking having and and then as for additional agreement in study I new catch-up the change altering both given far U.S.? just for any competitive as in with MATTERHORN to in down whether of up on slowed secondly, what

Enrique Conterno

Very Thank your much you good. very question. for

AstraZeneca forward do with we ensure I we Mark the ask to Eisner basically path forward, to to to -- path of have plan it's the with I'm only would say, think discussed is whatever and and is, course, me have and what we an going not aligned need potential that FDA. I complement aligned AstraZeneca but on

But ask trial color can I'll have the question can there that And on continue questions Mark going agreement. your do the in in provide more be really, the in at to then comment complete a for So, manner. CKD. I'm a that question we meets able access that And is and to to time, ensure response we the commercial is able to that we conduct of anemia U.S. collaboration same us the bit an letter the to no -- to how in believe be answer expeditious product.

Mark Eisner

Enrique. Thanks

we said, AstraZeneca closely forward. with the So, determine as path best Enrique to are collaborating very

We the And near very doing to are in on FDA we're planning AZ the with to with meet jointly this discuss highly aligned that. future.

in question has affected studies. a about it and CRL the or MATTERHORN other asked study the You enrollment

slowdown the noticed after We any haven't CRL.

seem think to and interested the investigators I clinicians and very be studies in still those enrolling the studies. those

you, So, Enrique. back to

Enrique Conterno

when with And we here in AstraZeneca, Yes. is about it And our to clearly, how be relationship path do the discussion this comes will with the as potential FDA key far forward healthy. think relationship U.S. as the the

have Of are very U.S., teams course, in we suffered path an a the significant setback closely. here aligned and the I think, but we're collaborating, trying to forward

Annabel Samimy

Thank you.

Operator

Thank you.

Edwin next comes Wainwright. Our question from Zhang H.C. with

You with question. may your proceed

Edwin Zhang

taking last We Hi. agreement Thanks with operations. your you roxa questions. question A my China. China know amended on on year, for in AstraZeneca

there? sales bit expect profitable the of China. roxa for growth and this profitability the do be purpose current you in China, talk achieve you Can One major was of go FibroGen in about amendment a business to to Given sooner when the further?

Enrique Conterno

Clearly, comes profitability in our our it to are profitability good. very Very -- China. overall and progress performance we when Yes. about excited

to significant the -- I demonstrated increased we say had success. that gotten from I think adoptions. reimbursement fair Since this is think quarter see this NRDL, has we've the product the And continued again. it's

As in the we used a hospital mentioned be past, driver. major to listings

with really And largely opportunity We agreement within listed fair things now the well. say China. I did now is listed The adoption of the the those question of anemia CKD are universe are or it's in in AstraZeneca. going for XX% We to amend the about very hospitals. increasing think

FibroGen this, out, profitable more for business. meant you well a point I as and think predictable

progress. of product we've the that very in I maybe a think difference end and the a At comments. the going made important Juan performance the of additional -- makes regard. now few think overall ask day, So to I'm huge I make to

Juan Graham

Sure, Enrique.

product. growth has just in of as component the I we think, the around are the around China Edwin, apart good is from Enrique I what earlier, that other mentioned a mentioned, trajectory,

are, our have XXXX, which we at that profitability. well being start our for in in time as addition to that China, point We -- cash P&L in well way I of tied well think, to some profitability is repatriating in able to this on as

and on continue think, within to business. continue to to overall, on able we are the fund Chinese being So, I well path operations well track as that

Edwin Zhang

treatment mentioned is roxa as patients first-line it I clinical the think, some CKD for Is Also, care becoming of in over Good. roxa in in standard ESA Enrique, Can anemic that is included you officially or Thank patients? you provide on China this? for guidance the the recommended you. China. color

Enrique Conterno

China. other a together you roxa in becomes an in critical. included and I Yes, product, included is new Indeed, been the this But know, is question. with guidelines It of this excellent as for number think clinical has treatments. inclusion ESAs

has roxa basically having. we becoming described, how market. aspiration I since we the we've the care think standard months, The by launched is mention at we when and increasing. roxadustat look just seen few continually basically, just share largest but with we we're market is that share -- higher. still at When Clearly, share, I are now is brand in that that. is we're think made an a at was very XX% related of pleased It to the that performance value capturing reimbursed, the about it's I roxadustat -- and is value not And last what's to expansion by look important, our of relates looking think, the I China. XX%,

are at expansion even an rates. are faster fact, ESAs In growing -- of

need, a the of seen in is China. So, and the reflected that unmet marketplace we have increased CKD. there's Clearly, lot basically anemia there in promotion of and roxadustat

progress we where are on in of pleased very are withstanding terms the the we China. So, today in --

Edwin Zhang

you. Very helpful. Thank

Operator

you. Thank

with question next Jefferies. Yee Our from comes Michael

with question. proceed may your You

Michael Yee

afternoon. I had guys. Hi two Good questions.

you with some partnership? update on scenarios include you. when So, with out happens? maybe lay with AstraZeneca, the the in the and is another base to scenario the generally would is you FDA, on that of reasonable stream. study what and position, you can to when just the and on not see? And of goal so run and Presumably, doing think this be you tree the to FDA a make timing case that maybe you whole that the alternatives update that the rejiggering Thank the up Following us comments speaking, various could would the some is

Enrique Conterno

the you. FDA meeting Yes. Yes, is That with Thank the shortly. of course, critical. meeting, coming the up scheduled is with --

our think complete response and the we've the the that will to conduct path to is FDA. of with -- given trial be I the able discussion we in CKD. basis, the letter is basically for with forward to Once an aligned -- that bring we the in given need to market U.S. FDA roxadustat have a anemia

to at to the point that think think want in an the provide different think, I Right I in case. we on not position, time, of scenarios types of don't that's to sure market. that I better how that's I now, make the if update think be in here to we'll a I to -- want speculate the terms meeting. have

have, go there. think, discuss make the with a where proposal from we good We see and we'd to like to I FDA

Michael Yee

Okay. you. Thank

Operator

Thank you.

from SVB Geoffrey question Porges next Our Leerink. comes with

question. your with proceed may You

Geoffrey Porges

may. you Thank if much. I couple questions, very A of

First, just the restructuring. be and want clear expense I guidance to on the

to I we and increase the you against next year? really in have literally is it launch? said for million if that be or million reduction for for against $XXX to or So, you a the So, $XXX incurred next be again full spend. helpful XXXX the modeling the product $XXX rate after versus about were $XXX $XXX or year clear hypothetical run of Should be it should you it'd year in in otherwise a year million You've -- that. is that then reduction XXXX. reduction we think million a the But would $XXX expense million million $XXX QX saying in could support for million the the was be $XXX million you and planning highlighted what

a would you I'd R&D then source class question. to comments believe FDA internal having their data you in the interested do of to other lastly, consider of HIF, -- your Second JDE Are capital in effects identified were signals your fund all the -- monetizing the for you China or be And molecule investments? in effects? the Thanks. studies seen your that the competitors' as

Enrique Conterno

Very good. you. Thank

address Let class. then basically also and I'm question. to to your ask around to some to going me try first monetization, you we'll product of China comment, marginal or go to two are other signals Juan and the the that whether first then the questions had

think of -- terms cuts we what provided guidance the First, projected around guidance today, I expenses. to in basically relative was

are having eliminating Now, that, we positions. said

yes, think So expenses. basically for. that, our be headcount and going I we we have mind some projected and lower in relative as million basically potential to to to account expenses $XXX are readouts means launch, to to additional Keep expenses. get is we will by is that the the that pamrevlumab definition, we have that lowering closer But a

comments able to the any that you to more make want color the this any is Our not stage, we today to that. to do be do but at to want do able to to when want as guidance be resources you U.S. it additional the comes and FibroGen provide on have operating to launch pam first sure Juan, point? aim we in expenses providing on We're that? make

Juan Graham

think explained I well, it you Enrique.

prior of Geoffrey, to is Enrique the I against this as mentioned, CRL. spend we planned think, forecasted what have given our

around of So, the job States. how that Enrique that's, as some of reduction in versus or -- is this mentioned, actual dollars, related through to future our terminations think United in the expenses. there I he highlighted some costs And also think, eliminations our of to number earlier terms right but element

Geoffrey Porges

Okay.

Enrique Conterno

filling few right? were eliminating give over them, last XX we not are to currently positions and replacing positions, sense, not we're months, been you But those XXX of filled. positions. I think we've a Just we the said managing positions, clearly,

the expected is position XXX have, -- of we think a I all, full in basically that are vis-à-vis expecting all positions. we elimination to So

cash for probably that we our have also increased. has seen, have You year -- Geoff, the guidance

reduction. it $XX relates in increase the Some directly to of timing, cash about but expense million of is guidance, it

So -- course, of recent. that's, and very

So, China of -- whether for maximize always to When clearly, the to China, of and we how that's -- whether When how assets whether continually I get impact of rest that if that's I options partnering, what something partnering, could thinking the thinking about we that always comes would the it's pursue. about the exploring. the lot asset. more to of -- example, is an about it's or always pam, that's we of case thinking it think we value basically China about in it think -- do, a for provides already having the partnering. value the the for I is our on about operations it's year. to can and And aim all we're Clearly, us know questions of we're and value something that maximize

clearly, the are to I Of all in that our is our could thinking mentioned, is to we about we FibroGen. is aim that it But maximized. of ensure course, the assets value as of basically always launch as U.S. do what

on of additional the the data. Finally, question some on a -- quip your

any against large go trial, basically and to events some adverse going chance matter very different you. a were I -- see difficult you when events of but are in basically signals start These say large trials that think low are of products. different whether just to it's seeing signals in signals the always are a you are matter

right are some signals I end and to whether And say ask the what to going day, think are for provide Some some are the Clearly, that it's also be Mark in I signals not. going very needs to take more we're or against of tell. safety the ones go of additional released now, my at to to question. you. But seeing products basically the to difficult data going I'm cases, you. some last comments the I those would across go think think time

Mark Eisner

versus the dosing compared trial makes think choice It for I non-dialysis was mean, an placebo competitor, active I strategies, to Enrique. in differences roxadustat of are in designs, comparator. there's population we compared Thanks seen a draw example, to the a daprodustat it presentations line top a principles also data generalizable the know publications. And there and very just based yet, difficult we've molecules. very about to lot on class versus in don't

very a don't question, have for full answer but interesting So, I you. we think

Geoffrey Porges

Right.

Thank Okay. you.

Operator

comes Thank from of Jason America. next Bank with you. question Gerberry And your

your proceed may with question. You

Unidentified Analyst

for taking Hi, Perry our on for is the Thanks this line Jason. questions.

First, Could to just understand one a in a ESA CKD of has your in on takeaways related I'd there like roxa details forward impression the What focused dialysis-dependent the And how CRL. your the roxa to that potential path CRL? for guess, the the informed main of I focused U.S. be or market? follow-up for hypo-responders? then potential trial patients non-dialysis-dependent either on question. And have were

Enrique Conterno

question. Yes, I'm address going to have this directly Mark

Mark Eisner

Yes.

question. good So,

to soon. going working with Enrique the FDA be meeting forward path are the said, As through still and we're

proposed we from committee, the could different a lower be you'll strategy and As a starting that molecule. recall path forward our advisory dose for had a dosing

to we're explore something going clearly that's So, FDA. with the

mean, the a broad we a to both specific achieve achieve are point to discussion DD label how That's FDA intending study and I populations of In achieve we terms in label, a of includes order we that. NDD. to can with still the still that about that need exactly

Unidentified Analyst

it is other? then Is growth other at one trends Is adoption over one in the for I China around from the level? predominantly roxa -- be color in would XX-XX related guess, between And Thanks. dialysis-dependent, it Any is indication where non-dialysis-dependent? helpful. Okay. CKD coming to just the

Enrique Conterno

seeing lot market a Yes, more coming treated. treated both, only are for market are seeing growth with clearly, you when we Most anemia clearly, patients NDD from actually but is right, if clearly, patients with referring are are DD -- we with to market -- being all growth, are expansion.

level. So we that's made market the a point at that

that's most is is continued that, innings opportunity million are revenue view to NDD roxadustat DD going that something this coming role have coming opportunity still from out. before, China. huge, from I in first for see play level, in playing do we And very we of Maybe DD. and be we as coming to million about roxadustat with asking the is At roxadustat in as about expansion a think, said leading $XX China. a longer My you're opportunity the If specifically, revenue, in think significant is for the we that of NDD. our term. I from market The and significant -- $XX

Unidentified Analyst

Thanks. Great.

Operator

Thank you.

Your Paul next Goldman comes Sachs. Choi question from with

You your proceed may with question.

Paul Choi

about on on you Hi. My taking update just, of afternoon. Enrique, is questions. are key good reimbursement cadence you our Europe? to years, then thinking pipeline factor how one that's I follow-up into thank the us over given that, and Astellas question you a Europe. partner And two And gating And the question. and your in next Thank trajectory first there just And establishing had about the for you launch maybe a potential thinking how can geographies? you're

Enrique Conterno

general a make I'll Yes, comment.

be are specifics as and Europe, the other those what of launching markets comes in markets is once Germany you allow think directly. you generally, I agreed questions you asked in when questions it answering to think Astellas what know, But be Europe, to to I need basically they're basically those temporary just going we've as called launching to a I have markets. is you that And reimbursement. get then you think price you are like actual launch in with that

U.K., the And is, launching that Astellas be country now level. markets, So, reimbursement basically staggered. that of And four the at granted tends know Europe. the are that that in the Austria, is but have to in four I Europe, course, and mentioned, the addition to can I -- in that, working of Netherlands, just that they of they course, diligently across reimbursement ensure to countries Germany

Paul Choi

the been or you second, thinking about you maybe -- And on pipeline. Can Enrique. us the just is for didn't in on the of where XQ something here follow-up, an update Okay. Thanks roxadustat just deprioritized? how that, as for development a that that's you're indication are it And CIA. with your just slides. I mentioned then see

Enrique Conterno

program. CKD that that a footing positive anything No, CIA, are with I trial. and we to not but from thank getting solid FDA and discussion on are we as about how informs the question. matter think your it's for insights the The CIA we is also the Mark, of but it anemia around we you data, data forward -- that to we It's ensure think that think want prioritization of because a about else? looking for the

Mark Eisner

to CKD for mean, and our the add, trying is as I us we're as forward AZ path main much forward said, now for is Not well. path parallel that a find for one CIA in establishing right Yes. you then discussion with Enrique. to under and

Paul Choi

you Thank much. Okay. very

Operator

you. Thank

from comes Hsieh question Blair. next William Your Andy with

proceed You with your may question.

Andy Hsieh

taking my for Thanks Great. questions.

the collaborations reorganization internal understand your have. candidates or So strength or reduction reconcile -- you is, that We're external differentiating? the seek how and internal obviously and trying of you the is one to just R&D also highlight kind of desire or that plans pipeline Enrique, can between to expense

Enrique Conterno

question. going I'll Very Hunter good. then to start, question. very good Yes, I'm that and to complement ask John

think I But very the I think research that But item we D. program. run about as R we can ensure line that think the line hurdle is your course, about about -- is when as do process. to hugely also at that, we it our and by think of innovation, part every on raised on in -- how to important if of your a single taken look on exercise, including the focus as this efficiently we've area a think we've we comes every answer had that the is and focus of clearly, to the And of we preclinical as item than close the trying -- company. is -- part question more more

certain number best There are believe the also years. behind. internal additional programs and moving ask, is HiFiBiO I'm some And you few There we're forward, products collaboration, ones from we're like our So, if those we that which, as we've programs comments. there is a a next are clinic products. mix are have external. that going the to the But make make you'd within that John, to behind. basically to it investing we chance investing then are of the mentioned, to of targeted basically

John Hunter

path been that are we projects of around new of programs, over forward we're HiFiBiO the well. focus been by years take out have we were of full expertise brought up the that there we consolidating the advantage that clinical move have therapeutic of as only company, areas looking in we're coherent programs. around set really initially with the at have so that building I programs. where the preclinical add with them expanding existing them And new also expertise FibroGen, looking a developed And to but clearly, forward I would really area our kind but of with it, need of the areas a programs Sure. that the expertise to outside think and

Andy Hsieh

Great. and Thank question really are look that curious the process at prepare, think Chinese they they comes price, towards if about point. look follow-up you. coming the best position educate it related a they on to this renegotiation do When curious the they at on into Just with can to maybe do you evidence, I I'm the negotiation potential year-end value price can real-world proposition? just the thinking. about us how things period. you government renewed up process at to how heading leverage have FibroGen

Enrique Conterno

is it it negotiating China, the when it Clearly, world is with case and the for payer any Yes. pricing. to case around the comes in

the then to, this price, price products. happened, course, the know, the are that the think In the reimbursement you and for reimbursement two paying brought basically is every product interest right? China, has set. as of across years think government that a years, product is same that meaning how discussion. garner functional are impact the this clinical competitors, And budget the is in Everything of successful have of just being, products part product of or countries, from competitors the neighboring they to the attention. value more competitors, class the as whether than number I because prices. mix also, to success -- lower a the also of board I the direct basically in the is the two every on renegotiation NRDL are number into every the new factors product, it's There of So a price has significant price,

combination a there's So, factors. of

month is think right, the in all that their important, something go for going products ensure in us, industry that terms I the are to And going think this of basically to is it reimbursed extremely products including discussions, basically that's be NRDL. the across forward. to I right,

would So, much and provide, more that's not if sure maybe can the I I'm I that add I to know frame answer that. don't that your question.

Andy Hsieh

Yes, that's helpful. much. Thank very you

Operator

Thank comes Our Cowen. you. next question from Werber Instructions] Yaron [Operator with

your with proceed question. may You

turn If further you for Enrique on now call line I to to back any And remarks. unmute. like mute, would is over the please

Enrique Conterno

questions. We day. in thank very in interest much your No, appreciate and today's investor call rest the for participation your very you Thank FibroGen. your you Enjoy your of much.

Operator

participating. Thank conference for you you. This Thank concludes today's call.

may disconnect. You now

FibroGen (FGEN) 10 Nov 212021 Q3 Earnings call transcript