FibroGen (FGEN) 9 Aug 222022 Q2 Earnings call transcript

Good day and thank you for standing by. Welcome to the FibroGen 's Second Quarter 2022 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Tung. Please go ahead.

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

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

I external kidney the programs novel the to the FibroGen for path Graham, leverage will to you, while of and welcome Mike, the Pamrevlumab Thank muscular in Number chronic success And we roxadustat with expertise positioned accelerating cancer of and with level US. that three pancreatic to a in earnings afternoon, of continue IPF, internal XXXX three, our and review of locally productivity with or and summary high shareholders CFO, then will medical LAPC, in the dystrophy open a accomplishments is good. financials, and quarter Slide or resectable Number development developments advance most Juan our Starting quarter the Very disease pipeline US and focus. explore of needs, significant questions. outside call, XXXX. ensuring research our and everyone, for increasing will two, forward idiopathic one, good call. second on fibrosis number significant On second unmet Duchenne value X, provide DMD. pulmonary or advanced accessing for patients call today's areas patients three create after by executing additional commercial to opportunities. which our your indications in the innovation important

unmet these in is indications, Phase wholly-owned high trials medical IPF, a and of significant each pembrolizumab each with asset Slide need Let's a opportunity. represents Pembrolizumab on and value DMD, move LAPC, important an market for one to our clinical clinical trials constitutes X beginning X. three diseases

we trial pivotal patients fully pembrolizumab LELANTOS-X trial clinical Phase recently completed X to four. the we of quarter, number pembrolizumab the ambulatory trials Zephyrus-X the of during with in enrolled second the DMD. The and progresses. ambulatory of in LAPIS updating enrollment announced As continues This as Phase LELANTOS-X non-ambulatory DMD Zephyrus IPF, forward our look X IPF trial trials the and respectively, LELANTOS-X in the studying we in and second in Enrollment and you LAPC. trial brings to

second Moving Based delay analysis survival as set be us was file approval. for high conducted independent of analysis, cancer, third quarter. the An interim have we the previously enabled we study a locally discussed, free bar event for advanced free to will for approval. survival that LAPIS now a pancreatic accelerated Phase very to on would interim in not a X in the event filing

remains number if PRAISE with sentiment options. of Phase desire a has therapeutic and trial, to IPF a the market you given additional results and believe Slide the pancreatic cancer exciting in major of the prevalence survival There the IPF study XXXX, rate two Pamrevlumab Phase highlighting half continue primary therapies last opportunity Zephyrus-X in planned, overall setting have demonstrate need as areas X There each XX,XXX the potential a the with data column, disease and respectively; to with $X with the size, LELANTOS-X trials a in perspective of in the similar of LELANTOS Phase the approved Japan, regions challenging low data can I'd is generating XXX,XXX two over Phase Pancreatic in trials progression the first we XXXX. therapies will few see two for the one of in significant treatment we around significant very program Zephyrus the therapies limited the with the is be in is In X of the largest late-stage first diagnosed China, X demonstrate failing opportunity the disease locally almost very be survival patients a MDS EU, billion a reliability. to survival endpoint by five-year There Phase cancer approved in to expected It second medicine unmet continued patients beginning can XXXX characterized the patients opportunity. the non-metastatic now in Despite XX%. of meaningful therapies of Phase advances current pivotal significant of readouts over from topline XXXX; revenue the mid IPF. IPF, diagnosed combined a disease-free and commercial care. on over Matterhorn improvement for standard in significant the across As middle four limitations X half survival. three spend IPF see prevalence in the with immuno-oncology the development it like needs in creates cancer, If on advanced With first net X with oncology current these overall decades approximately represents of there a represents XXXX. half for which across of community help benefits trial with US, to in Pamrevlumab Pamrevlumab opportunity its X of with significant activity its minutes in trial and been for in limited non-metastatic -X LAPC the and IPF both. roxadustat the and of DMD, half in in the the a the unmet X pancreatic produces sizable XXXX. XXXX of commercial expecting

finally, the a combination continues the section in networks' the pancreatic the addition, with to in pancreatic promise patients of And opportunity. wrap cancer of action evaluating platform snapshot third DMD the for precision care progress. that cancer market In standard Pamrevlumab metastatic with we up column, with Pamrevlumab

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

proportion families. are by progression be While the prolonged improve to solution We the that the downstream changes anti-fibrotic exon-skipping the clear patients approved There mechanism and of their dystrophin to at a therapies believe ambulation. they help is levels, the increase disease Pamrevlumab need an DMD targeting for can therapies of function patients. in have muscle make targeted currently that small may these a pathological and produce

in believe Slide approved Evrenzo be in recently on dialysis. Astellas the X. recently significant. Slovakia, approved Sweden. not mover is numerous Now Europe, Finland, advantage of South countries Europe for on opportunity It Africa. EU anemia to relative and With decisions CKD an approved now in was and China, and important U.K., and roxadustat and the Japan, in CKD We HIF-PHI's other countries has reimbursement roxadustat in let's the Mexico other on dialysis patients the additional is of move in first continues received and to positive to treatment

healthcare from in expected Evrenzo has been early Our where the providers has feedback The EU initial than has countries prescribing uptake launched. positive. been Evrenzo slower

partners, in we of the earlier, development continue noted AstraZeneca and roxadustat As with Astellas. MDS

continues Moving China, to now its performance. roxadustat strong

NRDL. Slide total of distribution volume compared price reporting driven XX% XXXX. sales in FibroGen the the X, are an This and China to million joint As reduction by $XX.X second over million quarter you we was of can the $XX.X see the offset entity, of quarter roxadustat on second in by of increase net benefiting in from

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

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

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

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

Enrique. you, Thank

for Before would with our patients challenges, results highlight to quarter. CKD my the outstanding continue jumping to remarkable put financial anemia enabling effort China the by remarks, into I of they the the forefront in do, at COVID financial they despite like everything lockdown team

As energy and dystrophy. and from passion to pulmonary have patients take build we on Enrique, time the we day-to-day continued cancer, execution thank also unresectable to idiopathic which want suffering to our enrollment impact and trials momentum Duchenne muscular move fibrosis, on a forward pancreatic significant clinical clinical hope advanced for our our I for colleagues mentioned Pamrevlumab. by some to trial locally will

in in period XXXX. revenue Now compared XX% represents sales million net recorded getting China for are financials, to follows. sources growth product $XX.X revenue our $XX.X of This revenue into same to the of for was $XX.X as XXXX. of quarter million for of million Breakdown compared quarter roxadustat million second total the quarter-over-quarter. in We $XX.X the

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

the co-development as development revenue stage of coming in the expect in roxadustat and reduction a we Given anticipated, quarters.

of JDE was related revenue X.X FibroGen in resulting in AstraZeneca total operational quarter jointly NRDL roxadustat to product is to $XX.X net in the this into of million in joint this roxadustat compared ingredients drugs or Diving the to to negative compared to million due XXXX. net by in Finally, a results deeper entity It sales sales drug the adjustment noting roxadustat year. or quarter we million from $X a business distribution net same gross recorded the sold that one-time a worth owned $X.X to the $XX.X second China, pharmaceutical period quarter reduction active last million price. and our Astellas million adjustment distributor sales include as new bulk of for

NRDL Excluding is over sales this X%. the growth sales impact, volume the of roxadustat QX XX% underlying XXXX renewal. price a significant Further, XXXX offsetting increase was result performance versus the of

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

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

this $X.X During in to estimates million deferred per due change the we future GAAP. as our from revenue US released quarter,

balance we As in the we based have future in revenue revenue. communicated of on estimates deferred quarters. fluctuates future the of past, It expect worth release deferred is China highlighting FibroGen further in revenue management that

the sales million a expenses and and with clinical to distributor down our decrease China. quarter to XXXX. inflationary in incurred million trials Making in from were $XX for in $XX.X $XXX related operating partnership of FibroGen overall costs operating and our JDE recorded for expenses This in roxadustat from infrastructure, associated to million of costs the quarter way million net supply direct year prior is compared to the result the a the one-time As P&L, revenue sales Lower second $XXX.X driven cost R&D our in FibroGen by with million our our programs drug charge including pressures. efforts period. Pamrevlumab X costs Phase management HiFiBiO $X.X with

second receivable. cash, XXXX we last the quarter XXth, efficiencies, million $XXX.X loss and unlocking or diluted $XX.X and investments, in investments, compared $XXX organization. is improvement of cash, million. quarter per shares equivalents, as to and both basic reported We guidance. was well the At $X.XX ending ending net million through significant cash million and in $X.XX been initial second prioritization XXXX, has as $XXX shares investment execution, $XXX cash enhancements, net net the accounts million range June loss as a of to balance of During throughout year. of be This our our XXXX basic equivalents, driven accounts loss for to cash This diluted or receivable to estimate the for improvement

consider, position our offering. prior I to I with time. refreshing equity strengthen through prospectus my have we Pamrevlumab As will and options supplement an in our readouts privileged for we today, key mentioned conclude at-the-market are we're to filed opportunities have wide continue we appropriately by that as we S-X array look financed mentioning shelf remarks financial of data registration are statement to or a over initial quarters, for ATM cash believe a as

the financial now as ATM. plans utilize and over good view corporate Enrique. take management. this a back you. to have Thank We no the call to near-term housekeeping And I'll We turn

Juan. trial LELANTOS-X trial Pamrevlumab unmet three you, medical significant muscular We in Zephyrus-X X in XXXX in well to the X in Phase very closing, idiopathic MDS. in in potential DMD In Pamrevlumab, fibrosis, roxadustat, expect advanced a to data medicine first-in-class continues thank China. X perform non-ambulatory topline and trials and cancer, Phase locally dystrophy. from and Phase pancreatic as with Roxadustat Duchenne development well ambulatory Notably, resectable respectively, advancing we and remain as Phase X needs, committed indications IPF, and as LELANTOS-X MATTERHORN in pulmonary

approvals with is addition Our recent and partner in Astellas moving Europe forward regulatory regulatory in commercialization of roxadustat the submissions review in have geographies. additional we under to other

to have million position strong $XXX million expect $XXX.X to with with cash. XXXX continue We to cash in end financial million $XXX a and in

long-term options consider have sheet to multiple ensure success. further we our our strengthen Additionally, balance to

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

with Jefferies. first our the Michael [Operator Yee Instructions] And question comes of line from

Your now line is open.

and looking study? you're reading DMD there with at it, can out, about Thank you can any you it's or Thank has us studies initial analysis or well? interim you about if DSMB update. is well you the looking any study that study LAPC appreciating can And what to that questions say at, are going the you. tell interims interim had the the past ZEPHYRUS-X studies two as IPF for those on as what is the say We on continue, what

I'm Michael. answer you, Eisner Thank Dr. going your to to questions. ask

it. the The is for including answer interim DMD. or no for analysis your Thanks IPF Appreciate questions. is any there studies no, further of

are no safety, All of analysis. DMC course of monitors independent planned but them have interim there

one FDA of these have on this a you Thanks. and endpoints be sort you is endpoints what what successful is DMD data final show travel there novel appreciate to need with as question the study? required with studies, talked and and and path, Okay follow-up, your deemed to

Yes.

and have we So, non-ambulatory ambulatory do endpoints the for studies. both

Assessment, measures North of have both these DMD The We Star patients. the is FDA. those the the for ambulatory for Ambulatory and performance limb standardized endpoint types non-ambulatory it's with for score the are discussed upper of

approval. there So, we on based a efficacy forward these expect that if filing endpoints for would an we path demonstrate be that

you. Thank

with the line comes next of Annabel from Your question Samimy Stifel.

Your is now line open.

this Thanks is in taking question. Annabel. our for calling Hi, for Jack

the more current available, For should the how Thanks. you what little provide the think could of you are expect in those treatments color treatments about pam, and the a IPF that? we how context trials opportunity eliminate to around allowed on background in noise

a design pam. Very good, would about question, opportunity our that discuss and to we thank share trial ask Thane you with for and we've to for the have about learned to I'm Mark what going bit IPF the

All right.

treatment-naive monotherapy pam We they study, treatment is X treatment-experienced not versus it for on the they're so placebo Patients placebo-controlled of trial. Thane? patients the on ZEPHYRUS when either they pamrevlumab, pirfenidone to background are trial not So the allow do when trials the be therapy or of Phase and IPF. the enter program of but on nintedanib, enter trial, both a design. it's for

Mark. Thanks, Yes.

of commercial there's So in as things to the about opportunity, I think a think keep couple mind. we

to is IPF. Phase were seen of X able in trial. X PRAISE First the we with that patients ZEPHYRUS treatment we've in pamrevlumab an for for what indication program our We the would replicate Phase expect

with related end stopped who As it to the based both XX% the the have and care, literature, we those upon Esbriet, taking it's that this of of Ofev and first published of investigated standards either on to is of pretty the state of year. clear, current tolerability start have patients the upwards current challenges given by XX% associated therapies

the and on at need, look And disease patients that demonstrated or that but tolerability the a as Ofev a relates could efficacy but we not again, product two either PRAISE relative Phase also data so tolerability available profile, therapy. not reflect keeping the to only there's progression, really to relates pretty therapies. it we profile on very against think it got as to to only a we've unmet X if Esbriet, significant we're head-to-head that we significant not a lead differentiation confident while And, current

And Blair. your from Hsieh next Andy William of line question with the comes

open. is line Your now

of that, very Thanks from derisking like Pamrevlumab, so, futility and both do one at the curious also my on road? trial was was than hazard the Gem/Abraxane only just of variety when and first the to questions. And that an Okay. about analysis down or -- appreciation added, FOLFIRINOX study analysis, XXXX Pamrevlumab. Thanks futility when clinical how analysis, EFS continued garden it's two the the and China the so initiated my with the OS? the lack kind is also question for robust I also progress analysis looking with last get one FOLFIRINOX just how included, of I'm or has and -- on the might noticed has the the to taking congratulations first for trying design. study. I have to second a integrated questions, the with more that in questions was launch taking launch, the well So, affect greater about is subsequently ratio that than I'm do futility incorporation my China primary

on therapy Mark questions as Andy. for you, trial. of FOLFIRINOX on analysis have and LAPIS then accepted the futility your -- answer the background background I'll for that Thank of incorporation both

Sure.

analysis our was so primary filing, independent and based the as remains trial. are efficacy for the on that the overall analysis with conducted for survival supported statistician actually moving look we're forward have early event-free an which could we was endpoint So, that accelerated the to that and planned, endpoint of survival --

really moving we a need on wasn't unlikely early we we free as that interim we base analysis would free are event which given we've and for the did efficacy an desperate said analysis was endpoint show it among planning. and did of what high of this in that this survival event need thought high based at surrogate forward hit much previously were we look EFS case it the cancer therapy, to and futility as put unmet OS, on was, very the medical a as crossover pancreatic bar the But, with call very the So, it survival patients place. we the in was our

In Gem/Nab you're the right, terms design it of well. it FOLFIRINOX now was -- the and quite allows as also for initial allowed background chemotherapy,

that patients so on think commonly the chemotherapy. commonly by of favored top So, regimen, on a third backbone we chemotherapy rationale trial placebo it's a about both particularly is is versus into allow of Pam surgeons, chemotherapy of background this was oncologic important prescribed are these for regimens FOLFIRINOX chemotherapy. I to The the thought is it used of on

to subgroups be and both individual will overall both look able at with So, backgrounds. of population the the chemotherapy

Werber from comes the with of line question Cowen. Aaron next Your

Your line now open. is

of Hi is Brendan on for guys, this my Aaron, taking thanks question.

much. that with now, do regulators do therapies? paradigm you maybe considering Pamrevlumab of well. you the studies in remarks curious, from that guess, readouts I I study are I therapies guess landscape know genetically there just and Just remind specific off, there also for conversations through let of your your so the there incorporate next to targeted up they're the evolving your if some therapies related are you exon-skipping maybe additional tracking be questions where us to DMD moving is you maybe the to guess into ahead all subtypes you acknowledged maybe to you couple are looking forward/Thanks I on as necessary and a those that can available and -- on expect patients And know genotypes, I very something just year background might DMD them based us the current to us get come the kind on, more you're any in require in is different different prepared

good. Very

questions DMD. I questions around the address could Mark, Mark. think you those for are

Sure.

and approval, on they're as in think clinical studies exclusion we additional gene of for DMD. care, we And LELANTOS-X additional serve don't of those think therapy, be entering will will basis other not the that necessary questions therapies together not corticosteroids either those or that about the are about an on other be individually approval. then and necessary or will We for could both interesting standard approval. for background thinking but but LELANTOS-X be your LELANTOS-X are patients for be question could terms trial. X, So so down per the studies criteria exon-skipping are our road, initial There approval the necessary for for will we as

next your with from Paul comes Goldman And question Sachs. of the line Choi

is line open. Your now

a on the on Hi, could from plus thank my Zephyrus-X for just status for treatment here reserves questions. Good successful, the QX that for have wondering over enrollment if commercial balance thinking on first taking COVID second had other X during how side completed you one as one just Pamrevlumab, patients serve whether thanks you. trial, your its that many and question performance, the whether but slowdown you you any your may XXXX? status of afternoon our for or basis a update I how is was the forward quantify us I Chris, for the the And can study Enrique perhaps on maybe impact the Phase or about you and if enrollment question about as impact you second is in and filing? potentially you're think a trial, provide

answer I'm ability and answer to on ask question file you, to good. the around Chris the to Zephyrus-X Mark Very and Thank a Paul. question Zephyru-X price, going China And first Chris? the to

I roxadustat uptake of China we of market background available not significant half first us quantify COVID, seized year about the the been you for not us the our advantage. of have for volume, difficult is decrease. had information, believe, revenues however, Obviously, has a to impact publicly very administration is if way It for there due is you in it COVID. lost have the XX% in net-net this an question, as roxadustat and I first COVID on just is -- Paul, asked performance, the a what Enrique. the to on done, half you, so Thank oral believe to seen they disclosed average the for multinationals tell generally, what a this Thank for you,

it. suspect we from So, we benefited

out XX launch came AstraZeneca executing three market momentum years NRDL very and of also more had that between price for and We of reduction are generally, experienced almost and accounts we well. the with who the tremendous after FibroGen, now, and uptake,

would on the good things tell going very COVID, the year. we more would have done I obviously results continue think us, second pleased to good it's to for there So, and positive side, but how of hard many bring were half with the we're you topline in -- me those just I without much business don't the mentioned for factors us

Yes.

provided our there. when we enrollment we're Zephyrus-X, for and guidance Pamrevlumab progress are have So, complete, not on making yet anticipate very about we to good very we but excited efforts

data we have X to strong as base the that if with we've file. FDA that as trial potentially be approval In suggested. terms Zephyrus-X said, before, first, -- needed of I Zephyrus-X would be think filed Zephyrus-X with you we we study could strategy, said whether coming filing be PRAISE for an Phase our case is those and With will initial because data will explore the Zephyrus-X

very Okay, thank much. you

comes of question America. with Bank the Jason line last from of Gerberry your And

is open. line Your now

for my thanks Hi, questions. guys, taking

perspective? pan you out, over your first one to then ambulatory, of I in would just of it not Just another the if missed but get stated the risk And on work roxa, two working, -- separate to versus that separate views, sort how DMD, the from non-ambulatory filings of are apologies the past, basis the at populations like this, potentially if shifting I curious is wanted the non-ambulatory two maybe trial where that work higher through NRDL just kind have with just impact, we higher you the a growth we of no ahead the comp commercially of to volumes of period NRDL as year dynamic think one think on offset expect Thanks. cut, smaller any that you you that a with, helpful? cuts deal or perspective are NRDL that relevant do with be successive to the each get if you would have or your analogs

question about filing Very that China to first, and results. question and LELANTOS-X good. I'm of then the and you with one, Chris independent have the address start going based on potential LELANTOS-X don't Mark, those we Why tackle the can

not understand make due expect we the So, state part about cut specifically, calendar industry which believe a want years about did question price XXXX. range, current first question to correctly. subsequent the of the experienced what NRDL lower I expects significant, first but the generally, the we be uptake in the I is of volume we so to is Roxadustat the whether We talking to sure cut price and in the that most cuts NRDL

get pricing variety We on have budget every to and disclosed can the to cut this was of cuts were publicly diverted COVID for tell conceal will many the factors, Subsequent you allocations controls. year, NRDL. the because price that are XXXX first a you into price is significant change certain amount single dependent rules on

hard we we it's if much it it to general how predict, on I factors, price next smaller hopeful be that's rule, the cut in time would but The hard would us than than we uptake national competitors for, a how depend actually we time, with question. our our experienced of predict experienced. volume cuts but So next will a pricing on answered we take. just decrease the as that to just variety the hope your past. hope ease would what of is I be cut budget certainly less would what of pressed what much and we're actually at that the

Thank you. Yes, that's helpful.

DMD. your And question then about

question good really the a population. and it's about think non-ambulatory ambulatory I

filing, new possible. ambulatory either together a so basically LELANTOS what We'll would need as so unmet we're their so are it's to the need to discussing actively we data as therapies positive chance data is evidence patients they -- try parents depending but first, think non-ambulatory the expeditiously do everything on a that biomarker could of and have than improved any hand have If data. clinical of something the I with skipping LELANTOS-X at in approved therapies LELANTOS-X internally. coming besides approved non-ambulatory or see and get here from is real data studies course, think the filing strong, If desperately today possible right show, high that are we you the good on the alone the or very data think -X I biomarker, deferrals about support

I no see Enrique to to the at turn this now conference like I over further And time, questions Conterno. would back

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

This you for concludes conference call. now may today's participation, you your Thank disconnect.