FGEN - Earnings call transcript Q2 2024

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Operator

Good day, and welcome to the FibroGen Second Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to David DeLucia, VP of Investor Relations. Please go ahead.

David DeLucia

Good afternoon, everyone. Thank you for joining today to discuss our second quarter 2024 financial and business results. President FP&A Vice at Investor DeLucia, FibroGen. David of and Corporate Relations I'm

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

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

Thane Wettig

overview your call with metastatic with as treatment late-stage the recap which pancreatic clinical results to plus meet for compare our Dave, updated announced for focus call. On opportunities Thanks, it. Juan the plan Slide patients which adaptive did in will our Officer, The will protocol FG-XXXX, pre-specified front in provide Dr. highlight Adib, data the call, the by trial, X, study ductal of trial endpoint we today's first-line nab-paclitaxel, our will pancreatic our statistical alone conjugate, nab-paclitaxel about treatment determined go-forward and I recently gemcitabine gemcitabine in Bayesian imaging Deyaa review questions. On analysis. open the pamrevlumab from I on targeted drug good and the to earnings we for has and CFO, agent company FibroGen the XXXX an with we so of strongly a prostate the experimental quarter attractive Phase in Promise II/III like survival associated and everyone, overall of why the cancer the combined pamrevlumab the second welcome primary Phase Graham, adenocarcinoma. in platform Last provide that of PETXX arm cancer. landscape, our and of PanCANs, prostate Chief castration-resistant plus Precision week, would pamrevlumab will second-line Medical development strategy discuss the afternoon, recently of metastatic I X and not released results. financials, top-line the And arm antibody after pamrevlumab articulate feel top-line cancer, CDXX stakeholders reported

to prospect would trials. Due clinical needed first-in-class and significant for therapies for that meaningful FibroGen the result. to affecting Duchenne patients with We highlight the not III prostate cancer, FibroGen these hopeful a time thank which compared Specific in gem that other the like gemcitabine as dedication pamrevlumab headcount plan, in in plus was bringing and patients gratitude to pancreatic several to dystrophy, would with cancer LAPIS difficult or challenges the FOLFIRINOX much have substantial to nab-paclitaxel mechanism Precision This unfortunately, by and top-line my data after more as investigators treatment trial as that with the solution from cancer, FibroGen patient graduation some the FibroGen-sponsored combined and both reduction announced FOLFIRINOX diseases deadly be or diseases their XX%. combined demonstrate We Phase pamrevlumab placebo like which trial, we plus need of also of nab-paclitaxel to will locally Slide and of to I advanced U.S. unresectable will little humanity. On development, with participation and energy at company productive to the live is lives. a advancement trial. to pamrevlumab The challenging pancreatic platform a idiopathic Promise for includes knew X, approximately treatment into diseases; stakeholders, muscular who enable deepest dedicated outcomes cost I Phase unmet past pancreatic patients targeted were colleagues primary from and the not survival. When pulmonary the also well overall III our has. exciting the X fibrosis, would with that implementing express the learned results, would to cancer. simply very we advanced much X over a for so years. Most Stage adaptive a the longer X especially most we FibroGen pamrevlumab -- not like to did overall endpoint study reducing benefit, associated pancreatic of survival unfortunately of meet their Stage assets the

enzalutamide in of targeting Phase development in June, an trial for FG-XXXX with and of trial more first-in-class quarter combination the Deyaa other and was detail antibody data II I XXXX patients combination of Annual our targeted preliminary I prostate the mCRPC. we potent call. in studies I/II additional these PET portion associated FG-XXXX In the the of Phase XXXX. Top-line in at of Phase released solid Meeting. the XXXX X in data program half the a CDXX of catalysts in II Phase imaging data the also portion of on and in compelling initiation Phase for escalation X the April, monotherapy dose FG-XXXX, agent. first cancer conjugate drug castration-resistant combination will ADC, investigator-sponsored data monotherapy is from first compelling of treatment from This We metastatic FG-XXXX First or study presented CDXX includes from XXXX. trial ASCO potentially tumors. the provide anticipate The with later the the the

XX in to Juan with from sales generates under Astellas strong and significant Due million. U.S. to $XXX over and our GAAP in product cash $XXX and -- now million up our million full AstraZeneca in to million, cover of up to in provides our $XXX FibroGen's raising more approved roxadustat be $XXX call. net XXXX. year Pharma. the year million, is Roxadustat roxadustat. through for will $XXX flow expect net FibroGen to between $XXX million with year roxadustat financials from material China $XXX guidance and previous of full $XXX positive are economics in is partnerships countries, revenue we guidance China, net $XXX and detail revenue Second million We performance growing our full later million million and

roxadustat meaningful would decision are anemia, represent anemia We in from in which, approval authorities substantial an approved, chronic by chemotherapy-induced also XXXX for second with if top Chinese the on kidney the revenue expecting the of half generated associated of revenue disease. growth

Korea. has in the to excluding anemia the a high number this China myelodysplastic partner U.S. presented FibroGen from AstraZeneca partnering opportunity opportunities allows remaining for the South on Earlier Next, with the and in lower-risk data ROW pipeline. with we of indications such and certain to unmet roxadustat syndromes. Based year, in This patients regained rights as at our needs, us territories, roxadustat potentially we last with unmet in who placebo represents III a trial condition in higher lower-risk is substantial demonstrated opportunity. commercial year, an Phase with transfusion a of which trial the burden, MDS, focused independence patients significant and a entered which MDS, excellent with difference transfusion roxadustat a anemia candidate a a ASH need for meaningful believe in associated between roxadustat lower-risk December in with

Second, the immuno-oncology to of we we development for licensed X stop HiFiBiO in a internal decision have made difficult programs XXXX.

Given programs deserve. simply advance the organizational we don't as last they week, have changes announced to we as substrate the quickly these

and about potential the excited programs for these opportunities there of these be assets. both are continue of partnering believe We to very

important Phase product made IND clearance monoclonal antibody, including have I receiving of the these and the optimizing programs, derisk anti-galectin-X FG-XXXX, be to our for ready. affinity enabling to We advancements

it where activity of the to made We monoclonal best-in-class has progress advancing potential. point our have optimizing believe it a antibody, also significant FG-XXXX, anti-CCRX we

agreement announced study we have supply in we As LIBTAYO. assets these with trial June, Regeneron signed clinical to both combination also with in of a

We parties both interested FG-XXXX future. partnering the will with discussions FG-XXXX in for and begin near

accounts approximately Lastly is with in our equivalents, quarter We cash, finished $XXX.X the million position. second receivable. cash strong cash and

sufficient our turn significant Deyaa? the Officer, discuss a that to Deyaa Adib, In balance FG-XXXX. cancer to we Chief believe summary, now to strong We call our and expect have we foundation into plans to our sheet future. I shareholder to and creation drive today fund value be over operating the XXXX. into will Medical prostate

Deyaa Adib

Thank you, Thane.

a are provide XX,XXX extend the overview or common late-stage XXX,XXX to of X-year disease. risk became for Prostate Moving in patients therapies in drug the is brief unmet the and ARSI, The year late-stage is of androgen diagnosis landscape inhibitors most unmet is the on the these prostate X, in and that with approximately new patients medical a have have castrate-resistant XX%. like X each currently and cancer need cancer of in U.S. receptor that to States men in high in prostate United would has There the where are metastasized, developing lifetime Slide who treatable. progressed diagnosis a chemotherapy. the cancer in X need signaling rate survival these There significant survival late-stage cancer disease. approximately on I cancer

tissues, development under agent, most an at to in making the entire of comprised is anti-mitotic clinically mCRPC population, the prostate antibody the UCSF. the will development biomarker the validated be a target patient to CDXX cancer linked utilizes ADC imaging composed that PETXX, to will X. the that payload. An of to XX% who FG-XXXX potential selection turning to PETXX company PET disease. accessible potential preclinical that target cancer. FG-XXXX But by Slide development agent, tumor first-in-class and antibody in ADC, the future cancer importance PETXX, expression targeting to superior to is other binding applicable approximately patients the PET demonstrates the due targeting very fact the cells. On that and positive types, limited patient biomarker clinical castration-resistant that demonstrates XX% present throughout receptor ideal cell upon of which associated a achieve pathway is better X, will while PETXX development YS-X, we development specific believe allow binds MMAE, YS-X enrich uptake anti-CDXX IHC We for to highlight Slide treatment the imaging is allow an in and for to CDXX utilizing agent, constituted ADC PETXX is IHC a it as reserved to a tumors. studies in antibody, prostate program. of profile radionuclide antibody clinical in With is prostate is zirconium-XX internalizes believe targeting have FG-XXXX and FG-XXXX candidate. as differentiated We paradigm. population is biopsy same of FDA-approved Turning tumor This CDXX FG-XXXX metastatic in FG-XXXX. of It normal clinical the companion an a to colorectal and

in radiographic efficacy total toxicity, cancer X. progression-free Phase Now tumor occurrence ]. who measurable a who survival top-line escalation endpoints the the the and lines of response population, Slide were survival X.X milligrams results the of until the administered dose I, in are the unselected the prosthetic DLD In trial, using dose baseline, study administered from expansion rate tolerability, were includes Phase biomarker median and as criteria go per of adjusted a observed Phase The completed median capping progression-free objective therapy the an and kilograms at to let's I I disease, measured we arm XX FG-XXXX In levels example, working dose from the group for unacceptable weight component before trial, specific XXX cancer In in by months. monotherapy [ XX-day received the patients a prostate decline of for patients into disease CRPC, were metastatic have metastatic of progression castration-resistant patients FG-XXXX. safety, body X a anti-tumor of of activity treated have or kg of trial radiographic they tumor assessment. The antigen prostate were response of prior cycles. X.X

For partial adverse clinic. in the of PSA events the payload. size I least in publishing a criteria consistent patients. FG-XXXX a plan We in further response manuscript other to with forward data months were the or tumor have in median we conjugate the with profile safety advancement XX% of MMAE RECIST X.X of the as met acceptable totality therapies the of in XX%, observed those of the the than observed reduction drug antibody more of program look months. evaluable an an response that Phase upcoming demonstrated of patients, XX% of duration with in a XX% at reductions

months Phase Moving with currently trial. positive with enzalutamide as escalation we dose only expect run from at FG-XXXX escalation in the number the trial, endpoint is shown mCRPC an least maximally endpoint observed as of for surrogate investigator-initiated component XXXX. We results with study combination of XX milligram milligrams not out component activity of day. believe periods. On PFS patients being excited also FG-XXXX the the radiographic of and or adjusted XX.X in the weight study. in II Other and which other patients PSAXX is PFS kg data of also combination additional announced half X body showing X.X preliminary PSAXX CRPC. We're at that at enrollment enzalutamide. The but the from to biomarker survival of ASCO from screened treatment that response clinically patients, of in in in like PSAXX signals, MTD signals shown Slide endpoints presentation per determination included such results And estimate the Ib/II an II dose that in combination ARSIs, results was Phase is would during patients. metastatic with of XX metastatic study, of has results evaluable at included study XX. a the result XX% prophylaxis announce radiographic prior study PSA which in prior few XX, encouraging a We this prostate combination will G-CSF Meeting. an to established rate. per limited XX% Slide received endpoints objective as Annual of the on a PETXX at this was MTD declining in in constitutes XX earlier UCSF unselected top-line of tolerated a primary the meaningful combination which trial There The Over data dose very or component dose in meaningful to patients enzalutamide the data of clinical with castration-resistant sponsored include cancer. the patients clinically versus interim is stage primary data, XXXX same a a enzalutamide with have The prescription as in enzalutamide. of with these demonstrated with XXX The yet Phase discuss first I from component investigator-sponsored space

care pretreated heavily radiographic enzalutamide unselected PFS with with of mCRPC line, of For earlier is compelling existing monotherapy months of set. an patients PFS the in XX.X combination as versus pre-treated population radiographic months FG-XXXX, in in ARSI very a we treatment X.X believe and standard in

ongoing Slide XX. FG-XXXX. and all for studies the highlight We Moving to recent

generated UCSF year. to this is that biomarker see in for prostate PETXX at in more We progress cancer data are expecting

of As ensuring companion expression patients those highlight PETXX study clinically FibroGen we part therapy from the monotherapy program. optimization XX, proper meaningful the develop goal a dose FG-XXXX. targeted enhance could receive benefit. On select PET selection Slide to potentially and the to benefit by enrichment selection patient articulated, imaging are to for catalysts a patients sponsored with agent FG-XXXX Phase upcoming high II a screening is for of to likely CDXX we will have the and who with be most treatment

are quarter. We FDA the this with meeting

and filing IND file the expect the PETXX top-line XXXX. first a being portion half XXXX Phase with for mCRPC UCSF study quarter IND quarter II in in combination results of We FibroGen's FG-XXXX as next optimization first expect dose in the initiation of from this the to of Phase FibroGen's anticipate quarter. of for as study We run well II the at combination enzalutamide in

tumors of oncology, FG-XXXX represent potentially will forward solid mCRPC action, studies mechanism turn first-in-class multiple an and look on shift novel moving could FG-XXXX a chemotherapy unique antibody discuss cancer such Finally, as you want now with FG-XXXX cancer a across combination a applications other a the opportunity mechanism promising in progress. I and validated of prostate with of The We safety, potential treatment novel and roxadustat. payload. offering beyond also to to We but target Thane only efficacy, a a represents. as updating to potential colorectal novel with in summarize against that treatment not call Thane? lines various offer a action the to cancer. XX. represents molecule enzalutamide paradigm opportunity back to bearing Slide FG-XXXX types. in may

Thane Wettig

Thank you, Deyaa.

XX. Slide of in well for kidney disease continues Roxadustat to Moving now to China. extremely anemia chronic perform

on FibroGen sales increase the by $XX.X $XX.X million of million an in was quarter compared increase quarter FibroGen increase product totaled XX%. U.S. XXX%. to for in of Second second of entity in the FibroGen's China in of an volume AstraZeneca, XXXX, XXXX, the portion This by and of in net $XX.X compared basis of XX%. roxadustat quarter driven second GAAP the million and distribution China net by total million a was owned $XX.X growth revenue an jointly quarter second to roxadustat

Roxadustat China, important China. share Slide category roxadustat to new in ending addition and on would XX% business continues to treatment a in for anemia addition anemia an Moving a indication chemotherapy-induced the maintaining share its the the XX. and May value most potential chemotherapy-induced provide XXXX. brand X-months meaningful The patients of period of leadership in recent alternative with

in able revenues a in the after composition-of-matter [ volume-based Despite the China not of the than face of have lead market. market China historically of expiration in to Given is the products I China generic time least U.S. a in applications filed risk approval expect in the roxadustat. maintain hospital Generic roxadustat the includes dynamics meaningfully several do execution need and the applications approved the The do are until experience launch of to X listing only market as profits not been that the been products ] deterioration impact China, after our then, June reiterate originator they stream there are of and after at subjected generic in process. Even patents meaningful into the near term. one revenue market. the meaningful occurs and be approved approval would players in generics we to XXXX, exclusivity time. individual formularies VBP purchasing, of of like and originator which Originator net in products at X have a generic a and adoption they of different admitted to enter business in deterioration generic and government

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

for in CKD HIF-PHI expect the the is the fact growth EU-X EU countries only reimbursed both that We of patients. non-dialysis to in and dialysis of is the this in anemia continue indicated treatment roxadustat and given all

over to Importantly, HIF the next EU, it leadership exclusivity roxadustat XXXX into its decade and the plus. continue market has in growth positioning

AstraZeneca of the exception to U.S. with potential roxadustat associated with Earlier XX. the rights financials. year, we development returned remains us China China all will over anemia South to allows in collaboration Juan myelodysplastic agreement with company's call such to that Korea. Slide U.S. roxadustat opportunities to FibroGen's now roxadustat Moving turn as for roxadustat to the announced in firmly and to syndromes. I pursue ROW AZ place. in discuss with Regaining in partners rights lower-risk indications the Juan? in the the

Juan Graham

Thane. you, Thank

while affected on valuable would for objective difficult learnings dedication I the with future thank diseases new affecting in operating moments for Firstly, on FibroGen XXXX, like remarks financial courageously of to performance developing will of cancer. I achieved, over organization development details hard for team and results therapies take will I China up and their to our quarter quarter. the our to our wrap patients subsequently entire finally, to was focus the our focused has The the with for providing years. humanity. therapies information not provide revenue And expense for provide the very outlook. options with summary the work expect a a in few my second business pancreatic I And cash

versus For of in year-over-year. compared XXXX. in CKD. of the second $XX the representing quarter XXXX, in revenue expectations compared revenue China $XX.X of of XXXX, supporting million. second continues an increase we million deferred QX development this in One, drivers year-over-year. The revenue sales last of XXXX, of million to release were: to XXX% million period We In China net compared in a during $X.X recorded roxadustat in increase Roxadustat of strong revenue million for our with XXXX, recorded XX% the of for million results, future volume growth revenue to performance total increase $X.X for patients to $XX.X leading year; $XX.X and quarter to product an second assumptions two, million of $XX.X XX% was deliver quarter the same changes

be second million quarter been in million the territories continuously to revenue has QX quarter, year. In we the $X.X last $XX.X drug the product we quarterly the of performance World during development remainder termination recorded As $X.X of The XXXX. Rest of mentioned than of of Astellas XXXX, to AstraZeneca the agreement, for of million below expect weaker U.S. roxadustat compared revenue after expected. the

to forecasted of to XXXX, transfer an we impact increase growth or China. in territories. I the JDE a this in joint from sales the quarter compared FibroGen, million sales in portion was performance FibroGen, value our enabled JDE, maintain XXXX, performance FibroGen distributor associated Astellas sales to the of lower $XX.X cash inflows quarter future share by million roxadustat and has From projected entity related to compared net quarter to in owned from us We AstraZeneca XX% financial Total This XX% to future XX% $XX.X the second will to achieve category increase was the to distribution total from royalties and on China. year-over-year. Net $XX.X net sales this of and best the year-over-year. will of of anticipate in of million move is roxadustat of quarter received continue further brand of in which an cash net $XX provide direct price the now to the roxadustat sales China, FibroGen's detail second million in the China. reflection assess net [indiscernible] and from FibroGen's

released we million to earlier, this from deferred for in forward-looking changes expectations quarter, stated During China. I as roxadustat primarily also due in $XX revenue

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

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

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

and XX% expenses million of for Now in quarter year-over-year. compared in the $XXX.X the moving trial million Fortis million quarter onetime a decrease $XX.X drive reflecting XX% were R&D million directed $XX.X to income development million FG-XXXX, million expenses our XXXX, second acquisition or million down directed range X% $XX.X infrastructure, quarter continuous the XXXX R&D second quarter statement. on to spend, towards Operating of of came $XX.X second to of million, to of XX% our the expenses XXXX, below of clinical for our year-over-year, for XX% to expenses, expenses. Of second for pipeline assets of in immuno-oncology the our million roxadustat of pamrevlumab, the $XX remaining of showcased costs the disciplined results. and approximately our XXXX quarter reductions $XX.X XX% with or a spend guidance was quarter primarily second decrease Operating $XX.X related were compared activities. R&D support in $XX to a pamrevlumab reflection

We our SG&A second in were expenses infrastructure. XXXX in the decline of company's resulting efforts, quarter reduction the $X.X of expect in the the immuno-oncology $XX.X cost compared and the to to million driven million XXXX, or decrease pamrevlumab quarter $XX.X R&D million year-over-year, for significantly second of expenses XX% year. a half second of by primarily a leaner SG&A

of million Finally, million for $X.X cost of the goods compared $X.X quarter was sold second XXXX. for the second XXXX quarter to of

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

winding are second recent we related the during the obligations down pamrevlumab outcome, and our to of any negative assets immuno-oncology XXXX. pamrevlumab remaining Given half

of reduction announced to third and end third in we at our the U.S. quarter, the of backdrop restructuring cost and We this a goods workforce expenses, including total fourth excluding have expect in or our approximately also million sold, charges $XX operating XX%. With higher the estimated end any between at quarter lower fourth and to be million $XX quarter estimated fourth this the quarter per quarter, with the to range. third of be the and be in

towards shifting Now cash.

million moments spend in to a our and cash It equivalents, in $XXX.X reported cash few important we cash, accounts XX, balance. the June of As is changes receivable. highlighting

burn quarter to second the Astellas true-up in million. Our of a $XX.X reflects payment cash

their future reduced orders expect moving a We slower-than-anticipated payments territories. forward significantly their be in has reflect to launch to roxadustat any as future lower Astellas true-up of

had Additionally, agreement. of U.S. termination payment we of due a also onetime inventory our the to of Rest in to settlement AstraZeneca quarter $XX.X World the million

quarter. second burn net in Excluding these cash cash our outflows, was operating the $XX.X million

second reduction our the expect to second what continue maximization cash our will direction. to net in focus be half initiatives strategic We believe lower we to towards We the cost pursue operating experienced us burn than enable quarter. cash XXXX that quarterly and

and Finally, fund accounts as will now, call the turn XXXX. our Thane. back to receivable you. And equivalents, I communicated, cash over and plans expect we have our Thank we continually cash, into operating to

Thane Wettig

an excited about Thank continues the year with decision value Astellas, to potential of you, markets. In perform indication prospects second the roxadustat very we and and China in provide the and stakeholders. remain Europe, our expect commercialization this they Juan. approval sNDA of where half to for company's well our of closing, we continues Roxadustat chemotherapy-induced Japan, other in anemia partner, in the the

we recently totality reported I compelling castration-resistant the that AstraZeneca, given the we in of PETXX, FG-XXXX I FG-XXXX the are in from and for we'll and lower-risk U.S. of anemia patients monotherapy MDS. territories Additionally, manuscript. to Phase roxadustat actively exploring regards upcoming metastatic in regain prostate top-line publish study With ROW with potential cancer data we from in opportunities for partnering rights Phase an data

anticipate XXXX. of FG-XXXX study in portion we of optimization dose first and study II the the initiation in XXXX from the We Ib in enzalutamide at combination with quarter top-line presented the have escalation Annual mCRPC the Meeting Phase compelling preliminary Phase of first half in June. We anticipate FG-XXXX combination ASCO also of XXXX data in our results monotherapy dose II the from in top-line mCRPC study of of Phase

As earlier potential the continued partnership the X immuno-oncology will capital. development aim we we access with of FG-XXXX non-dilutive their our and early-stage FG-XXXX assets, FibroGen ensuring with in and providing stated to for discussions initiate call,

XXXX. In work over and FibroGen and perseverance last a expect X have like late-stage to turn trials ADC we their have into a of strategic the current the believe to our sheet sheet. I outcomes as our we fund valuation continued our necessary and summary, all difficult, like against PET upon few Q&A. Finally, cancer. would position over of future reflective balance Juan operator these thank companion updated We believe strong we said, roxadustat based first-in-class that employees as some to the current the very call of the pancreatic is hard to to now made FibroGen agent decisions we and strong operations our execute but attain and position, our to successfully decisions streams, of would for months. I strive in best for cash priorities imaging pamrevlumab more balance revenue

Operator

The from first comes with Blair. Instructions] Andy Shay William [ ] [Operator question

Dalton Greenwood

Andy This Greenwood Shay. is on Dalton for

Given how the on have asset's do singular focus have roxadustat in as its on Could business comment robust you China plans a In maximize FG-XXXX liquidity the of shareholders? the just on the development value strength parallel, now, you roxadustat's to In revenue? words, of based on you, clinical for any a profile. very entity, cash derived cash the you other do generated U.S. from access China? accelerating

Thane Wettig

for is to Thane. ask if the on Juan as this our Chris Thanks the then needed. on cash questions. touch touch XXXX Juan your I'll question I'll And obviously, about here and is Dalton, to of Hello, from the complement question Chung China liquidity well operations.

a that been pamrevlumab just catalyst acquired -- it from because XXXX, extent it Fortis we we we asset from it the We the didn't in us priority highlight last to since of proximity highlighted always that of of As the time. pamrevlumab for has just year. to for May it relates

is to our will it with business has because of will be so we that's and an the and speed. try continue the quality that been game prosecute to speed name asset And in

able Phase on initiation be interaction to an we the plan important in Phase up would this the that FDA time. with coming after and inform which the program have trial II help point quarter, of II to expect design of the will We the then

yes, So can. we as prosecuting it as are quickly we

Juan Graham

regards the in we cash in the cash second debt cash China, China your last course year over so, have operations. with this from facility to we China, Juan. had up And -- Yes. generation the been of as With a or question China to on registered that is our based set regards with repatriating

China. we that will also to cash from front. to continue We facilities, continue other on beyond avenues And that, are repatriate exploring other

some I continuously and of the that are, money back to we're the U.S. bring those bring elements So think, evaluating to

Operator

Gerberry America. Jason with question comes next Bank The from of

Dina Ramadane

Dina us. on had questions just is Gerberry. for Jason Ramadane I This X from

like then to of could How to partner early beforehand? begin preclinical data? more first look just, generate of data you'd could soon follow-up. of one that that an the X assume timeline to on some fair how to your The expected guess, it have candidates? Is you look I discussions? back those I you sort of is preclinical be of I kind a And Phase would have Or on

Thane Wettig

of the a data had fact will extensive the set set. IND it's parties very package for we that because Clearly, antibody, that potential data data had recently anti-galectin-X So -- we a would to interested have preclinical the showcase the be cleared. to

and able we to believe what to the mean make there them. And forward to path potential be potential of the there's could so determination information for partners sufficient the value

expected CCRX, that previously IND sometime For time in file XXXX we the an we frame. stated to had

has done, said we've antibodies, work done that that of good in And optimization affinity best CCRXs, of specificity, them, quite and team that our potency SAR we've like can the other antibody. a feel our CCRX lot as as as compare we about to as comments, comparisons we very maturation, we compare on nature other work opening so the done things antibody feel and and I've the on very,

so couple that's is to in different spin-off. Oncology, one there's Gallop targets. that just particular PureTech and have access antibody a really only well. would play to from There's of partner that would And reiterate, And dynamics a anti-GalX a clinic in X potential which with maybe information be other these as the

seems space about a it you're I'm an antibody. And now, as while incredibly from well. emerging excitement with really hot position, we're aren't category, GalX sure we with of there's as activity. And think aware, perspective the competitive position in we right so it a in favorable then as CCRX like lot there's And the timing our mechanism a is a good

both good to feel those partner we ability we're of immediately. about to start the going So these and activities assets

Dina Ramadane

follow-up here. me more one then for And

would top-line of number what's of and could Just patients duration maybe confirm the -- can prior to what like durability data cut. of that if data And patients PFS of from -- benefit enzalutamide? expect we FG-XXXX's we with see? at set the terms the then consider sort see Just the to please on the update in saw of nature combo that could trial that expect the is you that of response bar clinically wondering of meaningful a follow-up we you'd you

Thane Wettig

question, you good one? Deyaa, Dina. I'll that turn answer to one really to a that that's Deyaa do follow-up to over if want it No, and needed. then I'll take

Deyaa Adib

you, for Thank thank Thane, Sure. you, this and question. Dina,

So have as dose have at and II started study the Phase already UCSF, has the I ASCO, dose. they Phase component escalation, you at already expansion the the completed II realizing seen combination Phase recommended after

that So -- This you of data PET encouraging is very, because post having X ARSIs. those from that patients area were of XX said have abiraterone this the have the seen acetate. of also failed is the They very population that, majority fact dose needs. escalation they medical don't prior constitute

months So is for bar have radiographic X after failed those is to for patients meaning very this setting, PFS, XX.X rPFS. ARSIs, months X this have patients exciting. The prior around

only as the months. is X has exceeded already can which bar, see, you combo So the current

the case, This somewhere [Technical to strictly line the Difficulty] treatment potentially the moving rPFS, and setting, more bar going completed the to line, prior of once with have are abiraterone higher in months. first one the up see second acetate between XX current in in much the XX terms only comparison will patients we setting. line first, In ARSI, is who and meaning be enzalutamide patients this

the and will be results in So next combination, year, a we of from able XX I the this -- first total mean is QX of top-line are or publish landscape the having study. half to we patients the the that current of hoping in

meaningful line, line data robust a first to setting. clinical be give will signal line us or activity of in it set a So either second

Thane Wettig

that would being well. add also the expansion that part of as Thanks, data patients cohort additional Deyaa. That will was excellent. Dina, are PET now one these enrolled imaging is thing that as have I

begin So potential as Small it mature some addition additional CDXX also point We'll be to well. that will data us. and and spoke Deyaa information but a in expression that's for characterize important rPFS to. more an able see be to response numbers, to

Operator

Sachs. Next from question Choi comes with Goldman Paul

Kyuwon Choi

impact? this if pricing was potential is there about by guidance. your driven [ be your continued the July, are in you maybe in guidance a may maybe ] generic then comment think CIA the just starting are indication? you first had And And this a of marketplace on updated of pricing -- from approved. you volume My how headwind versus yet in on second to and the potential roxadustat -- my the I a volume on driven Curious is, a raise question question growth believe from of it I your approval offsetting thoughts what quarter. CKD can indication volume see XX% by on much

impact launch So the any updated on thoughts would the be pricing competitive appreciated. from

Thane Wettig

start Yes. Thanks, Paul. Chris to I'm It's go it and to then Thane. I'll ahead going as and well. over turn

roxadustat pre-ordering like anything of underlying There's In CKD team performance the in of XXX% anemia raise indication the by continued in in strong to the guidance, or terms of approval due the by that anticipation indication no China a itself. of that. performance in it's the CIA and of

inherent strong just all demand. it's So underlying

said a X% revenue XX% have entrants, to down XX% year. the at generics from there are been X approved. our growth, renewal growth was This of to as the that in volume In last of the opening there we part XX% as generic reduction terms VBP end remarks, price walk of

not when There And be XX% expected upon happens a price X% so VBP, headwind. included price roxadustat was the really a government dependent calls And will and the pricing then there's VBP. for if what for in be headwind. to

Chris her knowledge ask me given intimate there. of color, some additional Let environment the to add

Chris Chung

Thane. you, Thank Yes.

launch the have the we not seen of the Paul, generic So on market.

are vote. adoption. to a at to you are no to market sense With difficult pricing, we in respect very this change there it's So to pricing until of time, entry point subject in to give generic plans response

Kyuwon Choi

XXXX on just as on data. could of on think probability that, planning next I the road, look the the Or to year. if is population? pipeline from please, terms in one follow-up about you And on dose combination? particular you be the positive might as question, focus additionally the the combination squeeze But work increasing of optimization you'll PET in any obviously, like population starting think success PET you that will focused down positive the guess primary benefiting your primarily beyond there be I

Thane Wettig

Yes.

off it turn Deyaa, to start to I'm you. I'll So and going then over

Deyaa Adib

Sure.

Thane Wettig

the correlation to could CDXX is exploring is with a enrich going really, III is, that to between the Phase the expression drug in then if PET, So be portion response there to trial. to II, understand Phase Paul, the we're what of us in allow the trying

We're Phase as it correlation a selection any if II. using sort not if of the it there part or of criteria diagnostic we're and as understand using so a is And patient to Phase we'll go your the there trial. Deyaa enable that that to if Paul, addressed then, to of and and the portion question. see III ahead really will add is, would that then enrich us

Deyaa Adib

Yes, Paul.

conducted I of the for with you an in our remember was thank enzalutamide question. But top [indiscernible] Fortis, in that Phase just derived unselected study So on I addition that, population. by conducted to confirm what been completely Thane that from has data all the combination mentioned. current has

true. very So that is

be be clinical if will by another patients they all-comers data derive them opportunity to to and the strong robustness KOLs, opportunity the us continue our when focus tell signal also for in of primary that show rPFS. But Our benefit there to could to enhance with talk PETXX. we pre-selecting

all-comers as is PETXX will going in to long opportunity the So pre-selection. very not strong data. this to see But something we that but primary continue will be as like another abandon, it we is focus be

Thane Wettig

more still minutes. we have a Guys, few

additional So Paul, have if any Dalton, Dina, you questions?

Operator

to in appear the queue. There questions be no further

session. So like closing this Wettig back turn question-and-answer the over will for would any I conclude remarks. Thane to conference our to

Thane Wettig

call No, Enjoy the appreciate of interest thank guys. you. today's in day. your FibroGen. participation the rest your really We and in Thanks,

Deyaa Adib

Thank you.

Operator

now today's presentation. conference Thank has you attending The for concluded.

disconnect. now may You

FibroGen (FGEN) 6 Aug 242024 Q2 Earnings call transcript