FibroGen (FGEN) 7 Aug 232023 Q2 Earnings call transcript

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

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

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

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

results Following Such like the design, and to open and may not development and regulatory are statements Astellas, our forward-looking our matters. results, on conduct call would that our you regulatory certain risks other questions. business results include business remarks and of include, made commercial results initiation, with guidance, but and I we strategies the trials, our prepared related to to, potential and financial AstraZeneca remind remarks, limited research today's FibroGen. to our collaborations of about will operations, enrollment, call your clinical statements activities,

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

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

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

Thank everyone. and good Dave, afternoon, you,

important remaining have remain for dystrophy from recently my as colleagues. roxadustat I our pamrevlumab faced, and pipeline. me enthusiastatic we First, and setback would our exciting with is business like despite that our my CEO. in muscular dedication for our FibroGen’s tenure trials pancreatic during thank highlight Thank cancer, take thriving to commitments opportunities near-term the readouts moment you It to given FibroGen and I a China your to early-stage about duchenne

CEO. Furthermore, leadership have cash us will board. a to talented team through well be the allows our our strong evolution team as see pipeline, that we delighted of I that position and Thane of Interim of leading am as our the quality across proud the as FibroGen

during and him Thaane worked over period about a years I in Lily as business. growth for years Lily at he diabetes with during have known several where at Diabetes closely blockbuster years for have Chief medicines XX launched Chief as unprecedented Officer, of Marketing XX Officer capacity for FibroGen Lily’s his of commercial his three and

our During effectively. instincts keen business and excellent ability working organizations together, times I lead judgments have his to appreciated

So, delay, without call Mr. I’d Wettig. like to pass the to Thane further

the three Enrique, done all You, that FibroGen have Thank past you years. for over for

our early-stage my built future. here and outstanding bright at and you the FibroGen of with FibroGen created years pipeline benefit and I at past part the working will and better You to a the Lily the performance-oriented have I've an built personally, team, of culture toward lead do XX leadership had for best

and front personally this us call. for of highlight to opportunities bring value we will excited shareholders, many the I'm in create of patients to about value in which we have

into discussed call. call, as perspective earnings John roxadustat Good second will well our early-stage quarter then the guide and today's in will not provide afternoon, pipeline, Officer strategic review four our of our providing as this and pamrevlumab that Hunter, a On stakeholders yet I type focus our will on the to oncology our exciting company we Scientific everyone, update assets. on an XXXX Dr. Chief forum. pillars have that welcome future, the

CFO will after FibroGen pillars significant will Starting strategic Graham, financials, value that four we Juan today. key has Lastly, questions. believe review Slide which call the our on we X, for open your offers the

readouts First quarter is pamrevlumab and with year. of first three half upcoming the starting late-stage this next through

substantial in which in indication commercial will more in Each I the slides diseases significant walk opportunity represents through coming detail a need. of unmet

growing partnerships in roxadustat. economics AstraZeneca net world approved and significant with countries Astellas generates material with through and FibroGen Roxadustat XX revenue is provides is the our around Second Pharma. over and

early-stage the conjugate We a drug first-in-class completed recently of in-license FibroGen-XXXX also through development biomarker ADC the now as castration-resistant our cancer. of pipeline. This an is oncology opportunity metastatic diagnostic. includes associated Third license for treatment or known antibody a potent PET the of prostate XXX, biomarker-driven

In strong addition activities are on we also to the undertaking two XXXX. clinical position. is innovative our cash activities molecules with commencing Fourth intention oncology FibroGen-XXXX, IND-enabling in of

into Post our to a bridge extends value inflection cost achieve across portfolio. ZEPHYRUS-X the results, our provides cash a our runway XXXX, that which have points we implemented reduction company-wide company numerous plan

necessary We financial position to and the discipline. will on have taken continue we financial improve our strong steps focus to

of a talented In balance we significant have When to shareholder quality believe a that combine our assets, early-stage believe mix of future. such the and FibroGen, and strong market are summary, our our there have drive colleagues compelling we we of sheet, value you creation into foundation commercial, of and strong assets. few our today, biotechnology companies that late-stage cap the

an patients, studied and of in been been pamrevlumab treatment monoclonal clinical pancreatic X, or for adverse safety dosed and to favorable patients dystrophy to locally development metastatic Slide in event a pancreatic cancer. or up who a X,XXX Moving seven years. the for including profile, has human unresectable duchenne have antibody and muscular DMD, advanced ambulatory LAPC anti-CTG, demonstrated in is over cancer has Pamrevlumab

placebo-controlled treatment corticosteroids. patients provide our DMD with top-line as On a results, non-ambulatory June, review milestones. study, trial on Phase of recap for as a our X background Slide LELANTOS-X X, the data to In announced we recently with I like well would upcoming pamrevlumab pamrevlumab reported from of

did like patients, the endpoint primary dedication not these the performance study caregivers week-XX trial participating baseline. Limb contribute and Upper studies, of clinical X.X thank their meet at the score disease. towards of to understanding to of the investigators FibroGen important this in for compared to devastating The which would

from change FVC study and in ml. a arm, ml line difference placebo-corrected correlating we compared In X.XX, placebo baseline The the decline with meet FVC week, to to in ml the XXX top a XXX June, XX the enforced the arm placebo pamrevlumab baseline, P-value in in our with from was study at not IPF. of mean data to of XX of did ZEPHYRUS-X to announced capacity compared vital primary treatment endpoint pamrevlumab week-XX, or from

or The equal of endpoint was which of XX% secondary predicted FVC greater met composite progression is time not also to with of death hazard or decline to a ratio a X.XX. disease percent of than

IPF like in results our Based We second Phase patients X thank we both for IPF clinical would trial. trials. of investigators discontinued ZEPHYRUS-X, in the and to trial dedication these participation clinical on these their

anticipate ahead, we upcoming trials. three results pamrevlumab from Looking

data later X top-line expect We from DMD LeLantos and this ambulatory quarter.

half in combination Pancreatic results settings and from promise quarter for trial cancer expect precision LAPIS patients of in standard-of-care with XXXX we expect in We second-line in XXXX. of evaluating the in Action adaptive both pancreatic Cancer Network's with pamrevlumab the platform, LAPC from the first and first metastatic first-line results

in a normal mutation a fatal each dystrophin, weakness, in dystrophy. is year. The each with genetic I more detail, and into affects function. by muscle of DMD thousand disease will muscle of is leading that necessary absence DMD duchenne caused newborn and disease fibrosis in debilitating for opportunities starting these now for approximately dystrophin children of with every muscle muscular boys. diagnosed About defect protein loss, rare one XX,XXX five The globally the absence go neuromuscular are to inflammation. results a

with medical weakness and of before DMD are Patients muscle. muscle problems respiratory to progressive to their the may cardiac and wheelchair-bound related serious lead often XX age

Slide quarter. North primary X, expect this we later patients that and XX is On ambulatory to endpoint function the ambulatory a The results major DMD Star top-line ambulatory LeLantos assessment, of X enrolled XX of note we years age. of X

nature a therapy ultimately provide Given these for filing needed the are the of LeLantos we X X and Phase of the progression regulatory hopeful that a desperately patients. study and to lead DMD devastating relentless disease can

X, despite have the improvement billion of DMD. the in perspective XXXX, small pamrevlumab or opportunity exceeded Exon-Skipping a demonstrate symptoms in currently patients meaningful that therapies of and clinical provide In a Slide for the $X.X commercial DMD fact disease approved proportion we branded yet to only On DMD revenue progression. a target of therapies

attenuate There DMD pathological for muscle is therapies disease to progression targeting clear a that function. improve downstream need the changes can by

opportunity commercial help these that the for a anti treatment maybe represents fibrotic hopeful their mechanism a are of families and significant and patients can We pamrevlumab. pamrevlumab that

the on in Moving patients annual Slide combined approximately major overall one XX. with X-year oncology across pancreatic and million of largest regions cancer needs XX%. a cancer rate to represents of an unmet incidence Pancreatic an survival the on disease-free nearly half of

Slide we tumors. patients effects a Based role CTG pancreas like to clinical Anti cancer. progression why provide pamrevlumab cancer. for both the both anti-tumor use the diagnosed providing an and direct data, tumor CTGF can and an pancreatic plays in antibody shown would up On believe to surrounding in have pancreatic we strong and would Mouse overview growth stroma, have as a studies XX, important rationale provide like brief on benefits of to pamrevlumab the with that on LAPC metastatic effects preclinical

cancer potential and are majority XX% diagnosed Slide in pancreatic to with a pamrevlumab disease. being LAPC devastating represent opportunity patients across late-stage These treat metastatic this to Moving both XX, giving a patients today pamrevlumab of vast conducted almost of all patients trials patients.

we locally and placebo-controlled the quarter provide expect pamrevlumab study this standard-of-care first trial The primary double-blind, to XXXX. of in in combination the XXX with X, we Phase top-line in a data endpoint patients pancreatic survival of is unresectable overall placebo LAPIS from XX, Slide with On overview chemotherapy. comparing trial, advanced cancer, an

the study endpoints. represents definitive study line survival, On pamrevlumab combination offered pancreatic design. The first This slide registration of is either overview Promise to with registration or overall FDA-approved primary cancer X as an is X, XX a trial. Phase treatment. The therapy endpoint is Action Network's a second an Precision which a patients is

offered in PanCan’s Innovative Precision the arm treatment first-line be treatment a trial. to Promise was Pamrevlumab as experimental first

of We from this first expect top-line study in data half the XXXX.

overall a a pamrevlumab in of in immuno pamrevlumab subset treatment the limited creates Slide in pancreatic or for oncology over decades This multibillion-dollar to in metastatic for opportunity small can improvement opportunity cancer. demonstrate commercial XX, metastatic disease patients. commercial review therapies been two either survival metastatic unresectable benefit it and advances we have the patients. significant both There a potential advanced last providing locally if On with

upcoming our on risk to announced review recently our announced myelodysplastic would XX. roxadustat from milestones. onto roxadustat treatment transfusion-dependent X May, of of Slide we I In results, data phase patients recap with for anemia like syndrome. Matterhorn Moving clinical well of as lower top-line study a roxadustat provide in as

chemotherapy its primary from study treatment not to roxadustat weeks the positive anemia of average treatment non-inferiority, to efficacy This erythropoietin endpoints. for for our change Roxadustat endpoint primary study recombinant level May, patients XX. did Also data concurrent the meet of clinical compared level demonstrated Phase China. in during the X in line through we non-myeloid top baseline, in on of in nine hemoglobin malignancies announced alpha receiving from

We could to application China. patients net with sales potential $XXX XXXX. new Authority expect and that in opportunity to roxadustat chemotherapy-induced roxadustat supplemental anemia over drug the pathway million pleased in filed annual in a indication China meaningful we for believe incremental approval in achieving providing revenue announce net a am a mid represent have Health this I with

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

second Second the to quarter in AstraZeneca in by net FibroGen an total million roxadustat FibroGen quarter by XXXX, $XX,X China of was $XX.X million, XX%. increase the jointly of and entity owned sales and distribution compared

was growth basis. quarter revenue GAAP volume of net driven an roxadustat for This second US portion in on XX%. in million by increase a product the FibroGen’s China of over $XX.X was

XXXX. in the Slide remains the roxadustat in in rising quarter share of to China, I touch Europe. in briefly second roxadustat to would XX% leader like to Moving category brand XX,

In roxadustat performance launch had in growth. addition outstanding to quarter-over-quarter China, the of roxadustat Europe continued is in accelerating the robust showing

exclusivity continue the non-dialysis of both for EU to in accelerate HIF-PHI the in the and is CKD dialysis competitive for position of to combined for of throughout XXXX, patients. growth roxadustat. strong this roxadustat to GSK’s continue indicated recent decision withdraw expect only We Daprodustat, MAA this its given treatment market beyond the growth the decade. to anemia well positioned with with Roxadustat And roxadustat is

May terms that On will Xth early-stage few Moving Hunter was and on upfront announced Slide oncology Fortis cash we Therapeutics opportunity to FibroGen-XXXX, the that more Under agreement, license potential detail into the describe consideration. for first-in-class of our CSO our entered in exclusive a XX an next no John pipeline. FibroGen slides. there the with

conduct FibroGen and manufacturing FibroGen-XXXX fund PET-XX. and future will development biomarker of and research, associated an

option metastatic acquire the during second the four-year castrateion-resistant in prostate MCRPC the Fortis period additional for with have to or XXXX CDXX trial in X $XX million. of the Phase initiation other expressing half anticipate We We cancers. evaluation trials targeting the a potential for of cancer

I will early-stage off pipeline. to now call our hand Juan cover the to

Thank you, Thane.

a validated to anti anti-mitotic antibody in-licensed an is has cancers levels in clinical found other ADC MMAE, metastatic recently is solid by targeted Slide our a for commercially of episode tumors. linked comprised and XX majority the in subset agent antibody of colorectal CDXX high The clinically to an and of is FibroGen-XXXX tumors Moving ADC levels expressed conjugate program which also at prostate high castrate-resistant, and at drug a CDXX, warhead. YSX FibroGen-XXXX

a response Moving in XX, has we're data to ongoing based in evaluable rate trial four and where from of X XX cancer, demonstrated prostate XX% Slide patients response prostate are resist was myeloma at PSA observed. of had castration-resistant monotherapy metastatic out the multiple cancer. clinical on interim here at XX Shown FibroGen-XXXX criteria Phase efficacy partial

being with pretreated The were most study therapeutics in was therapies. common ADC this a prior X other The patients profile with adverse MMAE neutropenia five of the event. for median FibroGen-XXXX based Phase consistent safety heavily with

data the reported upon will Additional trial be completion. from study

show FibroGen-XXXX. ongoing to planned we XX, and trials Moving Slide clinical for

Phase to a X UCSF. the is study also addition and previous on combination with enzalutamide In dose being expansion is the run escalation that slide, referenced study currently there at

them in based enzalutamide data is responsive CDXX with of the combination to The rationale half tumor more of treatment, demonstrating this preclinical cells trial therefore FibroGen-XXXX. for Initial expected following XXXX. on in upregulation making this from treatment is potentially second data

UCSF. assay There is PET high a FibroGen-XXXX. biomarker program zirconium for to of to CDXX also expression study benefit Pet Agent goal targeting a develop the from YSX, treatment coupled Imaging screening The to XX, most with at select antibody CDXX is to likely run currently the in trial progress is who comprised are the being with patients

the run in a to of the potential the will efficacy by of study be be but correlation will which FibroGen-XXXX Patients a Phase part end the stratified be stratify of between Phase will PET the PET assessed with the patients will X pivotal This in a biomarker study not with be trial. XX. to the following X scan up PET at positivity FibroGen to patients study PET XXX enrolled and start use at biomarker

cancer trial initiation We X in anticipate the in the the half metastatic prostate second castration-resistant of XXXX. of Phase

oncology would our Moving to preclinical like programs. on some slide I XX, time spend to

in has is tumor GALX that solid is suppression in tumor immune a many been mediated microenvironment program an been immune resistance mechanisms immunosuppressive developed discuss that Celli antibodies and reverse effector including GALX first mediated overexpressed Galectin-X an X suppressed The prevention and to of implicated of has indications tumors. FG-XXXX in molecule reverse antibody like soluble pre-clinically I'd multiple T anti-galectin-X shown the maintaining mitosis is immune to to TIM dimerization. FibroGen-XXXX GALX or

towards at program preclinical a first data later IND are XXXX cancer We this for this will a conference year and present filing. working immunotherapy quarter

is limited defeat antibody XX is Tregs cells Tregs, tumor anti in T receptor that program, regulatory selectively microenvironment. expression with our Slide disrupt peripheral designed T tumor on regulatory known microenvironment the as to the without is outside CCRX CCRX to expressed tumor affecting and cells. highly an Moving very FG-XXXX in CCRX of a infiltrating

for optimized development. highly the developed antibodies its our versions competitive Given of previously CCRX, clinical landscape targeting we during have FG-XXXX

While we model dosing. on clinical as acceptable we candidate potency a FG-XXXX preclinical decided efficacy have shown as has our been competitive based colorectal and relative projected in FG-XXXX have marked to it and of advantage monotherapy advance to clinical feel cancer,

tumors. in Given to in is will financials. Juan? the we the is to company's of highly call over broad now discuss potential solid targeting specific having Tregs the FG-XXXX I therapeutic Juan microenvironment tumor turn

straight financial Good quarter’s John. everyone. afternoon, the jump results. you, into Thank I will

For of period $XX.X compared for our same XXXX, million provide increase $XX.X quarter the a will XX% was to year-over-year. million second revenue on now in of the robust detail total XXXX, revenue. I further

second China, As net of of sales $XX.X roxadustat QX in the we revenue million of compared for X% in year-over-year. recorded XXXX, of $XX.X representing million XXXX, an increase product quarter to

or development drug of the million product sold $X.X product also drug During We ingredient co-development of second second during during Comparatively, recorded pharmaceutical drug in million ball revenue roxadustat XXXX. million recorded quarter we as our the the $X.X efforts associated to for active with quarter, was roxadustat revenue revenue $XX.X of partners product to for compared XXXX. $X.X with million Astellas. quarter

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

$X recorded we biosynthetic from associated a Eluminex. license Finally, million of cornea with milestone program revenue payment with our

and context strong business performance the our performance. will financials China, I provide further around Given in on

quarter launch achieving substantial previously performance categories quarter the XX% FibroGen market a owned since jointly China, of his ISA franchise compared was $XX.X our of by roxadustat highest by the sales combined. EVRENZO and in increase strong of distribution XXXX, net of to highlighting the XX% joint the year-over-year or continued of Thane, share As in million and $XX.X AstraZeneca entity the mentioned from JDE million total this second

to for in sales the of percent JDE of from net portion the transfers compared China, to received the Net year-over-year. quarter From million roxadustat China. price in increase by best an second second FibroGen’s quarter is XX% roxadustat $XX.X the price million XXXX, reflection of the total cash of net sales $XX.X FibroGen’s transfer was in

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

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

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

the year-over-year were charge million The driven our in-process XXXX. of million Now $XX.X XXXX second moving for non-cash of million by million, Fortis acquisition of down resulting primarily per GAAP. the expenses of is variance second and asset $XX.X for $XXX compared acquired a operating quarter Therapeutics recent the us quarter one-time of statement, income costs to from R&D of the as $XXX.X

Excluding essentially to one-time our expenses million were would of XXXX. be non-cash R&D in charge, $XX year-over-year. million, second flat $XX.X second such XXXX of the operating compared quarter expenses for quarter the

a include just R&D acquired I Therapeutics. of expenses million As quarter non-cash of for resulting the from R&D charge of $XX.X one-time Fortis mentioned, recent in-process the acquisitions expenses asset

XX.X Excluding the such essentially again, flat quarter, million one-time charge, year-over-year. expenses for were R&D

of and development was pamrevlumab remaining XX% Of in that directed States CMC and dedicated development our mentioned, and the support China. early-stage XX% to roxadustat million United just allocated the approximately pipeline expenses towards the $XX.X R&D I activities activities, to XX%

of the trial coming the pamrevlumab in IPF significant a outcome Given reduction subsequent in will see termination quarters. R&D the related ZEPHYRUS-X, impact to expenses we the of on ZEPHYRUS-Xwith

XXXX of XXXX flat million were to compared second year-over-year. quarter second $XX.X remaining the SG&A the million, expenses of relatively quarter $XX.X for in

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

expenses. the announced asset basic On approximately impact restructuring a $XX.X to we of plan non-cash XX, of the Fortis per broader July charge effort, of loss part abovementioned million acquisition $X.XX cost share. and diluted as lower to related of net The our represents one-time operating XXXX, reduction a

be $XX the US XX% approximately $XX an in of the of be million incurred of related The majority million. The restructuring will XXXX. which to employees. quarter of that non-recurring to reduction in the expected plan to workforce We FibroGen’s estimate or third includes range payments XXX

trials are In we to infrastructure associated expenses general of reductions headcount-related reduction expecting addition reductions, announced in in our termination also a other and with IPF recently costs.

our the XX, Slide charges average expected million $XXX the were savings GAAP expenses mentioned. future half with reductions our lay approximately On I I In quarter. operating per one-time associated GAAP of and out first just XXXX,

GAAP million charges, million $XX million and expenses we expenses approximately quarter. $XXX to in $XXX million savings anticipate one-time $XX annualized Excluding expected of per or total, to

We XX% first achieve run our savings in third to achieve these to of in the the expected quarter XXXX quarterly up savings of of to of expected XX% savings XXXX. the in quarter XX% expect XXXX, quarterly rate and quarterly of fourth quarter

million June equivalents in Now shifting of reported cash cash, accounts towards cash, as we XXth, investments receivable. $XXX.X and

additional cash Morgan of Our our quarter. ATM facility includes our Tactical through raised million $XX.X of debt Stanley proceeds net with use the and balance Value during facility

sufficient we the With to investments operating of equivalents, XXXX. approach, into disciplined allocation our plans expenses reduction a capital and be our and cash, fund receivable accounts maintaining operating expect to cash

Thank you. call the And like Thane. we'd turn to over to back now

of DMD committed X, Pancreatic XXXX; late-stage LeLantos top In in Action Cancer studies, significant we first closing, with Promise we pamrevlumab the potential this XXXX. the Network first-in-class noted, from phase unmet Pan ambulatory Juan. Phase medicine cancer to data and metastatic phase in three in line and the quarter; following three X, advancing in as Can’s X, indications LAPC first quarter LAPIS need or expect in a as half trial medical X, Thanks, Precision pancreatic X of are

second for XXXX. for in cancer our of XXXX, anti-GALX and half initiation the an the antibody Europe of and of the FG-XXXX filed of to filing anti-CCRX of in for XXXX where of we pipeline, the castration-resistant roxadustat filing anticipate FG-XXXX antibody for IND CIA early-stage metastatic trial FG-XXXX, second In the sNDA our Astellas in the continues Japan. continues our a we recently in the phase half first perform our IND indication prostate and an quarter Roxadustat well very commercialization partner in with X China,

our We thank operations position would few of I balance to strengthen have employees work over their the our fund and further last transactions the months. XXXX. financing expect continued sheet of and hard completed current for to all into incremental FibroGen cash like perseverance to

now the to over turn Q&A. I to back the would operator like call for

Thank you. [Operator Instructions]

the proceed Jefferies. Our question. of with Michael Please line with your Yee from first question comes

This [Indiscernible] for on Hi. Thanks taking is the for line Yee. Michael question. my

think China? two may? I roxadustat, situation us questions patent you and I in understand for I have First roxa if could for exclusivity help the

noticed what your to timing And the you And what about? of was pursuing you thinking are in that this then multiple the you base ways for X Or is are case indication? excited are so for a any XXX, are Phase potential a program? ADC generic also why the exclusivity? you entry? there myeloma, And the Thank And about I have you. a there are this also in other X, Phase opportunity well, indications extend

Thank you question. for your

to I'd entry of to related for exclusivity, Chris China The term Chung a question. that generic patent first roxadustat like part address it Chris?

hear you you. Thank Can Thank Thane. you, me?

Yes.

the We China course. confirm for you a of applications has number of Authority roxadustat in for Thank that generic Okay. question. accepted the Health

filing. administrative an commence. means clarify, an represents just in form. technical to acceptance does Just not review. a any to It that It's of or shape is acceptance about a approval It

are patent not in until date. composition marketed that after in Our mid-XXXX any matter China, system of be roxadustat expires the expiry linkage to we expecting at generics given patent least

matter which defend portfolio, represents our to of composition many only have the one we intend patents course all patent vigorously patent we in that in Now, China. of of

after of should our although, of life is point Also, out, We price. optimistic brand front. a unlike on expiry. point at exclusivity In actually brand course, about the that the originator lower increases, U.S. some options remain in a cases, patent originator the for a I the volume there

options extend pursuing of period are property to that preserve tactics intellectual time. We and access market and

growth share there space future. As for market potential the robust you saw roxadustat tremendous in significant market that in we of is PKD. We alone earlier, saw increase in in growth a believe

Thane, get if would we market another sizable CIA course, it. represent back to were you. to Of

for to that Chris. Mark Thank about after if address that. I'd on question. the add to question we're then any to why you, about And Hunter comments John? like, has And related then excited, that XXX, John to

Thane. Sure, Thanks,

I a treat think was in monotherapy, one of to patient hard population. excitement the very really biggest efficacy of seeing points

these patients pretreated. were As I mentioned, heavily

And, XX%, we a good PSA very saw partial response rate XX of about rate. response

at. quite that was other that to are exciting So relative looking assets we

But mechanism had five ADCs that very is MMAE - there validated the mentioned, think are the approved I well I as use also, as now payload.

we dive did CDXX tumors couple that a expression. when part we with Additionally, the really saw any tissue showing into normal expression, deep quite of for considerable a to restricted only was most it

had we very to an So, we in. entire it that excited we package were bring very felt looks good and

talk then to to I'll question. turn about essential over Mark think and indications I'll multiple address other I the myeloma it

We are, into. in fact looking at indications to expand

in enter indications patients to trial. where can We CDXX run high a as be not have to trial prevalence that solid we tumors have where select from into a expression high, an ongoing who use be do translational might other may to medicine effort to identify BASKET we IHC but antibodies of able the patients, that expression

very are efforts. early These

now I'll for Mark, hand additional any you to So, And progress. as will comments. hope it to over you we they pay out

monotherapy, which is study in in UCSF One as castrate-resistant FibroGen. is mentioned. the at prostate combo I current about I the into ongoing you cancer excited add I'm because John. what ENZO molecule other Well, ADC, potential ways think is, also to help thanks, a - very therapy, you one mean, because patients or really to we're as several value it the metastatic has said an

one tumors other myeloma. our either solid is and/or The multiple

seem by multiple driven So, diseases novel CDXX. be to This ADC. is very a

that strategy PET Imaging parallel we’re a have We pursuing. biomarker

a novelty and that's exciting. a there's this think very I biology deep underlying So program

related Fortis deal four-year terms over conclude acquire to about spoke million maybe with to upfront consideration, milestones to think obviously really potentially company success-based in of the to for a $XX evaluation and I just opportunity. and about, asset And we're is favorable what excitement just the excited the opportunity the no addition cash the period John the for Mark

for exclusivity any on I Can CIA you. indication Thank approved? when, Is your gets there up one? extend roxa the Okay. first way follow after your to

be we have about At in time a is itself law that yet should there to property not been was point how intellectual in The amended this regulations it? China. So, So, First XXXX. law fourth thinking implemented. activated

So, we the decides decision I to those with are would eventually company implement. come looking at down to Chinese what the think - a opportunities

Okay. Thank you.

Welcome

for next moment One our question.

question with next question. Werber from of the Cohen. of proceed line TD Our Yaron Please comes your

Hi. much for Yaron. This [Ph] on just is couple question. us. Maybe Joyce so taking a from Thanks for our

about come a then, your the could for CIA. Can latest study, around to survival well. is thinking the surrogate if just ultimately use to U.S. a you're First about China going as to be quickly you us approval. only of you. strategy? the that tell event-free on is the thinking LAPIS this Or you Thank going this potential accelerated for remind us And whether as

CIA, And opportunity. LAPIS? Thanks to as right you like is on of Mark, Yeah. only Joyce. Related China the question to would touch now on a

question the overall to primary do endpoint survival. which is had so Yeah, the the with of study,

event-free mentioned did interim analysis a not bar call, a survival did that high very surrogate potential meet As for an analysis. an do marker. as earlier was we in It It we analysis.

first to survival the overall next for expect we the read the year. primary So in half we're that of endpoint. continuing And as trial out

you. Thank Okay.

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Thank you.

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you. And Thank abreast going look so, maintaining our of and accomplishments forward forward. we engagement to keeping the you

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

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