call. full-year quarter and Thank to our everyone earnings you, Mike. welcome XXXX fourth and Good afternoon,
to CFO intend accomplishments XXXX will I of our On provide financials, for today's a then for the open recent after questions. we and your will the important call, developments Graham, summary and review Juan call high-level months. which,
Slide of unresectable on one, to Phase in significant Number and pancreatic create delivering is areas dystrophy, X executing idiopathic advanced three shareholders muscular patients three X. with cancer. by focus. pamrevlumab pulmonary Starting pivotal value indications, FibroGen and high-value fibrosis, Duchenne positioned locally data for
patients disease increasing ensuring Number innovation two, productivity external opportunities. explore research advancing were that internal pipeline success for our programs leverage the while Number three, by expertise continue indications. approved, kidney and with additional chronic roxadustat in to commercial novel of access additional
pivotal an expected on enrollment additional two Topline Slide trials of pamrevlumab clinical X Moving this data by opportunity. XXXX, are represents for we to X. year, and five Phase both multiple and catalyst-rich In for FibroGen roxadustat. completed an exciting mid-XXXX. trials
progress showcases pipeline. capability our deliver our our goals on advance And to and clinical trial
are launches, for patients. include outcome preparing scenarios deliver ultimately, to filings expeditiously regulatory which these therapies We various multiple trial potential and clinical could
a continued options position Operationally, our array over plan, execute discipline, as on financial strengthen have wide and we opportunities focus for we strong our are cash importantly, we time. of a to position financial consider prepared look a with to and well to
Orphan have of X. Starting all these Now, I remind both our Disease on we clinical let's for trial move indications. timelines to Fast-Track three everyone designations FDA to Slide that want with FDA pamrevlumab. and
need significant Duchenne unmet or each DMD, medical diseases advanced muscular IPF, and LAPC with pulmonary potential and pancreatic Idiopathic of fibrosis opportunities to locally patients. meaningful the represent or cancer improve or unresectable lives are dystrophy
in patients XXXX. trial of LELANTOS-X, second from in pamrevlumab we expect DMD with chronologically, our of Moving data the X non-ambulatory top quarter line Phase
DMD with third our from from trial XXXX. in IPF ambulatory in Phase LELANTOS-X our data Data line patients mid-XXXX. quarter the X in trial of ZEPHYRUS-X, Top in
out looking next Now, year. to
LAPIS Our to XXXX, is ZEPHYRUS-X the of finally expected is first in mid-XXXX. Phase readout our in cancer report study out locally half IPF pancreatic patients and expected with to advanced X Phase X trial in
addition, cancer, pamrevlumab not Network's the adaptive of Promise Pancreatic although with PanCAN the to metastatic for with Cancer Action combination trial platform in slide, Precision patients care on In progress. standard evaluating continues pancreatic
with common a the three pathophysiology are all a there IPF, common different organs. is affecting But we question between diseases, feature A and trials. receive of read-through is with different LAPC any whether very pamrevlumab fibrosis. DMD each unique
the characterized IPF, causes which fibrosis fibrosis disease. irreversible feature oncology And tissue damage. is a genetic fibrosis in is LAPC in in muscles. is progressive and an associated key In of by disease the DMD indication rare pediatric the lung a tumor
believe these differences efficacy to in read-through limited one conditions of is pathophysiology, there others. from we on the no disease or Given these
to pamrevlumab studied the On dosed been event adverse seven safety safety and and in side, over favorable patients X,XXX patients, a up has has who in have years. been including demonstrated for profile,
X. of X bottom the Slide anticipate data anemia chemotherapy-induced expected with as from MATTERHORN anemia Phase second patients on patients study and trial in We in syndromes China XXXX, of the second to XXXX roxadustat on the from our timelines quarter Moving myelodysplastic X well. in the with in the quarter readouts or Phase
sharing the caregivers for to these investigators year extend to patients, we This of I and and colleagues FibroGen few antibody. their monoclonal opportunity FibroGen pamrevlumab, be like we results a well commitment. with as wholly-owned highlighting of look my view studies. see to minutes to I'd will the now a would like our gratitude as my transformational significant spend forward our commercial for to
Japan, our with than more past prevalence of opportunity a With the revenue diagnosed in global billion detailed be IPF and net calls. will in opportunity across approximately Slide two together XXX,XXX patients U.S., XXXX. IPF in almost E.U., view China on generating Starting I perspective on approved a a significant therapies $X X. the of represents providing the
and therapies size as characterized the with antifibrotic there by remains approved the need an unmet two growth progression and Despite continued of market, tolerability. disease IPF important the challenging
current for the community the treatment believe has with IPF become we sizable potential pamrevlumab sentiment product relevant number There have therapies limitations patients, help of of the to IPF. of a in a and is a the
we highlight IPF where therapeutic to lung disease that As from options. of resulting in could high progressive tissue, morbidity patients Slide irreversible IPF X, loss new in the benefit mortality. leads function, we fibrosis is lung believe a and on
IPF In three to fact, diagnosis median survival following five is of only years.
loss The X. of characterized. into This tolerability depicted current lung on well as challenging the slowing along options limitations translates low a the effect treatment of are a profile. Slide right treatment of Having with side function, modest rates the on progressive
with these XX,XXX newly-diagnosed prevalence XXX,XXX each we diagnosed Of patients approximately one-third there U.S., the approximately estimate with of these year. patients is treated In a an XX,XXX only patients, are anti-fibrotic. about with that patients IPF of
one sensitivity. usually started standard-of-care of two early includes approximately and given diarrhea in XX in for due proportion also roughly XX% of And and diagnosed the XX,XXX first year; these to XX% discontinued severe this to which progressive large a the patients effect, months, approved anti-fibrotics treatment nausea, have of condition. patients side the treated IPF Resulting U.S. a being with in not
to who and to this with IPF has for significant as patients, stopped addition effectively the those potential options. well as to be treatment antifibrotic unmet treated important tolerability. challenging existing Because antifibrotics, an newly-diagnosed have have need, Competing patients patients, believe for current we treatment pamrevlumab been due who not of
locally with significant Duchenne Moving advanced unresectable X. on muscular Starting opportunities. each in column. the and pancreatic dystrophy to cancer represents DMD Slide left
by the needed the an of hopeful the that disease are desperately LELANTOS progression therapy is DMD program DMD can the nature to of Given Phase devastating and approved we community. relentless X that lead
a While portion approved symptoms increase that small therapies only in have of an target clinical DMD patients, the yet demonstrate currently meaningful to improvement levels, in exon-skipping they a disease progression. produced or dystrophin
treatment progression targeting improve need the muscle ambulation. downstream patients can attenuate under five. therapies antifibrotic that can these and help mechanism We're disease of clear hopeful is function pathological to by DMD maybe There pamrevlumab, the prolong that for changes a
advanced LELANTOS-X XX functionality function. limb primary test, hand. primary performance six measure ambulatory with non-ambulatory DMD enrolled is years The and is is disease. shoulder, the of North elbow, ambulatory the patients; of endpoint with which disease. the advanced years to of older upper more assessment XX The and enrolled DMD wrist The measure endpoint less LELANTOS-X ambulatory patients a old which Star
is column, of over of prevalence right-hand cancer snapshot antitumor largest cancer. the with opportunity. both XX%. a a low We are cancer as the trauma. across the effects of that advanced patients one we given disease-free evaluating pancreatic show pancreatic represents on locally around major why believe the survival diagnosed metastatic five-year of as oncology, XX,XXX both well Pancreatic has rate regions This effects we unmet In pamrevlumab that and LAPC the needs in direct combined
over immunooncology meaningful pamrevlumab, standard-of-care. the can significant the last a been have demonstrate to advances There creates over in demonstrate it benefits two therapies opportunity with failing limited survival. overall survival This improvement potential decades if for a treatment current
roxadustat the CIA myelodysplastic MDS with on China. treatment Phase in anemia treatment X. to anemia of of for in X in Roxadustat the trial move in U.S. for update the patients on the is Europe. let's syndromes, Now, Slide And and chemotherapy-induced clinical or currently
Starting to XXX,XXX are marrow. blood abnormal the that development occur year of group XX,XXX cells U.S. patients in MDS estimated with rare of are within patients than with prevalence because the XX,XXX And myelodysplastic a diagnosed and between It syndromes each U.S. the more estimated bone is or that overall in is MDS. MDS of disorders blood be
approved XX% in present patients to medical launch MDS causes More diagnosed time fatigue, illustrate of and breath, lead cell blood can when complication and luspatercept its over transfusions. was dizziness major with a indication, is red the successful weakness shortness unmet and and Anemia first need. of recently, this in frequent
in We Phase trial expect X of global from quarter data MDS XXXX. second topline MATTERHORN our the
second expect quarter China trial Finally, X data chemotherapy-induced anemia from Phase XXXX. we in also topline of the
to want pipeline. to take comment Moving early-stage I a moment on and on Slide XX. do
FG-XXXX expect in tumors the myeloid XXXX. immune T-cell resistance INDs leukemia. an of responses. cell And populations. immune is directly to We are FG-XXXX in solid leukemic anti-GalX has many file inhibit to ability developed target-driven up AML, preclinically progression reverse characterization been acute antitumor cancer that second is GalX-mediated for prevent to death to of and its two target to cell half critical in for undergoing subtypes shown antibody,
responses tumor selectively FG-XXXX immune without cells T cell and in FG-XXXX regulatory is to microenvironment without an suppressive disrupting activate anti-CCRX broad peripheral induce has killing affecting Use homeostasis. antibody T normal designed potential tumor tumors to deplete the in solid cells. regulatory immune of
HIF undisclosed development leverage our biology. Additionally, we have CTGF that expertise program preclinical in and
in to continue growth to China XX. on Roxadustat see now moving And robust China. Slide
XX%. of distribution growth $XX.X by We XXXX in sales of was of to This net year volume XXXX. full growth in quarter joined are million $XX.X increase reporting $XX fourth was total an FibroGen XX%. and an compared the over by entity was driven million fourth volume over increase in China quarter in by for roxadustat in which net sales driven of Roxadustat million, China
FibroGen's the portion net in a XXXX on further for roxadustat the revenue the Juan for of in elaborate million basis. fourth quarter product year financial U.S. GAAP will $XX.X million was $XX.X update. China full and
Slide on growth of the Next. XXXX growth XX, table roxadustat. provides On indexed note, as chart on the as as of a growth December right. there's in well Slide a year-over-year snapshot roxadustat Of on left to unit XX the unit the significant
up leading the in is NRDL brand market roxadustat XXXX. since or driven slightly, reflecting CKD While been has the its expansion anemia original by that ESA listing
turn for Juan the CFO, Graham financial now to update. call to going our over Juan? I'm the
