CCXI - Earnings call transcript Q1 2020

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Operator

Good afternoon, and welcome to the ChemoCentryx First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session.

As a reminder, this conference call is being recorded.

I would now like to turn the call over to Bill Slattery of Burns McClellan. Mr. ahead. go please Slattery,

Bill Slattery

its afternoon, Results to afternoon, may XXXX. call, you are of the Relations Conference press overview issued Good helpful March available quarter the Quarter slides the ChemoCentryx XX, XXXX with a of the few an listen providing Financial section Call. release results and you. for the first at press welcome on First company financial This ended while Thank Earlier www.chemocentryx.com. company's along you release, a that find this website to Investor this

me Dr. of and Joining on the clinical Schall, the will who is call company's Officer Thomas Executive business and today progress. Chief review recent President ChemoCentryx,

will Susan Following the Kanaya, for first remarks. financial to of Executive the his highlights of company's closing for and over XXXX call comments, back ChemoCentryx, the an before provide Tom turning quarter Chief overview President, Financial Vice Administrative Officer

XX, cause annual contained report call, to following and forward-looking involve which company's based of on Form These company's making are we actual X. that number These current materially certain statements filed During can be to change from look with subject differ Slide XXXX. the March that those made a filings statements, you assumptions risks information, uncertainties slides if the on are described and Commission, Exchange forward-looking in will the including may statements. at today's forward-looking the the results you risks expectations in Securities on and are of and those see XX-K

any forward-looking obligation these reliance disclaims not to ChemoCentryx You to statements. are cautioned undue and on place update such statements,

forward-looking XX, this as of broadcast, accurate information this circumstances of that this any no revise statements addition, contains May conference live undertakes the to reflect date conference or In after date ChemoCentryx to events update only the obligation of or live is call XXXX. time-sensitive call.

over the is Tom? Tom pleasure to to it Schall. time, this turn my call At

Dr. Thomas Schall

Thank reported since listening. the XXXX on you XXXX everyone our It months year on to world first quarter you afternoon call. good and conference changed I our us to for How has X Bill, then. since you, Thank results. full joining only is

let sadly, start, who The and crisis express workers destruction ones lives. to deep and care a are reminds importance of sympathy have also especially heroically suffered who those during those fundamental from we adequate to have gratitude remedies loved and to all lost short this I we save current battling Before heartfelt who many me even pandemic in my the world my to are afflictions. and us have this how depth of for good of far health health which

biotech need wonder in of has strides life no continued more the progress clear sciences recent classified companies the as essential in decades. Never are the innovation businesses. It's despite we the great taken been have has for

Our passion from discover, dying and serious novel diseases. to those bring and is develop suffering medicines to

The or ChemoCentryx given platform, inhibiting chemoattractant autoimmune can precisely Slide or a based disease. selectively on from for receptor X, you specific destructive is as a inflammatory see

whole the current system. entirely we the of do suppressing and this unlike most therapy, without Importantly, standard immune

word A our has COVID-XX about affected the pandemic work. how

on-site changed? has scientists First, March, team of at such as colleagues, team headquarters. and Operationally, what to other a our only community, our core our and since our essential physically are protect lab working personnel,

policy. work-from-home we is business a Overall, implemented others, For continuity good.

new ANCA momentum, and for Our our drug for NDA, vasculitis, avacopan readiness Second, timing what has or application, commercial campaign. launch our filing the not changed?

supply that developed to of batches chain underway, are are already result far subject so we example, as a not have interruptions of avacopan For and COVID-XX.

launch We in ANCA we enough are for avacopan commercial that have confident vasculitis. a

in unaffected largely a will I been more as in explain has progress detail moment. trial clinical Our

we remains supplying were we our set sheet While are suffering coronavirus diseases our and targeting, to the fortunate in clinical relentlessly from balance near momentum pandemic diseases. are in. fuel enrollment began we or that for current we part the at also of our serious need trials, of the complete of seriousness Yes, orphan of in this full cycle reflects when the to impact patients pursuit continues, strong, relief this drive forward of

data introduction that COVID-XX with vasculitis, year, I'll impacted X set has our a on clinical XXXX program you to With business, and readouts how X-sight and our our previously forth on executing the further this top ANCA moving now progress in of then on studies. starting update goals line from avacopan

As desperately of ANCA that let of risk. and for standard this disease. adds why avacopan I ANCA to current ANCA owing treat immunosuppression crisis. remind patients the is high-risk to is mortality the people. Sadly, to more is Even deadly that vasculitis in highlighted carry on shocking current shocking therapy are they Slide considered ninefold is X, actually to COVID-XX, healthy patients therapies risk turn increased on part so the needed. care ANCA-associated broad new current compared Many mortality in a me you a how immunosuppressive are to

relief be But on way. the may

track, avacopan FDA and to this on file mid Our schedule we our year. continues on are with dialogue the NDA for

confidence proposition trial III in we This the in most this ability an sustained steroid-containing target what for powered we of was be and total the of remission revealed in exceeded each all-around the of that to is the care trial achieved treatment in will clinical meet trial high with form demonstrated ADVOCATE versus which disease. ADVOCATE Overall, avacopan grown that results to that Phase It current reduce during superiority. compelling week to year burden pivotal and passes. since statistical has confidence standard consider X avacopan founded the the ANCA-related expectations of the was ANCA is not group. disease start value Our with for a superlative a upon superiority

to steroids, XX in actually contrast the improved quality into Notably, beyond sustaining and that relate of quality vasculitis in in hope and therapy. in associated touch remission care. significantly the bringing unprecedented of the of significantly symptoms function paradigm effects on illnesses a remission, in mentioned life life, are use above, therapy steroid-containing over ANCA communities bringing addition, people those of and patients improved the standard of as clinician field, the ANCA the in disease the for the kidney Members avacopan of reduced with deterioration new weeks patient

Dialysis We the share meeting, the at at trial Rheumatism, plan Transplant to expanded or Renal or meetings the League annual EULAR, ERA-EDTA. Association from beginning month of next Against Association ADVOCATE data major and the European and European European

peer-reviewed forward additional We also publications look starting year. to sharing this

preparation in avacopan launch We commercial for potential are the our gearing organization of the in up U.S.

we quality, senior research service as access, health. added resources of the as chain, tech the new months, operations, of and supply we new making patient the and medical in hires the commercial dozens access, Since managed operations X well Our including have ranks other maxim ChemoCentryx. areas as have such is and and innovation patient affairs, growth VPs analytics, start for year, in key human added of new recent to of In example, executive in market management more. care professionals

these highly of and our professionals commercialization of readiness XXXX. mission achieve in to launch intensified All of avacopan part trained are

XXXX X-Sight Turning X. program, Slide on now shown to our

CCRX annually LUMINA-X the each is glomeruli, can a and even our administered FSGS. units, over tens orphan scarring lead announce FSGS treatment during focal the in patients. glomerular disease, results characterized disease kidneys' in quarter inhibitor, of alone transplantation. new segmental it in to selective approximately kidney the is this study condition by CCXXXX, indication from this to year requiring FSGS the expect FSGS XXXX afflicts renal of the of in dose-ranging thousands There end-stage with sclerosis, line filtration also dialysis people or top cases involving We that orally are transplants country. an kidney U.S. of XXXX the or

orphan suffer U.S. CCXXXX proteinuria. system drug FSGS. There filtration patients in as from their The are protein no been urine, FSGS. approved designation impaired, in the has company's drugs excess for With yet for the granted

a standard-of-care X can impact see out using you and controlled from The set at we medication baseline alone. to background expected today. XX the results background X, medication to a with doses a Owing the line primary to randomized, compared end in the reduction trial on proteinuria commenting be primary entry. added As efficacy will the Phase top FSGS. the is trial not in QX, XX LUMINA-X measure of study patient's of in weeks LUMINA-X time to to Lumina-X release trial The different dose-ranging when after is CCXXXX patients of point of II compared Slide further

is are, ill our with second our study, who of study study greater a a part identified patients LUMINA-X is mg sicker, to FSGS single X-Sight mg intensive This syndrome, Patients doses day. as nephrotic considerably The typically generally and higher LUMINA-X receive a a condition or condition expect, higher trial. open-label arm, CCXXXX of program grams intervention. than once-a-day known patients very you much is also a requiring as in day. proteinuria and are rarer X of primary twice from per the of baseline much XXXX would quite FSGS medical escalating XX X as

line second report on top track results to the this of are in We half year.

forward and Slide X. avacopan to to back Turning

by than skin treatment are chronic, neutrophils the trial Phase by severe for disorder CXa action receptor, all The CXa. a to by disfiguring randomized II the that AURORA clinical have patients thought that of We the a exceeded to remind the placebo-controlled trial of arms. X AURORA And activated patients enrolling of HS our are thereby X is disease, preventing double-blind, I be skin receptor. suppurativa. disabling more hidradenitis CXa who trial target of activation moderate by driven XXX is HS with avacopan's of the to neutrophils is destructive blocking mechanism in

clinical be The the end using or suppurativa weeks XX HiSCR. at will response, primary assessed point hidradenitis

sites of on and During open reflecting sites monitor crisis, is of regulatory HS year. for for that life-altering the majority stayed continually track a and data. study ensure particularly HS are agencies of line data third disease. safety patients, clinical individual closely visits the progress the top this with our patients and this are We this release integrity devastating quarter of in in working and the fact to the have part we The COVID large to

patients kidney The studied placebo-controlled orphan approved experience is disease are failures. the ACCOLADE Phase of fourth on versatile being a for X-Sight the the all in complement CXG CXG kidney ACCOLADE quarter's strata There also glomerulopathy. II disregulated rare our program the of trial X the options. XXXX those Slide have CX disease, are in on X, call. blinded avacopan patients in more kidney there I'll of depicted trial, no and which, next with the clinical details again, Half treatment is

that rarity the controlled blinded, randomized, experts indeed belief trial way clinical the definitive powerful the disease, asking because CXG. will of CXa whether is data benefit I this for our CXG have of largest, largest, receptor this analysis The the clear from the already a clinical trial. to is amassed a to one the of data and of a CXG there's perhaps targeting set answer as provide in believe the Given we on community forward

of protecting CXG. Naturally, the there rigorously Given FDA-approved context course consultation with disease could devastating regulators potentially and will the it integrity view be defining of discussed with rarity and to its in are essential support path. a therapies, in conditional that the no fact database be are the for that this we this the registration

for of started this the are today care the health gratitude who frontlines expressing I on workers by pandemic.

dedication. their patients and efforts, of the for Susan? closer we let on colleagues placed frontiers rewarding by all Susan my the to who medical close us. clinicians in dear and their helping to also moving have the the their science call at goal shareholders over for very Kanaya me turning also of financial who a ChemoCentryx results, thanking trust are ever are Through Before

Susan Kanaya

Tom. Thank you,

for the period quarter XXXX quarter quarter the $X results development Revenue our $X.X release same Our in Research $XX.X first million on XXXX compared Slide for to today are year. and for same included financial compared the and XXXX. first million quarter were X. of expenses press were million last $XX.X summarized for in was million first the to

now associated with patients partially was IIb clinical patient ADVOCATE enrollment increase avacopan completed to trials. vasculitis. and Phase costs III avacopan the offset This increases the with application in AURORA drug clinical for trial LUMINA-X by preparing Phase II due in Phase expenses associated and the new lower HS These in primarily CCXXXX ANCA avacopan with were

higher were $X.X the for in to increase first last including period of those The compared primarily employee-related $X.X million our with General and was same expenses year. to the due expenses, XXXX quarter administrative first million loss quarter net compared of ANCA and million the the $XX.X quarter recorded fees. net launch avacopan readiness vasculitis in of higher efforts professional We of loss a a for to $XX.X XXXX. first associated million

million XX, million the shares at with and quarter Tom? $XXX.X were closed and XX.X we Total investments. reported XXXX, cash outstanding March in approximately shares,

Dr. Thomas Schall

as see for getting this close And ANCA on Susan. To with you application Vifor goal filing are FDA. plan to of we our NDA U.S. you, later a to summarize, licensing Slide Thank submit can XX, the Pharma, our in partner, year. our vasculitis avacopan the EMA to

We U.S., up is our for organization markets. are preparation making international commercialization the preparation scaling in Pharma and Vifor in for

the X-Sight which starts we the program line study the The data of year. results, of half of top XXXX announce current this second are Our expect with to the quarter. LUMINA-X expected in in results LUMINA-X

AURORA to avacopan HS, We in have release patients exceeded in with quarter, line enrolling next our trial of the top data more target than plan our XXX in consistent QX.

end trial are the of enviable position. financial the of results also of by an avacopan in year. to We in CXG we the announce And expect ACCOLADE

even our of our firm. progress current last. contributions out crises resolve against the backdrop is enterprise The it of crisis. is pass, the At as But plays while encouraging ChemoCentryx,

Our irresistible and science forward, illuminate where for propels health our the see and in for ineluctable shareholders of bright prosperity us medical patients in innovation. fire burns for drive our future The the determination to discovery, our to need we alike. our

now will turn that, forward to your With Operator? to I operator the look over call the questions. back and

Operator

comes And you your line Raymond first from mute. be question line may on is Seedhouse open. Instructions] of Steve James. [Operator your Steve, the with Steve,

comes question with the Genuity. next line Gilson Your of from Michelle Canaccord

Michelle Gilson

hear guys you Can Hi. me?

Dr. Thomas Schall

Yes, and you. Thank loud clear. Michelle,

Michelle Gilson

for was we I'm guys kind you you of that bummed thanks for Susan, answer I that new into move us the for for for question. gating remaining of hi your guys filing But can't into taking head you avacopan this my year. are hoping Tom, what could facility. the as Hi factors middle

Dr. Thomas Schall

document, you, as imagine. right on can well a Michelle. It's massive We're Thank plan. you

in has kind progressing it just we're indeed at talked been progressed that exercise have we of There point. of the action Things are we mass extraordinary most about items. So no a this gating nicely. very past

as of any as So path in have the hang-ups we all know, the well. we gone no and CMC critical far like have areas.

the in I a of So our up the right say of rest it's package that, buttoning certainly matter filing for yes, now, midyear just time and would deadline. it

Michelle Gilson

that's really All just And and obviously, is done by also not HiSCR hidradenitis trained. right. on assessment be suppurativa, can't score a anyone complicated

HiSCR of if score sort was I suppurativa hidradenitis So wondering any just you're foreseeing for the complications in study. assessing

Dr. Thomas Schall

good and times. Yes. apt very these question It's very a in

bit So training fanatic absolutely in start been HiSCR I'll about pass our to they and certification the a of be things creating that the and to about also to of had score order continuous the and of patients. couple obsessive started use to have worked before in it's say were encouraging how favor. in the and back up people enrolling we a a able very little the study, We've records. done, standardization other worksheets we

of the HiSCR to inherent to is the by of variability All eliminate control placebo and response. certainly some trying this of way in

And those blinded out. the the we if done terms the we on And them go data investigators, about the doesn't they as assessments. make indeed, HiSCR, monitor something inconsistencies all monitoring of medical were, phone with the and sense to work our is they back of in HiSCR blinded, So during came of part and blinded determinations, in been have things. we've fanatic those

obsession, of and the monitoring HiSCR, been has Standardization is been score like training and object normal hope have key extreme. feature. In blinded which has we phase variant, to ways, well a that. an been of the another within has such meaningful variability So during a

subjects the point your the majority very had to that pandemic. and question, of trial enrolled the part AURORA major of fortunate already end fact, in the primary rest we the in had, our XX-week in passed were of To the prior

primary data more get by power for we captured we as a enough So to although we have had already planned. us, reasonable the the point end collected, still to ascertain the to know trial way, entirely will data end primary knew even point we blinded we that the in the data, but

obviously the of effort will minority also stayed other to for things And every because sites have determination will that HiSCR, sure worst-case doing weeks, example, the really point folks on primary that's making past happen progress like HS now not we good know, end as yet open. one. those or number come that have to make XX pass are of to planned, made we've And that. for majority was the which that scenario, So we

For, to but occasionally, ways telemedicine, HiSCR, for, one been there's some breakthroughs perfectly, do even are not the there there. with as admits,

been the we've with determinations. some on will advising will where And around agency care health say, issues we've be and of I HiSCR we've availed worked that well. where carefully guidance visits agency too, home there as any ourselves

supposition will adds on have All our efficacious point. whether that the reasonable the part think, of the be the I matters date up on to based to XX-week end evidence this drug based is determine to, to we on that primary HiSCR data able

I we're with So pretty in feel good that. shape

Michelle Gilson

Great. Okay.

curious if one case I do COVID-XX studies for be have avacopan studies I I we've you know testing CXa more, But to implicated. patients clinical may now? Just supporting on you call, if last how in some you're patients just the see can. if your testing the was talked about mechanism right there. Are this

Dr. Thomas Schall

some or program testing we're testing avacopan will results formalized against into in entered retrospective not we If same. But a analysis. doing Michelle, they're getting and be formal for records, COVID-XX obviously, incidentally do of antibodies our no patients, either got for We've likely no, those the studies. tested, could study

I the that's avacopan the say to all about have with work. ongoing So studies

as might And as CXa potentially role, been damage. and others lung one Europe, whether certainly you have in COVID considering deeply a of mechanism the we there in potentially, the a but playing CXa programs, receptor are we've U.S., interested two, know spotlighted unproven involved couple of in. and keenly one in very get know, been are and We that

so not there than At we'll far, that But we may agents. community decision. anyone had the opt community if this doing lasting more we work, a longer opt to if hoped, the we to appraised but bit this a we'll is crisis have be to some point, so made keep so. with done not work be involved. we're careful clearly, alert and certainly do But get And certainly, clinical novel little

Operator

from the James. question a have with You of Raymond Seedhouse line Steve

Timur Ivannikov

you This for hear Ivannikov is Steve. Timur me? Can

Dr. Thomas Schall

can you fine. you. We Thank just hear Yes.

Timur Ivannikov

sorry Yes, difficulty. Okay. the technical about

about we So HS had a study. question the AURORA

you You Could talked HiSCR been exceeding powered could for? what And in a problem. rate you dropout about by expectations. the whether it's enrollment remind But was just talk about us hasn't COVID-XX? impacted delta been I'm study assuming

Dr. Thomas Schall

good Very question.

rate to under to, the point. an doses, detect XX normal the in We as as alluded week dropout folks not, I XX-week meaningful blinded end not probably, trial already go point, the the term, primary know, practice, to in open-label should over the certainly should and they're dose. our end although longer phase, So they're point two end the ability you even affect up to difference a after into primary

the or as less actions were more So there expect XX-week that, think, don't quite the not said there, will data Having as a be weeks, I in as we affected which from predicted. understood. have and first only will And COVID, be period. had do to dropouts be there XX I be rich to dataset owing additional the is major to mentioned, to additional

large XXX than power. difference is a look trial, patients at greater XX% three powered groups, this obviously, HiSCR in XX% with a have, we So, in about to

a we, between would Phase of individual plan, analyses the additional placebo, ourselves even versus of adequately So in all the be think on power, to III greater we're stats if really the of arms I that avail any pooling And avacopan. patients dose level. powered

So powered. it's highly

during very monitoring And as HiSCR I we've been obsessive training, the phase. said, blinded about standardization and

clinical So see I'm response we'll that to a one. quite we confident be determine able if

Timur Ivannikov

about other potential Okay, And question so COVID-XX great. -- studies. Thank it's you. our

initiated of potentially and You have make maybe involved, considering? clinical the the you're have complement that getting not in at looking companies will mentioned and is factors you in you. you're of that in that sort study talk seems about Thank COVID-XX. Could you yet minority now involved that it some of get the inhibitors a ChemoCentryx programs

Dr. Thomas Schall

and it's very question. important interesting Well, a

I other we important there our that intervention the -- complement think are we special interesting involved, to notwithstanding our So that with and a may -- ChemoCentryx, are get sometimes certain are be special timing of hints have happening although that things certain companies circumstances in clinic, respect program.

just and interesting we've applying licensed, yet trial completed results large So license. not we're think, positive for drug in I vasculitis. as just and, you important ANCA is now pivotal very The yet first know, the our first with

known in its from something So consider to the disease, help people timing ability trial equation. a large obviously data with with set randomized of is the avacopan controlled we and a carefully

us COVID Moreover, I think well. the biology very is to interesting of as

But so, acute acute there reasonable in this certainly some the of hypothesis cytokine very morbidity is And defense, mortality injury it complement is that true lung related part is consistent viruses, being respiratory kind distress storm. with also the involved driven host that including of so-called fundamentally, syndrome viral of host and and yes, defense. the by is other and the complement neutrophils activation virus in

So fundamentally is one is of whether believing But one or think one of the yet obviously, strongly timing yet hypothesis is don't a, the knows, even intervention mechanism knows hypothesis if precise in. And the very, no key. timing excellence, is world driven anyone not intervention about very certainly, the level in that the of the I evidence. at

So controls that evaluating whether very collection, evidence be designed careful now. we should much It careful And very study with comparisons. We are more clinical one were that the been point intervention. multi-agent carefully the and I think, believe we a and has will already there of around better of are, a couple UK, believe programs do one, do of is in there's agents. a that approved be they there data

careful constructed. for studies allowed protocols of be designed to elapse careful the and has more more time So be to

that not that us. it's to us also to. study for a a and our -- handle make time more we could or data COVID good lot intervention devote programs, now package the And have whether interesting very to we interesting can to something on contribution is that other we a we meaningfully certainly that's So attention

or that crisis. think among moment of not while first companies I contribution So those intervention this very been at I evidence we've the were interventions, first get And board, those really I acknowledge early whether of we of yet complement that about what from jump kind other important approaches some have applaud very to those and good sponsors, the to in is forward. the across way the with

So evidence bit a maybe of a little trials. such how bit little to we have more now, more understanding manage

we And at we're and this the day-to-day if involved useful whether and involved in analysis so the in can evidence it in trial our information yield opinion. appropriate time, and is discussion, be based said, as the scientifically I will,

Operator

comes Your Rama next from question the line with Anupam of JPMorgan.

Tessa Romero

hear This doing all well. for Anupam. on to is call the Glad Tessa you're tonight

next Can Tom, on data? paying plan, us, mentioned from data attention just we to? to we at analyses what ADVOCATE key remind month. and you Any additional subgroup the ERA-EDTA should analyses particular expect on one present guess you ADVOCATE, EULAR I So should be us

Dr. Thomas Schall

Great Thank you, Tessa. question.

sessions. the year the, We, been both the EULAR, of for ERA, confirmed as have fairly probably as meaning high-profile clinical presenting well be those of some virtual will guessed. But have investigators data meetings. meetings some in, I most So as we key think, this at

interesting line and alert will put as are we'll those robust the data certainly with be you form, because, details what we data, results the the very The everybody. in presentations as have and of be, when I top pretty out will we know, it's that soon clear avacopan. as think, So released very

very by one primary are statistically arm. [Technical job of superior XX in lots standard-of-care week good sustained remission sustained week in better the based at way remission, very a in sustaining point months. Score, of X significantly in remission the When at people looks XX, Activity under Birmingham a to end state. a They than the have Vasculitis Difficulty] on so people remitted at We numerically the

that's robust very So end that important. numbers are point. in primary The

beyond the doing at So well. you're analyses will you subgroup all the subgroups that can from we infer right, arithmetic exactly But top line. be looking are the

have diagnosis diagnosis we [Technical of that's auto of clinical other some standard clinical anti-myeloperoxidase, Difficulty] the know groups. antibody MPA. we And GPA. between [Technical typically always associated of is is background distinctions for So care with there's associated Difficulty] is the those example, with And clinical usually therapy. which two And the the again,

anti-MPO disease much dysfunction, so we'll to kidney manage looking patients, related well. and as with MPA more antibody is intractable highly that hard at to very be

So to with it as background relapse it with So out in know. coming therapy well details the avacopan cyclophosphamide diagnosed rituximab? newly will work as want and that's of what Will work physicians Will with work those be disease? disease? GPA subgroup MPA And will or analysis.

at Again, preview. I'll just week avacopan give with a quick The strong arithmetic so XX. is

everyone that guess does well, they and can do. You

standard excluded should opinion, diagnosed of discussion or people therapy, either change the get tantalizing licensed. realm my avacopan the of are that will episodes around and details from relapse. become in think, fundamentally, But interesting episodes newly ANCA of that subgroups, some be, severe have should potential of very the one I should no and, care the of should vasculitis, with out So of major it come what

I really think change these I data show, inform it. and, believe, to are really going that they're to conversation going

nothing be kinds superior think and look end that steadily details a to weeks and, I over life those out those significantly Toxicity EULAR few more secondary points, ERA and will just as prespecified quality of care, again, XX fleshed So a in for the as we reduction of function in of the things of standard glucocorticoid-related increases renal Index the improvements little to you metrics are say can the effects. on well the where, Glucocorticoid All the publications. showed bit at in a significant obviously,

Operator

comes Sandler. question of from next line Piper Tenthoff Your with the Ted

Ted Tenthoff

the great this you little just time if to see it's this a were up going all guys you breaking bit. different, apologize on a was congrats managing and through on, asked, progress, Really Great. question lot difficult period. I

AURORA, to could the to on hear with So sense would trying it What guys meaningful? here. a next as of some data? clinically hurdle to And you positive for what was potentially the answers. see what steps hard respect But just is get be

Dr. Thomas Schall

Ted. Those really questions. excellent are you, thank Well,

needs was had that It to mind adalimumab, there Humira. But to currently, or licensed. have keep limitations licensed therapy. are So some one and therapy, what before that drug an from in was they that's only HS certainly patients that anti-TNF advance one

are that And such is in rough after the probably only that data commercially Notwithstanding well year's important. in the population in a say on important, are it estimates very one no the they can as modest they're accessing successful modest fairly XX% population that durable of primary make modest. moderate-to-severe despite still time, durable that, most modest benefits, to would as benefits, fairly is question, still XX% effects. Again, based fact, patient community particularly some But the patient hidradenitis the suppurativa. indication that with that, penetration antibody very fairly

as there's know, huge it's an here. So moreover, And you opportunity injectable.

So want this. really clamoring what orally for they're patients is drug, really administered and effective an

So in really would I is, therapy say, the an advance desire considerable. for

XX% control versus showed anywhere trials meaningful, approved a Now the we got improvement adalimumab know between what's about clinically the XX% placebo from it that arm. delta to other controlled or only when HiSCR

meaningful. it's set up definition, way way So again, the regulatory and clinically that's the precedent looks, the by

that see one what set powered statistically a up be it's we a assure chance to have be people consider will the good we meaningful to clinically and assure that think for So I looking trial thing to delta. most to and we is would are -- we

are other built into things So the there trial.

actually will of to adapt to other the a have quality-of-life read conditional suppurativa will tried with we've experts be the challenges potentially areas. given a may That opinion hidradenitis the -- the mature be asset biomarkers, trials of seeing we there's the in about versus that would There there if of fundamentally, leaders with with and had be the discussion a we you see to orphan a next it more point. course. secondary placebo patients. And index would But what when think were adalimumab other the to about a -- avacopan as course, that's be tailored is be think separation key minimum, Of statistical order clinically meaningful. I at group unique end on there in I be license step, talk a group, if FDA out that meaningful we're

We drug get achieved stage, adalimumab. orphan been designation in for sponsor, data application the with discussion But maybe just given with robust AURORA process. early could the be a be that also orphan trial. disease X about whether yet an with not registration to designation. don't Now reasonable We've would X, should drug designation, we have AbbVie, or was other that

something and But if trial gives fundamentally discussion not clinical be believe had So that registration, trial are about for conditional very, you it's And there we any even clamoring patients could an positive, it that we indication. new, that good doesn't, do to is very if be Again, enrollment done. would think had I need a extremely this a is to that efficiently available. additional if particularly we in trial. orally

So a confirmatory trial, be rapidly and very efficiently. necessary, done if could think, I

Ted Tenthoff

appreciate. I Helpful. Great.

Operator

White Ed of comes from H.C. with the line Wainwright. question next Your

Ed White

what's care into done So just patients and visits. follow teleconferencing health great with detail on went you and AURORA up a Tom, perhaps home question, on the to being

like Just in anything any of that curious your studies. you're implementing if other

Dr. Thomas Schall

we of We being yes, the although, most for have. to us as particularly out patients, timing than but Ed. less at others. you, careful Thank we're course, be some turned In other the grievous of look studies,

sites. trial data look out closing obviously, focus, are in clinical you most and ADVOCATE done than So that few across finished was already programs the was the the conduct of other a if that

closures somewhat But site those the application do the to drug to those and in new delayed, needed yes. package, analysis the we and been collection data things already were compile So things process. have real

continued, hard of that registration working of those programs I've work evaluation, and are important sure filing those think, agency any seen the has a make going pace. very FDA that with programs. into been have to capacity also I in to not diminution The the kind at

the minimal time ADVOCATE, and into just developing. was just the CCXXXX, effect. the crisis visit or the trial ANCA FSGS So real about of around about with last avacopan patient fullness vasculitis, LUMINA-X, happening the

large So majority. collected, say much I'd had of the data the been

sites So the ends study, many working in kind different the XX were again, difficult tidying still of because the there is and countries. internationally difficulties we're in of that

affected. of a smaller we not folks X had intervention are but still trying hired There are we're been a that done. people. get any for lot have collected patients people to so study, affected not generally, in LUMINA it from the all are, study, they LUMINA-X longer But been because really is been X didn't purposes, the already and have a that's much data was and or data so intents that's X much longer they challenging on, little because more

the So they're coming anyway. clinic into

strangely So much. affected it that hasn't enough, too

some their a there, transplant a yes, are transplant, with, CXG, being come those had draws in consideration and was the carefully worked there immunosuppressants, in to main clinic. some But worked had of And if had folks especially work with we et visits been for particular, and trial. well. on things the make the cetera. sites in monitoring, able essential sure remote for to of X-month there have those take fortunate more we've That's on hospitals, are they've again, in with very patients cocktail that that out very blood whole visits, in even could at visits, have and them and since local And kidney their been safety

as data, track in I on combination all extent discussed. we that think, of do to, essential hope intervention, trial in the the has we're I all a say the smaller all, with as I been most that get we've a similar well. will taken AURORA to that, been really ACCOLADE in So take But we have trial fashion the to that degree, measures although had it measures to the largest the that to will the that

Ed White

launch wondering Tom. about physicians. news, I'm perhaps any readiness, then or question can That's you're just was Great. from now the avacopan good the initial for And you give just if talking care payers the even other feedback us the that companies, managed

Dr. Thomas Schall

great to say the and that of in and once about primary more many of start focus a a regrettably, and of on. lot rest today, background, more, assured, filing the too intense But research discussing have so details some it's is our we'll work that question. Well, and the Ed. Not the we get

community, data of the think very the awareness, obviously, is if to be used an at been and looking it's next have physician ERA as that widespread that are at drug the they There out if EULAR. to enthusiasm month to Suffice been line, gratifying, confidentially there have will again talk kind feedback. come as it start well say, for this might top we, how I few, data the a and is beyond this you

paradigm conversation about some I think to community, and the of when will do EULAR, you'll that enthusiasm. ERA treatment talking it And I think ANCA. after in I the the change in folks start you particularly hear think

start too. But interesting, that also in people I disease vasculitis is it's data there's, people, very a not familiarity. out surface, scratching really at the terms even really and it comes ANCA early mean once household interesting of So you looking on. see

Many somewhere hospitalizations XX,XXX chart the higher realistically U.S. And lot a the in combined that I given with to thought in prevalence between are incidence was that the XX,XXX. XX,XXX. would and over probably ANCA than is have

hospitalizations. in And low And of are the the not as hospitalizations. as data as get XX,XXX, middle. U.S., XX,XXX-plus can high You these take you've as that, got short in but somewhere XXX,XXX

got were, accepted These are My planned. a conferences week. health and canceled well these unfortunately, because presentations already of we economics some some over abstracts team had

data stuff So now. at in you'd about hearing be detail, least some more by this of early the

either. are only closest to are medical typically, XX lots but nearly know, death even average. you serious to very between supervision, X/X of getting tragic hospitalizations, in these hospitalizations People these XX well days, XX% not They're over lot mortality on somewhere as with yes, XXX,XXX, a But and of cheap not which, infections, and expensive.

patient data to opportunity been going the in economics that to some that that and good some both here, make care. able really contributions match on way make. opportunity surprising and considerable that current you to a commercial assure I for think the we will I contribution early me, but I So think level sadly real we're the for is just health be of commercial has that of the

-- go and it's more we'll closer to lot we that as a to months on say Ed. have the as about launch, So get

Ed White

Great. Thanks for your time.

Operator

SVB with Joe the of Your line from next Schwartz question Leerink. comes

Joe Schwartz

you Great. status commercialization your It's I to on personnel if you plan and wondering you sell hear think number and your could in faring the type need avacopan of that market may front? great talk and to about well. of that was terms you

Dr. Thomas Schall

field the good focused question. what of environment, work readiness. example, considerable ChemoCentryx, is and even at force, Thank and Much weeks. access physicians. bit We important We've expansion you, in it very Joe. kind done a backwards X and Yes. That's a from really And of can this. like last quite of work things on the for in on is commercial this physician

either Joe, So once are or nephrologists folks diagnosed, seen most rheumatologists in malady. by this

we'll little the bit and between couple potential even next division But nephrologists. months say the the more As a a progress bit about of perhaps little the more, rheumatologists weeks, and and journey a journey Once bit get understand lot more tortuous we but the that is thought, main the diagnosis we X diagnosed, a now. the are to specialties. than little patient those

then patient get preparing and diagnosed nephrology through that the diagnosis rheumatology access initial we're once the hyperfocused journey we and certainly patient So make to to sure communities. on

about fewer prescriptions from. physicians, we of probably lot where know, a XXX XXX. and The their prescriptions than, a KOLs as care. sponsor, immediate and current the say, a now come around probably lot for know, know right U.S. of circle those with I'd XX% We medication And account current of we say,

and or with all every the in increasingly the the vasculitis may So share, a as acquainted will just XXXX already, program medications of physicians few not than in that less movers we're it lion's XX% result be personally each prescribe And year. our of aware of obviously, ANCA U.S. as greater, lot ADVOCATE. they of the key are but, and ultimately,

be liaison reps But XX I or let's of could huge actually and, be a just a the fewer, that's course, really moment sales few somewhere, saturate not to less, more. could a XX% individuals so those could few field prescribers be that alluded a ago. force of field a can about So their force, a as feel combination as classic support of say, force not huge field We personnel, science that number. of a medical a well

the staged fashion. ones infrastructure So behind folks sure a et in course, we have really in, that's of needed. these in we're a said, distribution, to being are being way already that And the a as are cetera, Obviously, have hired all I continuously. access, things, the I them, will people those And player that be effort better field basically big people the But understanding think force and this folks market scope of all put hired lot in together, the coming already meaningful. make a either the these will or we be the area of all hired.

X the in We're ready So launch ready a and be be as for we very taking effective and this company. job launch. for we'll very a XXXX, will seriously at

Joe Schwartz

versus LUMINA-X very of what's most talk That's nephrotic, you helpful. patients, about X in the the rationale FSGS relevant wondering groups then And about I on different if study based populations priority our of you you think and these on could and what how pipeline, might to the X in in see action and X of each subsets nephrotic. these also mechanism was

Dr. Thomas Schall

distinction an, can regions sub-nephrotic. it's is is It's or a populations a not per known a actually the on mean clinically the indication segmental a both either no glomeruli a an lesion is because, or, disease for the kidney, that FSGS FSGS FSGS pretty just is what's cause microscopic frankly, of scarring or larger or officially, fact, part one important is of a a They're se, it not genetic, whether across scarring. that's biologically based primary how scarring it important that in to or focal of has, predisposes are reading populations. X genetic primary. other essentially, regulators, Primary FSGS. the that's known The considered And

actually area understood. well and will is a to is how interesting microscope not diagnosis those to you always be if in the because which an it's came glomeruli diagnosis, So work scarred

no mentioned, there's therapy. So, as approved I and but,

there a breadth not, but science hasn't patient of don't understanding just of kind depth mistake, been has the there's great although populations. done, clinically, no So we of work of lot been make have these and wonderful

chronic proteinuria could went to wanted diabetic be, program, and kinds nephropathy. to in Now we as whether the this it we've inhibitor I we relief also kidney we in it seen occur diseases, Other not again. clearly, considered the, or have with occur to when reduction into including understand as which CCXXXX CCRX other before, And any, of and get won't belabor shown would so I've models, is animal therapy. discussed FSGS as podocytopathies, with

had LUMINA-X levels populations So proteinuria. with we're so-called nephrotic of the syndrome studying,

really has an in its it's kidney a people fact of assault much their of there, high terms These in proteinuria leaching have on including remains what that that is actually the essentially levels out bloodstream, so just capacity. of of protein and urine, their and lot filtering the consequences, in

these So very the community short-term shape good keen that regulators any way, and be will controlled nephrotic trial, likely clinical are if to since that end-stage and impact very have the syndrome-level form in out renal or disease. if see of people, a keeping population can on patient LUMINA-X them the that in

is from they population don't level nephrotic where this LUMINA-X So different generally. of that have proteinuria slightly

disease LUMINA-X. less end-stage predisposed little less the in imminent of a So to maybe sick, renal threat

clinical a out, Frequently, very regrettably they all As different get just in the it you folks, experience end entirely. the these the LUMINA-X are picture people are turns with at options fact, sadly. more and of therapeutic

very, proteinuria. on they are nephrotic actually get at else, CCXXXX where maybe abstract And they make practice, would is and very tendency of proteinuria, a distinction get nice therapy, try theory, of people before in arresting individuals to everything to were the a in stage with nephrotic instead them while very So to this we between trying levels of levels sub-nephrotic the ill

Difficulty] [Technical

very know the meaningful show. we data. other I not do to the this very of So have, know segment result that I a nephrotic sick in don't found do But it's difficult will I I have what the population. sponsors and have to it population. syndrome access work

then So with I that consider different of to be

[Technical Difficulty]

will a a at say, next conditional successful as could LUMINA trial point, lead after, months, LUMINA-X six registration for reduction time with be that a proteinuria result. least step to that

the have community result the and have the data. will as in I as don't order, still result yet, short any we know then So I don't soon well. result very have that But as

Operator

would questions. other no back like currently Schall, the to remarks. CEO, to turn Tom now closing are for the There I call

Dr. Thomas Schall

again everybody Well, of and commentary, I and I on for wish and appreciate the you quarter to being times, update Thank I just you very call for attention. look again thank insightful months. your all to difficult few during in our conference and to a very questions able time us joining forward these next

Operator

conference Thank and you this concludes Ladies gentlemen, today's for call. participating.

You may disconnect. now

ChemoCentryx (CCXI) 13 May 202020 Q1 Earnings call transcript