CCXI - Earnings call transcript Q1 2019

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Operator

Good afternoon, and welcome to the ChemoCentryx First Quarter 2019 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference will be recorded. I would now like to turn the call over to Bill Slattery of Burns McClellan. Mr. ahead. go please Slattery,

Bill Slattery

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

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

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

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

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

undertakes events date this circumstances date May time, At to the to information to any this call revise accurate turn conference pleasure as over is my call. live X, no Schall. of of or of the reflect or to live Tom addition, conference statements contains update this the Tom? time-sensitive broadcast, forward-looking it's obligation after this that In call XXXX. ChemoCentryx only

Thomas Schall

first our you listening. and on joining call. afternoon for to us quarter Bill, good XXXX everyone you, Thank conference Thank

on XXXX are on track as the that positive with continue in slides you we full for Slide objectives call, year laid those conference our the of we out up our XXXX. built see we on We as can X, you during momentum following

quarter. toward understand their drug will unique avacopan is I cover in in ADVOCATE our release this CCXXXX. concurrently late-stage with molecule, of our data pivotal own all our this act avacopan, was on a as era today are that CX or rare often a supported line strengthened trial avacopan progressing in I'll demonstrate ANCA-associated suppurativa the makes disease first that significant a summarize in AURORA our Phase other significant the we area threshold a kidney in vasculitis of cover evidence-driven second, avacopan fourth, because in in remarks as these treatment in of the And our beyond also ANCA; with financial position unique additional the trials by or medicine foray and treatment topics we working each that trial in QX first disease catalysts first, the today: the total the that our the To where FSGS. from X of for could in asset, rights. trials. dermal patients both year in segmental HS; great of glomerulopathy we of confidence my of of stand top attention inhibitor trials with is for pipeline briefly and another with updates, our in trials suffering we After these CCRX lead will disease X address We glomerulosclerosis center ADVOCATE of of will late-stage value aspirations with progress new III trial. with clinical we of the are focal our CXG, the several avacopan young; robust This different, today into in trial Then the kidney from belief this, clinical third, hidradenitis LUMINA the avacopan are CCXXXX outside additional what of new with burden ADVOCATE or strikes what

include: that in taken X, orally treatment the of an B, which would potential the look a today, be with not Contrast So home. an can them. means I'll of pharmacologically of qualities infusion to with if both receptor your significantly it targeted affecting patented unique differentiated a such or on now capsule the convenience know is of that that levels avacopan These help at necessary start years CXa have is the the the injection and a formulation characteristics we Avacopan in to the it clearly body. it reminder serendipity. drug patients design, you an molecule, molecule give landscape Slide even is therapy. at be in data inert with avacopan small avacopan of is antibody is and diseases that this that that by A, in rendering differentiating clearly trough and a improve receptor, specific and

which CXa studies and important. protective levels avacopan has, deficiencies dermatitis cells, model worsening avoiding to to avacopan models. receptor, their the unknown. pharmacodynamic an this itself demonstrated smartly ANCA effect has shown for receptor-driven known exacerbated even CXLX, pharmacology the and that the neutrophils, targets to of destruction inflammatory Leaving environment of have activation produce signal and at there causes example, worsened body. preferable linked through is contact acute one to the which that is CXa an in CXLX is CXa-binding in literature second and that effects. These and been a damage to processes. lowest ways have ability Published targeting indeed, to and validated is CXa of alone migration disruption We vasculitis through And C, different collateral that this D, in CXLX in CXa are -- happens pathway the the many that in pharmacokinetic vasculitis injury, other is effects avacopan showing of ablates the diseases. stopping inflammation essentially lung and disease CXa targeting of is in the different enzymatic CXa And amount the local finally, essentially receptor

in For is are is of example, very while inhibiting that X present these needs to the receptor have only it be good By to people CXa CXa antibody vivo to ligands, total nature understanding do targets, the contrast, the as challenges is data fundamental CXa proven on in grand human vitro know understood to a pharmacologically CXa the in the needed receptor And CXa that and what avacopan. in is with but bind that to Thus, not advantages differences inhibiting inhibit we what and ChemoCentryx two needed. suggests go we the in itself beings. there don't receptor.

Let analogy me and quick give you to a differences. these illustrate simple

cannot a and key-making be one depicted our can key, the of of confidence have clinical it forward It provides doses cannot Slide with we If X about of is community to reason targeting of deep months care antibody, in truck standard you're every a current superglue to you X million. favored has us steroids, trying X. to each significant of results the Avacopan lock your limited or and thousands high-dose with The prevent don't keen up matter unlocked. ANCA-associated that in we of and have regimen. house is on superglue, daily of the with causes, door. high That's a or why from date key, The and has the the ANCA trial our thief pivotal thief even a small mortality The unlocked. XX daily to know ADVOCATE III looking X a keys, be pragmatically keys one because powerful molecule. your future many are in XXX if you avacopan lock X investors doorstep. generated getting to particularly The the doesn't That the with vasculitis coupled morbidity put steroid is with Phase into immunosuppressant, interest need data vasculitis, these we success. you with pick of the keys lock patients, antibody, always however, receptor so on whether the

active therefore at looking so-called trial by ADVOCATE avacopan a with of remission at weeks. starts symptomatic induction Our or XX months X

Vasculitis symptomatic at weeks active Activity vasculitis instrument the assess BVAS. remission measurement controlled This in will using XX called durable trial will fashion. by Birmingham then done or Score a a symptoms clinical blinded signs We measuring be and

you Just as captured on is trial also the instrument, trial, BVAS by depicted though, which can burden most important in graphically we ADVOCATE disease, not clinical are which the X. of total Slide focusing on see of BVAS beyond the the

that the BVAS by remission assess vasculitis; illnesses of symptomatic using assess to in damage patient's measure in of ANCA the are show validated to as ANCA looking quality the elimination improvements to in by of also we part of are also, therapies the quality the today caused standard the accumulated measurements. care life of of only arresting life and not organ used So but to very

ready? the year pharmaco-economic in quality on contribution in improving of for that to with a top for with in expected than as time line of and line the expect positive rapid will full that large be well-being Europe. ANCA remind ANCA and of life U.S. represent the their total we marketing in less data when forward QX sustained This So no focusing with are the data reducing in release vasculitis, released opportunity. you well of ADVOCATE will patients regulatory next and disease We a would approval readout, these this to look huge data I on ANCA In senses After vasculitis of making QX are and remission and submissions short, the of thus we year. demonstrating term. effective, people burden as in be track to vasculitis planned our all

trial autoimmune $X now market skin in to disfiguring only one believe as X. for is therapies effective the and this where therapy Let reluctant features avacopan a chronic, become hidradenitis opportunity of we where suppurativa, AURORA better over to themselves Slide considerably the are you the in depicted patients on mind our manage nodules, annual stand to point a some in believed as to disabling therapy painful There disorder, expecting in the have abscesses available. dermatological HS boils share clear of which moderately in keeping me show today significant market We can for to HS, public. disease, this us, need is with expand with billion the that and is be and sales indication,

neutrophil-driven in in Chicago, investigators a HS recall of very a that will disease community by is patient orally our CXa avacopan we HS attended. an be its You meeting treatment will first December. will which activated in administered that the long-lasting the solution. Last receptor, The AURORA dosed we CXa was be to is convened want and month, hope option. Since receptor -- well prove

pain, studies. we follow end in up the we XX-week Our the additional or metrics suppurativa clinical validated endpoint aims score, by enroll an trial assessed moderate of patients for patient. all period, AURORA is weeks. initial will end XX skin life Humira the treatment quality at from severe using of and XX HS hidradenitis point will the to primary Key pioneer HS. secondary weeks placebo avacopan to importance After versus points groups The XXX the the accepted other to follow with a trial FDA -- include response HiSCR

of we we'll activation set run up We precedent the of ADVOCATE of enrollment. In predict sites running, accelerating have be get Once this overall to trial. able on rate year reporting we and the sites and follow in majority been patients with that the site better we'll per clinical progress, the AURORA.

during to this -- Our line aspirational We registration like to would unchanged. release complete trial data in goal XXXX. year and this remains potentially top enrollment registration-supporting

third late-stage with the is treatment avacopan of of in CXG. trial patients Our

patients Our expanded can X. randomized trial control includes on strata a design two design, in see Slide XX you using as

change. this glad because no XX% recently, strikes which approximately of enrollment. disease. the and a is It reached Enrollment it disease somewhat partially of reflection slowed this rarity disease. have the therapies, disease is terrible we that I'm FDA-approved something to rare a a is has young intend We with

keep the using year. assessed primary data top to will of of informed of still be hope progress will the next receiving at empirically releasing group point to our trial histology index our derived care. the X renal year, We and standard here comparing this The therapy, months a line you end group complete avacopan

glomerular disease shed have avacopan, and of collect that on are from as filtration the in X, changes changes in rates. in X away dermatological successive We other disease including readouts. first will prespecified line our also two for kidney urine in and points, end To reduction in top shown quarters we X expected are in proteinuria, kidney inflammation Slide markers we and opportunities two summarize,

as year march second CCRX and small call we on inhibitor, conclude further trials value unique two next, FSGS of addition, the of could segmental progress In of for focal this I next, data asset, of our with significant review or will trials I a going hear which forward. opportunities late-stage the total our our CCXXXX, this catalyze what shown of molecule for treatment glomerulosclerosis grand Slide XX. have you through underway will X all

trial Phase in in chronic which will you significant is Some indicator a the proteinuria, same we a molecule, CCXXXX, II statistically a kidney of previously, kidney recall reduction key disease. diabetic for in that of disease demonstrated

surpassed in a be to you the the continues XX. enroll trial to At of enrollment, LUMINA-X and as our now very trial LUMINA-X well. level to this from middle rate is as rare consists ChemoCentryx with second The CCXXXX of next sub-nephrotic of our enrollment by so-called to FSGS. complete Slide summary, out next and group We we should drive well data of year. have patients, take primary year nephrotic patients this XX% it In underway, can enrollment see in able read of

in III clinical closer with are this line Phase year to from starting succession We clinical value-driving X data a another readouts QX. quarter data ADVOCATE top of delivering the events, trials,

that the million of you to generate develop to financial has underway. in possesses enviable robust to position issuance very of the our drug million. strengthened we the over to further remind quarter been turn near commercialization net Susan? call novel the in of now you further for CCXI from our addition Susan ended an top-tier by We with base for that drug opportunities United that of preparations shareholder expanding would candidates $XX.X during and of the institutions. our position. first the like quarter all States stock, $XXX in already Meanwhile, proceeds Our financial are XXX% platform common to details I our rights continues discovery I'll future. our hope the give with

Susan Kanaya

Tom. you, Thank

period enrollment Phase from and Research first XXXX compared clinical $XX.X employee-related XX.X to of primarily the with quarter with trials avacopan million a quarter Revenue are fees. to were due of million Revenue The higher same the CCXXXX including Our to and professional FSGS. XXXX, the expenses first Total a the were on $XX.X agreements. was period for increase partially and the outstanding loss commercialization Phase in III was second collaboration quarter increase release summarized the quarter funding for expenses, the represents recognized in million were in of today CCXXXX for was primarily same efforts million patients to million compared in to pivotal in results our XXXX. million million and the Phase included The were Slide March license the shares. increases for first same million financial XXXX. XXXX. net administrative first offset period the amortization in $XX.X enrolled Vifor, planning higher XXXX $X.X same in to $X.X and avacopan the from to as expenses our shares compared for press study XX. XXXX approximately pursuant $X.X $X.X fully initiation to first by period XXXX These the XXXX. II fees, in avacopan the and the XXXX were decrease the XXXX. expenses compared quarter to $X.X in recorded development was patient of upfront clinical General milestone XXXX XX, payments XXXX of from for due ADVOCATE trial and of those patients trial for million with HS the and for half at associated We II

stock during full from quarter cash, to first investments. facility in reported of As of the proceeds million quarter, the and ended due and our common with million utilization raised $XX.X cash the issuance $XXX.X net Tom first we stated, equivalents in ATM

our in earlier in and the $XX Tom? range investments expect Lastly, of to utilize guidance, continue with cash XXXX. $XX million consistent we to to million

Thomas Schall

enrolling To avacopan and trials you, summarize, momentum of we as Thank HS patients avacopan CXG. in or the trial in beyond remarkable Slide generated CCXXXX our the activating Susan. progress halfway of see AURORA XX, mark in considerable you XXXX, in and and can sites from have in FSGS reaching the continued and we making for

of on data within trial of line of be that are in space readout the track for months. will XX year. top III We QX five This data should Phase this of ADVOCATE top occur the line our first readouts

still Our our results investors. just ago, XXXX reported financial on we I of our than impressive household strength when year greater some two list names is and to you to added have months first full

back an It to -- With over your is the number Our clinicians and there a pipeline our towards they will innovative our seems and that, operator be now ability or to for products questions. to of the progress execute I attract our on of goals. tangible view people, sign ambitious increasing patients. look investors was by for considerable whether to or CCX of turn inexorably this that plan capital Operator? and make real and shared the enthusiasm ability return forward call is our potential

Operator

Instructions]. [Operator

come from Our first Michelle is going question Canaccord. to from Gilson

Michelle Gilson

do expect would do just expect how in broadly, you AURORA following patterns you cleared you up just you about to you HS. lines I then the a and kind would and And disease HS view thought, talk expect that see that the response view -- ANCA? of CXa And if mechanisms rapid pattern? you bit in similar similar observed of disease receptor CXa on pattern of drivers of them the pathway of and guess as and response generally? curious consistency little the for along Can a more that maybe targeting you as just more what response as you kind similar, previously of that I'm and if about

Thomas Schall

similar All neutrophil terminal component in excellent We seems vasculitis that -- measure complement and Those patients measured been patient HS activated, known to the activation of in It's patients. is blood. a questions, to we elevations of them know been Michelle. there seem what's number sort years in again Thank to to when seem as that elevated be they fragments of ANCA be for the complement we HS ANCA markers vasculitis. quite see in blood also similar have you.

parallels overall HS of is the neutrophils. ANCA certainly the and lesions, are there the prevalence profile activated So well about those infiltrating seem high fact, patients. over HS in of a be biopsies years, complement skin many as in of in associated back been present There's vasculitis almost with as going data to how certainly XXXXs, patients to

hair the and it at vasculitis. the or then vessel. surface under the So core reaction necrosis with and of et disorder, hair of lesions of the disrupted in cetera, ANCA It's as seems the all at in blood to and vascular ongoing sebaceous typically sebaceous the disruption. location of presence or whether follicles vasculitis. merely hair ultimately of is glands. inflammation CXa disrupted which at with it's complement It's interior just obviously, blood to with the a skin, difference vessel it's the the much in the a around dysregulated in local neutrophil-driven of HS, glands, And And follicles first the at neutrophil-driven HS, around data follicle be core the receptor-driven point

where reasons, those feel of have to global yes, anti-CXa very will assume approach is there all going be level really receptor at a an for that well, example, least exciting. of the for rapid I the response. would And So we at pharmacodynamics, --

avacopan II again, disease science. neutrophil our the That could within good this a that of down detect showed we with vasculitis was going range in current example, the to neutrophil-driven ANCA the couple normal That days, is right studies therapy. as for of levels Phase a HS. since middle news is is So we

the which small and And ongoing getting short actual is neutrophil perfuse molecules an so seeing get we the local feel these inside the that even lesion. small efficacy good the small has and and advantage to That in that we'll be order. of of to damage maybe means clinical have taking molecule, a of goes too in will, destruction that one site and nets, environment and to place, underneath and may chance have suffuse continued will preventing if hopes a replenishment molecules advantage destruction need you an to where

are, therapeutic now I a a therefore, that small to part that give an may over fact, localized so But your answer fundamentally, just third will So to antibodies be in get is mouse a backbone being the take in and to do the again, perhaps such immunogenic the and which getting merely be And to tissue. longer same kinetics as any getting and they result of to to part. XXX-fold leads might the XXX- have. molecule? question, antibodies going necessarily beyond the to and third neutrophil they molecules, neutrophils also as lose than the the think they on fact to small we're action, antibody work the nets, Would might that time efficacy penetrating site difficult of local molecule through in large environment by have trying very these use challenges other bigger the ours, they're

biology beneficial complicated So that which CXa is seen called our second receptor a of CXa breakdown lots and approach binding will the of kinetics throws the products be nothing upon be out antibody CXLX, pathway actually that approach, to of takes CXLX And say second that's versus with there's also CXa's to antibody data an approach immunoprotective molecule of or to small whether where course, remains the same. incumbent an the the signal.

action to in drive have clinic those to think those to out even lesion local the response, work molecule challenges approach. ability complications terms and antibodies. of I the at we effective of action with That's in the why all or be a cover chose small mass time how target, the So will

So if comes we'll need decide we'll out obviously understand and action data the mechanisms we relative the see then of how more. to

Michelle Gilson

just if for In like avacopan me a from HS a flaring? that's And would you treatment treatment flares, your you and disease chronic like see see follow-up is And I if use a to just view, antibiotics Okay. may. patients where do have their…? as antibiotic you you then And keep potential in? a talk well fitting could in where study little bit as any about AURORA the a

Thomas Schall

Sure. right. Right,

therapy. So true utility, glomerulopathy. HS therapy CX first, that vasculitis effective I It's as to will the chronic point in well. ANCA think be true ideally in of That's in

cumulative have prevent HS, a and lot the ongoing as want disruption is reversible. example, In and scarring being we thought You is of damage. to scarring and for dysfunction typically

keep out over arrest would to one and of any can some contribute like people One time. even effects these like disease flares. them of to to would So of kind

from to indication an temporary think flare. we relief knows out details and long-term is I may be quite that Antibiotic -- have therapy it So work best. we'll a the know not will I does common, provide that but acknowledge provide everyone on But basis. use indication chronic it effect by

system complement you So may while destruction, the need is to the get activation. the infection, core to problem clear antibiotics still which of the

be until to brought in sense, have system going a But that. the homeostasis, is, back in an Now may you're naturally, complement ongoing infection contributing problem.

the with antibiotic the of use think is of I an -- So antibiotic-driven infection. that question. the lower levels But responses interesting are antibody suggesting literature is that probably associated most

have is a our strictly is carefully reality impact large arms and antibiotics that results, given in very A, is: of So antibiotics that B, overall so are the fairly balanced use the and antibiotic we doing so stratifying we it end in of trial. protocolized; this the use our stratified concomitant treatment shouldn't accepting make our are study in situation, we are to what sure while used how

Operator

And question Ha from going our Gon from SVB come next to is Dae Leerink.

Dae Gon Ha

apologize for I the And background noise.

and X on X quick two Just from questions AURORA. trial me, ADVOCATE on

be So the us [ph] the population. U.S. press on release, what EU? you mentioned in ADVOCATE, across Tom, you Japan approval fishing in And for can bar see now remind you the would and

regards to fall And So your BID, antibody these give sufficient study, bar? doses? on a that XX-milligram you're seemed you earlier patients XX-milligram confidence certain monoclonal where like experience remind an saw that in does presentation state. what going to you chronic. need the so point, with reach can just With regulatory you and AURORA, that other curative some from it Japan us earlier you necessarily At don't dosing do

thoughts your milestone of are what So terms there in reaching that with avacopan?

Thomas Schall

Sure.

of any being So as Phase alternative were was trial. an study indicated doses cyclophosphamide, regulatory RAVE off of so in point importantly daily X, to for being in is given been to RAVE a rituximab XX offered also milestones of to that have way in steroids was end patients chronic which ANCA point score addressed chronic vasculitis only with the previous study analogous really the was plus primary essentially X III remission ADVOCATE And that the least steroids. called steroids weeks. at And BVAS weeks. The going XXX-patient chronic plus the a by X of was end trial. at doses the so-called primary symptomatic

And precedent a alternative dosed as And for approved the both -- cyclophosphamide with being steroids. backdrop rituximab an both a that's to really chronic backdrop us. only as was so regulatory as

background which to was remission standard the numbers XX% the the And months defined. XX% time, were of therapy, X effective was symptomatic at them and getting as at rituximab So care was effective.

in that trial. So the confidence was rituximab defined was numerically superior that not but inferior interval through statistically

similar So at week trial also format. a essentially very durable to looking using regulators at example. XX looking We're we're XX. appealed week and that at the then for We're remission

rituximab though achieved we we quite So that achieve week RAVE glucocorticoids of the made today really of trial, the burden the RAVE about regulatory seemed kind Safety wasn't much at both come follow and the Europe. Japan problem. any and think the frame trial rituximab, as pretty are XX different being in the result. I squarely certainly end a interestingly, the U.S. disease the Europe of United RAVE because groups, remission of for on results X-month in the week between be puts approval that the And also that aways XX, and end was we're I've confident total States. of we the to beneficial talking point essentially, week at in statistical stress only If as if precedent time the fairly I same And really confident will has XX. biggest XX endpoint point achieve the since field point will that X week the spotlight safety during

the significantly So keen well. glucocorticoid-related damage showed course, in we of ongoing be that about something vascular steroids. quality to steroids. avacopan of cumulated improvement the be that improved in be organ and the measure want They with of doesn't also of which life are the to get the first And other trial if lot we the the in be to group the time chronic arrest damage ever CLEAR to a for chronic know significantly will going avacopan absence as people will know in metrics, very diminished can to toxicities the

across question. that's we're line before it other think regulators back to be the data in of it again, your the data how of as to will I of burden that top the said present say around the to and If go world, going I've interest package So total I'll well. it I some and disease

far. least label to about small date. would it more So you antibody see point. this were about know need I so out to the curative effect. so-called talking set data use an data the I to I in term Suffice -- the a say, we that's HS that's It's open used at very study. at data that there not

Let's like other durability say think mysterious tiny the bit is little any skeptical just bit even therapy. of a of of than natural or CXa even anti-CXa effect diseases I'm HS ANCA. but I receptor history more a the rare

is data. remains to I looking be I the we'll durable be and will once homeostasis, make clinical reactivate that sufficient But longer-term challenge and there's so So establish that that a the say, to back homeostasis big complement claim until perhaps complement far evidence seen. it at system, could suffice think keenly to not next to then a one gets think all

Dae Gon Ha

Just you've after ADVOCATE. of right year for one a to enrolling I now. I just got events one. final cadence know number of wanted next trials the the clarify

thinking how terms cadence we in So be should about HS, your CXG the studies? in readout LUMINA of

Thomas Schall

question. great great, It's

have over surprise at we study, the the the optics It some of which in the data year LUMINA approximately we ADVOCATE if possibly we're this line have nephrotic in Middle half study. multi-arm LUMINA-X half, middle, year, QX. XXXX, the LUMINA-X the from of from maybe wouldn't clearly, first looking first data is the population study. with greatest top me nearest-term event, So

all somewhere well, little potentially get And general enrollment the subject of in are that the next forgot of half a question. quarter year bit and perhaps we'll Gon, but HS, there, or to we'll year. and about By middle These generally other the your we fine-tuning about I in way, to know I through get Dae change and the out. that would as a CXG cadence. And would two be mid more go rounded say the second

levels asked chronic study placebo in efficacy. pharmacokinetics get powered efficacy essentially readouts was consistent consistent with was dose, the coverage be weeks XX% but where that extent was efficacy receptor CLEAR they're again were with XX we trial a where XX the populations, and II trough similar for XX. trials, ANCA of with XX. we for X drug even but It doses safety after had trial the not a the designed You the several care, the XX had XX patients. some Phase where certainly at basically effective In that efficacy, study where and used some appeared features pretty less. in patient But between Again, HS and group was of the we clear that trial, it steroid. did ANCA vasculitis that vasculitis standard it and including to with was the full-dose to all we a have full-dose about trial necessarily

X HS same clinical so And of are why sort doses forward experience, dose that's we using with moving in those regimen. which with have that we

Operator

Seedhouse comes Raymond next from question James. Steve our And from

Steven Seedhouse

avacopan's you quick Tom, pharmacology. Two on mentioned XX% receptor questions coverage.

those and what, between BID? Just Do guess, that. levels, And mg if of the the mg? of inhibition would XX AAV a And then that I different CXaR in follow-up just you XX change clarify, is XX-mg diseases? do relative you want the that to inhibition CXa two to related see in another pathway to think they are HS and CXaR patients

Thomas Schall

But key they do binding are, think in is of impossible if environment don't say receptor Number I if But the ANCA. with suggesting what concern be issue XX-fold, are really different. again, current questions. if levels data going happens that that would up disease with the happening CXa versus I X,XXX-fold they much even is not the deal that's to to where great a that But are the excellent one, even HS even I XXX-fold, and a even they're there's technology. know and receptor. in different, have an That's

you or all every every we're of right single activating to you in I you this primates, And neutrophil on by receptor did pharmacologically going and a mainlined the blood the variety to we do the intents in every circulation this -- after model up CXa just in and to purposes. blood, every think them measure all neutrophil. saturating something essentially injection that delivered of species CXa neutrophils for that interesting X into of experiment neutrophil crisis suddenly just molecules after pro-inflammatory minutes, gone XX blood and are lung, CXa they the that is the really And they're and in about each in as never their happened the to go blasts a of spleen of it's crazy presumably. blood. the every vessels But especially. they that, liver, into upregulate adhesion you surface that the like stick from they reason And response. find the out measure gone you neutrophils CXa, pure pure make infusion when that receptor the where nature neutrophils, that inert when we try an to do We

And out so come of suddenly, the blood.

like that transient in vacuum have your looks neutropenia suddenly, a you like neutrophils cleaner blood. someone So

CXa is CXa. receptor every with that's important? getting why like it's neutrophil, stimulated Because So every literally important, that

said dose inhibitor can transient a inhibit are, as an a If primates, primate I need that to depletion. that confidence, friends much to get so depletion, and of dose board you, I'm inhibition my that up neutrophil to and if animal most an you XXX% can you animal of how you shows right on and of great degree

in inhibitor, this species. that CXa in that that to sort multiple in about done It case, we've patients, Longer-term so avacopan is depletion twice a mg in in nanomolar inhibitor human, day, stop nanomolar. fold. about XXX at need active And essentially, if you XX of complete avacopan receptor of neutrophils. even actually receptor you out And of experiment few short-term metabolites, count a accumulates of the the exposure levels experiments turns trough CXa it XXX

handily volunteers even in have lowest So healthy corresponds in we that And assessments receptor humans, the all of levels diseased sort at in and of we've the PK/PD body. subjects. covered of drug done the in the to both the

you that approach. a Steve, XX day we're don't thing the know to conservative great think, and be to we that I degree is, at above. receptor most again, confidence, So a We level hours covered. the of taking very if have the is And know

We are certainly at at level lowest drug. of the that level

drug area trough under that counts even bursts the than curve happening have say situation. you biology and peak in concentration levels, really a better or you If in we're is count then of the more

our extra So at on we we've doesn't taken it's of really the CXa it. test clinical much and again this that that our out suggests feel, based of say, then data, in tube done those all all commission. we've reasons, throw stuff how receptor just And experiments matter other the it I you

get receptor perform going to biology. activated You're just to its not the

think ANCA. That's ADVOCATE clinical I why the III and ANCA we Phase HS I'm why in II indeed, in in we're in CXa in AURORA and go forward for diseases. benefit that's trial neutrophil-driven optimistic other So seeing Phase in as

Steven Seedhouse

is trial, that completion registrational following again, Okay. I about weeks trial. this of registration XX where and think, being analysis through on think, for at minimum? And spoken you assuming Is HS I how patients important potentially full, the potential that You've are a XX-week even follow-up treating the longer? a through, secondary

Thomas Schall

standards naturally much what those all discussions we're without do agencies, or And primary Steve. regulatory again, whether beyond wish not of is drug fairly adalimumab is apples-to-apples to is for the the that question, to great are lack too is obviously And detail weeks. there know XX and -- will, that whether it better if comparison, matter word. a weeks, the going happens with where for into have We suffice clear, and are which others to as trials endpoint fact can of only we it's see, trial, was the the precedent, what meaningful. best a the about that you The really so same Yes, sensitive, but pioneer licensed it's much to using the an HS. say apply first endpoints we can Humira regulatory looking efficacy XX

all we that's far, so to And have work with.

that way but look in we're And the we'll be So what trial there terms do frankly. that's to obviously we yes, is dosing, both through we designed thing the will means beyond label need on, drug the and a important I period is naturally, most think where that focused of that away. the registration the and primary we as XX-week And the taken why interested is in the FDA, of and to weeks XX help discussions determine with we well active follow-on what the did.

Steven Seedhouse

Okay. question My is question actually for last is a multipart Susan.

decreased quarter. related your that -- the avacopan, collaboration expenses agreement for the corresponding operating the this revenue to On just and

completing. mentioned you that of ADVOCATE think enrollment the was I trial because

indications just terms sort to beyond? where that's of half apply costs spending likely I that for into you further And just So back of avacopan-related avacopan? of different can onetime revenue guess, collaboration due in is of recognized go terms question anomaly and the expect across the to the this you year and it And decreasing? a first equally agreement the clarify

Susan Kanaya

for questions sure. great. Okay, Well, multiple

price or and avacopan So the -- it the CCXXXX does to strictly how So tied total the respect it's the transaction revenue, work? the to proportionate agreement. transaction with rather to just cost

upfront the the take under recognition your of proportionate then funding all fees, payments all to at expense. you of look as in proportionate and of a and programs activities you your roll the all a you when this then percentage completion and milestone So costs alliance, complete

down, went onetime right, to that because kind effect. you I we're large ADVOCATE kind and this as degree think enrolled of proportionately, amortization, of offsetting all that's Steve. see then a why but So HS it's But fully

I respect because cash it's much I'm was part upfront pretty your the... all the what to with -- do we've right? question of How received, other So sorry, that

Steven Seedhouse

Yes, I that's was going of just or that into HS. the how and this avacopan of just to if of up was, on the to curious that spending sort the going progress is how going, is in and gauge if this ramp thing sort onetime a fact, beyond based half year back

Susan Kanaya

I not part sorry of sorry, contribute one, to say yes, a only missed HS that of question. would but that it's lot it's off-clinical That spend. because activities your the Sure. total the I support other

Operator

Piper from Jaffray. Tenthoff Ed from comes question next Our

Edward Tenthoff

And you for then ANCA-associated filings, be, vasculitis will do are it the think, of here. which sort that? quick all supplemental kind follow-up. three avacopan HS assume they of mine about we're positive, I things. on of file CXG first to and new you ground let's some were a then and what's current sort or I do But timing to have So of up asked. But kind wanted we're your ava of would for breaking hoping pick that for studies of Appreciating thinking

Thomas Schall

that you're Yes. it. no of reasonable about sort kind right, of an particularly sense, And be thinking are therapy dermal question. there's think of way to But as think makes Great. modalities. ground, indication being example, treated with by a a current I It's CXG we interesting especially our for FDA-approved is new might breaking all for NDAs example. a And since, separate X so separate way that third

X all data, has common, are going that's asset that of that the be the all since would there'll in would to think all would filing. would any is virtually quite big past that Now with I trial over out separate I'm of a the one would NDAs sorry, has in The and meat is and safety database assuming ANCA done naturally, its be it first, -- which that ADVOCATE all first in be few mature U.S. the the But off-clinical And I and those be -- that the filings. very stuff of will processes we advantage to in all in going of its be the the CMC to fact the obviously with ADVOCATE, filing other positive the most done work case the clinical vasculitis that's history years. we've read terms common.

Edward Tenthoff

probably conditions. thinking that sense. to where a a how pricing and be of larger we then it's we're we about HS, one lot with And and of But spanning little the ultra-orphan Great, here be orphan probably realm makes early kind because should of discussing this. orphan then have conditions

be middle? would those have some but there. important do think an Do just early the could Obviously, a in thinking terms impact? data bit in kind of So of split you little you

Thomas Schall

the question Yes. you good an saying. really But you I give give wish it it's which to with a here's and the what envelope one I we've been is price That exact. could in

the model penetration double-digit to more if have capture ultra orphan, we you. we you're bit about we're orphan, of again, little just focused is looks And have super or course. time, for accessible corridor. low, out market population you if thinking what I that do U.S. You're lower per U.S. were a once and data, penetrations XXX,XXX of limit, And all But to the and small vasculitis all aggregate HS. the the sort lot probably and corridor their and absolutely pricing been normal the guidance you some if very work we'll the on or XX,XXX in you revenue well we pricing billions modest our order orphan, a mean, those just conservative. right. probably of orphan something really they for need the per millions you're in patients just provide limit what to I that from in us, the the difficult to hundreds and do it's we've can U.S. and saying population more low take this we've But there's year, a just as of to like, But aggregate, to just in to straight-line single-digit in available of, profiles. the say, our order all upper have over get percentage, X market over for first and ANCA indications percentage just own conditions to right, of own probably the drive And rights building on in CXG several we're years. all where the the you've several potential across year, infrastructure, XXX,XXX commercial XXX% XXX,XXX arithmetic then avacopan of something on to got modeling in what avacopan

there digits corridor CCXXXX, So U.S. to of could penetration we're not challenges about revenue We how in second that in that's course, more access. based of digits low it. asset, doesn't And the on include another what And sort of the even obviously our value of we think know about enhances how XXX,XXX business the to there. XXX,XXX go the again, as I that think thinking potentially single a model. just at considerably where of just showing world this orphan of you add kind we we'll just and super will double patients mentioned hitting thinking models about point or forward. We orphan pricing, be be we're pricing. We need the normal

Ted. it, we're that's So how thinking about

Operator

is next from H.C. Wainwright. from Ed White question Our

Edward White

now? So about can us commercial you update of and building where are just give you maybe you just something mentioned an a infrastructure just right

Thomas Schall

They're be to early a -- commercialization include traditional what raring team. shirts, to the field will Ed. for MSLs as We've force hired reps. good starting looks we've bowling the the force obviously models very got some like. serious, sorry go, No, well to whole bit. so our build Field We're as

or be here, chiefs seeing of about -- at Ed, let's driven internally, Most folks the terms moment. where is will nephrologists of are vasculitis important med our in ANCA early just for for a least be those is to discussions The And are our here. by prescriptions going points, their are early affairs our commercial fact rheumatologists. chiefs for talk

As manageable. you is in fairly the full ANCA know, picture in patients full a network ones even node fairly smaller population, stop. said, the that larger I or as manageable the that that's network, But fact, that even

that. together total those all field and the to drug. in already work professionals market again you'll starting to and down putting crew our that's that need we're place project we infrastructure. And working force, up So from specifically force the of are We've backwards we laying business got hire that to processes the be of doing other which of assessments launch to familiar and when field lead the

there the processes drug that's about good on commercial have out get hire go we to we've I'm think practitioners. distinct to business into say And So or that have to to staff already we start processes the the that XXX that preparation. the staff business then and the happy actually XXX I a staff handle that going those to and additional hired

Edward White

a completed enrollment giving XXXX? occurs to where And my in where to talks were near you [ph] most XXXX? have of enrollment prior answered, mentioned from near-complete on change XX expected other slight a are study more or maybe one I but avacopan in -- have thing that questions Slide it is just you Is that bit have I in had Or be XXXX. yourself you leeway little complete AURORA

Thomas Schall

said, is a that's bulk said, for soften us I or And the it's language a aspiration, is as that. the as extent doesn't read be enrollment our Yes, we of new data compete in And it year. second should read this -- but we've to we've a bit because remains hit correct the to space our prediction that that. half changed Top not fundamentally, I wee get change I think aspiration our data able so of to said when line XXXX again to before, going that we out. XXXX

So to little mature more as we crystallize just trying a the bit program.

Operator

from question with Rama JPMorgan. And Anupam comes our next

Anupam Rama

progress. on the all Congrats

last the this a Is on couple enrollment. of total there up quarters, of on the that dynamics question Is feels hovering XX% there something around speed your enrollment of been enrollment anything going relative in doing there? like you've there to It are expectations? CXG the you quick on kind to enrollment Just guys trial.

Thomas Schall

question. great a That's Yes.

So started then had bursts. slow the CXG we and Anupam, we with trial, several fairly

and will. be and there's so again. for best our almost were there then so fact And of also of in rare these the into And is to stochastic I bursts, in clinic the you're expectations. the if patients that we It increasing of the associative slowed right, disease quite we terms enrolling competition you down the that could in space ahead while, design record top the This either of we're kind coming a were race be think certainly kind time moment one in it at it's could of a mind. that of trial the and CXG getting

could disorders. as itself encouraged maybe be whether now not so about reduction because proteinuria more also our lately the in lot the a or enrollment in in And proteinuria has And used it certain could players, there by a and people FDA candidly, part endpoint then registration rate. been are saying be were

way, But endpoints." also are we features affecting the that I But proteinuria will so one of "Well, be and histology a the the more lot of enrollment. definitive has trial do saying, all more, definitive we believe, and by think let's our our a as may more endpoints. proteinuria those we just have And makes answer. require people trial prespecified

direct and with good And to not So even we enrollers to certainly will. hovering, field that what now. actually this are you sure are We're finish make in that up trial? and the the out arranged we're sites behind we're fall those peer-to-peer we the more going that We mobilizing are groups, we still are if contract. doing doing? sites. What certainly We've can between adding meetings

So have a so you year that. going I'm fairly soon posted a readout XXXX. coming on and this see we're we'll believe fairly CXG still picture We optimistic keep to we'll on that different

So overall, same. looks, for the hope, we us picture the about

Operator

FBR. from next question Riley comes Polishetty our from And B. Harshita

Harshita Polishetty

me. for while a cancer. Just in a quick been CCXXXX one discussed pancreatic It's since we

Just wanted this the next expect should updates steps update an we how candidate? get and about for are this and/or on what to company's thinking the program

Thomas Schall

question. Good

tumor the lead the on time We of of other cells of advanced in microenvironment. So had and programs and advanced farthest myeloid-derived context we a strategy a showed on making alone, of an have the things clinic overall focused increase in the most traditional survival pancreatic these certain as context resources. are calls, months quite very XXX encouraging focus the clearly, cancer of of in But right, investment we're at about -- where our that Harshita. We encouraging. we're result XX% inhibiting to the to with we suppressor chemotherapy part in XX% XX over you're

to the in of context forward our is aspiration So there partnership. some including immuno-oncology assets, our take of XXX

XXX. when into those we have background, fully discussions plans are picture able They'll to continue to definitely bring to -- light, are we'll of the in ongoing. for consummate ongoing been an bring appropriate that the So be and partnership, everyone and we'll

Operator

Schall call closing I the now remarks. over like would further for questions. And I'm turn to Thomas to showing no

Thomas Schall

and and to and all look we like afternoon. of would updating today and call all to I I our great Well, I evening further thank participating wish a you you for make everyone questions forward progress, stimulating as discussions.

disconnect. now may You you. Thank

Operator

And have ladies and great We day. today's you. today's a concludes for Thank you program. Everyone, gentlemen, thank all participating This conference. disconnect. may

ChemoCentryx (CCXI) 6 May 192019 Q1 Earnings call transcript